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PubMedDate not supplied

Peritonitis occurrence in a multicenter study of icodextrin and glucose in CAPD. MIDAS Study Group. Multicenter Investigation of Icodextrin in Ambulatory Dialysis.

OBJECTIVE: To compare peritonitis occurrence and outcome in a large U.K. study Multicentre Investigation of Icodextrin in Ambulatory Dialysis (MIDAS). DESIGN: Prospective, randomized, controlled 6-month comparison of icodextrin with glucose for the long dwell in continuous ambulatory peritoneal dialysis (CAPD) patients. SETTING: Eleven CAPD units in U.K. teaching hospital. PATIENTS: A total of 209 patients established on CAPD for at least 3 months (103 control, 106 icodextrin). Twenty-three control (C) and 22 icodextrin (I) patients experienced peritonitis during the study. INTERVENTION: Patients who had peritonitis remained on treatment (unless CAPD was withdrawn, temporarily or permanently). MAIN OUTCOME MEASURES: The main outcome measures were the rate of peritonitis and duration of CAPD treatment prestudy; the rate of peritonitis episodes and their outcome during study; the effect of peritonitis on laboratory variables, serum icodextrin metabolites, and ultrafiltration efficacy. RESULTS: Prestudy: Nine (39%) of C but 14 (64%) of I patients had suffered previous peritonitis episode(s), with overall rates of 0.58 and 0.78 episodes per patient-year, respectively. DURING STUDY: There were 31 C episodes and 35 I episodes, with overall rates of 0.76 and 0.93 per patient-year, respectively. The increase in the C and I groups was 31% and 19%, respectively. Serum osmolality and sodium levels were unaffected by peritonitis, and there was no increase in serum icodextrin metabolites during peritonitis. Overnight ultrafiltration volume during peritonitis (mean +/- SD) declined slightly from 218 +/- 354 mL to 185 +/- 299 mL (NS) in the control group, but increased in the icodextrin group from 570 +/- 146 mL to 723 +/- 218 mL (p < 0.01). CONCLUSIONS: Using icodextrin for the long dwell in CAPD does not increase the rate of peritonitis, nor does it alter the outcome of peritonitis. Peritonitis does not affect uptake of icodextrin from the peritoneum.

Chlorides↗

PubMed1994

A randomized multicenter clinical trial comparing isosmolar icodextrin with hyperosmolar glucose solutions in CAPD. MIDAS Study Group. Multicenter Investigation of Icodextrin in Ambulatory Peritoneal Dialysis.

The osmotic effectiveness of a large molecular weight glucose polymer fraction (Icodextrin) as a novel "colloid" osmotic agent in peritoneal dialysis was established, but the long-term safety remained undetermined. A randomized, controlled multicenter investigation of Icodextrin in ambulatory peritoneal dialysis (MIDAS) was undertaken to evaluate the long-term safety and efficacy by comparing daily overnight (8 to 12 hr dwell) use of isosmolar Icodextrin (282 mOsm/kg) with conventional 1.36% (346 mOsm/kg) and 3.86% (484 mOsm/kg) glucose exchanges over six months. Two hundred and nine patients were randomized from 11 centers, with 106 allocated to receive Icodextrin (D) and 103 to remain on glucose (control group; C); 138 patients completed the six month study (71 C, 67 D). All patients were divided into weak (1.36%) or strong (3.86%) subgroups based on their use of glucose solutions overnight during the pretreatment baseline period. The mean (+/- SEM) overnight ultrafiltration (UF) with D was 3.5 times greater than 1.36% glucose at eight hours [527 +/- 36 vs. 150 +/- 47 ml; 95% confidence interval (CI) for the difference +257 to +497 ml; P < 0.0001] and 5.5 times greater at 12 hours (561 +/- 44 vs. 101 +/- 48 ml, 95% CI for the difference +329 to +590; P < 0.0001) and no different from that of 3.86% glucose at eight hours (510 +/- 48 vs. 448 +/- 60 ml, 95% CI for the difference -102 to +226 ml; P = 0.44) and at 12 hours (552 +/- 44 vs. 414 +/- 78 ml, 95% CI for the difference -47 to +325 ml; P = 0.06).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

PubMedDate not supplied

Serum disaccharides and osmolality in CCPD patients using icodextrin or glucose as daytime dwell.

OBJECTIVE: To evaluate the safety, efficacy, and biocompatibility of icodextrin- and glucose-containing dialysis fluid during continuous cycling peritoneal dialysis (CCPD), patients were treated for 2 years with either icodextrin- or glucose-containing dialysis fluid for their daytime dwell (14-15 hours). Prior to entry into the study, all patients used a standard glucose solution (Dianeal 1.36%, 2.27%, or 3.86%, Baxter, Utrecht, The Netherlands). DESIGN: Open, randomized, prospective, two-center study. SETTING: University hospital and teaching hospital. PATIENTS: Both established and patients new to CCPD were included. A life expectancy of more than 2 years, a stable clinical condition, and written informed consent were necessary before entry. Patients aged under 18, those with peritonitis in the previous month, and women of childbearing potential, unless taking adequate contraceptive precautions, were excluded. Thirty-eight patients entered the study, and 25 (13 glucose, 12 icodextrin) had a follow-up period of 12 months or longer in December 1996. MAIN OUTCOME MEASURES: Serum icodextrin metabolites: one to five glucose units (G1-G5), a high molecular weight fraction (G > 10), and total carbohydrate level, as well as a biochemical profile were determined every 3 months in combination with all other study variables. RESULTS: In icodextrin-treated patients, serum disaccharide (maltose) concentrations increased from 0.05 +/- 0.01 (mean +/- SEM) at baseline, to an average concentration in the follow-up visits of 1.14 +/- 0.13 mg/mL (p < 0.001). All icodextrin metabolites increased significantly from baseline, as illustrated by the serum total carbohydrate minus glucose levels: from 0.42 +/- 0.05 mg/mL to an average concentration in the follow-up visits of 5.04 +/- 0.49 mg/mL (p < 0.001). At the same time, serum sodium levels decreased from 138.1 +/- 0.7 mmol/L to an average concentration in the follow-up visits of 135.4 +/- 0.8 mmol/L (p < 0.05). However, after 12 months the serum sodium concentration increased nonsignificantly (NS) from baseline to 136.6 +/- 0.9 mmol/L, after an initial decrease. Serum osmolality increased significantly from baseline in icodextrin users at 9 and 12 months, but did not differ significantly from glucose users in any visit. In icodextrin-treated patients, the calculated serum osmolal gap increased significantly from 4.1 +/- 1.4 mOsm/kg to an average of 11.8 +/- 1.7 mOsm/kg (p < 0.01). The sum of the serum icodextrin metabolites in millimoles/liter equaled the increase in osmolal gap. Body weight increased in icodextrin users (71.9 +/- 2.8 kg to 77.8 +/- 3.0 kg; NS). Clinical adverse effects did not accompany these findings. Residual renal function remained stable during follow-up. CONCLUSIONS: The serum icodextrin metabolite levels in the present study increased markedly and were the same as those found previously in continuous ambulatory peritoneal dialysis patients treated with icodextrin, despite the longer dwell time for CCPD patients (14-16 hr versus 8-12 hr). The initial decrease in serum sodium concentration was followed by an increase to a concentration not different from baseline at 12 months. The pathophysiology of this finding is speculated. Calculated osmolal gap in icodextrin patients increased significantly (p < 0.01) at every follow-up visit, and could be explained by the serum icodextrin metabolite increase. We encountered no clinical side effects of the observed levels of icodextrin metabolites.

Adolescent↗

PubMed1999

Comparison of icodextrin and glucose solutions for the daytime dwell in automated peritoneal dialysis.

BACKGROUND: The sustained ultrafiltration achieved by icodextrin is more suited for the daytime dwell in automated peritoneal dialysis (APD) than glucose solutions. METHODS: Seventeen patients receiving APD underwent assessment using three different solutions for the daytime dwell: 2.27% glucose, 3.86% glucose and 7.5% icodextrin. Patients were then observed on icodextrin for a 6 month period. RESULTS: Daytime ultrafiltration was greater for 3.86% glucose (median 0.10, IQR 0.01 to 0.321) P<0.01 and icodextrin (median 0.26, IQR 0.14 to 0.361) P<0.001 than 2.27% glucose (median -0.19, IQR -0.54 to -0.081), with 3.86% glucose and icodextrin not being significantly different. Positive ultrafiltration occurred in 3/17 patients with 2.27% glucose, 13/17 patients with 3.86% glucose and 16/17 patients with icodextrin (chi2 P<0.0001). The difference in ultrafiltration of icodextrin and 3.86% glucose correlated with the 4 h dialysate/plasma creatinine ratio in a PET test (r = 0.51, P<0.05). Daytime Kt/V urea was greater for 3.86% glucose (median 0.27, IQR 0.20 to 0.48 per week, P<0.01) and icodextrin (median 0.31, IQR 0.27 to 0.49 per week, P<0.0001) than for 2.27% glucose (median 0.22, IQR 0.15 to 0.38 per week), with the difference between 3.86% glucose and icodextrin not reaching statistical significance (P = 0.06). Daytime creatinine clearance was greater for 3.86% glucose (median 10.2, IQR 6.9 to 13.61/week/1.73 m2, P<0.02) and icodextrin (median 12.1, IQR 9.3 to 15.71/week/1.73 m2, P<0.005) than for 2.27% glucose (median 8.8, IQR 4.9 to 11.91/week/1.73 m2). Daytime creatinine clearance was greater for icodextrin than for 3.86% glucose (P<0.005). The effects of icodextrin were sustained for the 6 month observation period. CONCLUSIONS: Icodextrin produced enhanced ultrafiltration and clearances compared with 2.27% glucose, without the exposure of the peritoneum to hypertonic glucose solutions.

Adult↗

PubMed1998

Icodextrin use in CCPD patients during peritonitis: ultrafiltration and serum disaccharide concentrations.

BACKGROUND AND METHODS: In a randomized study on the biocompatibility of icodextrin (I) versus glucose (G) in CCPD we used icodextrin or glucose for the long daytime dwell. During the night-time dwells glucose was used in all patients. In case of peritonitis icodextrin was continued. In all patients ultrafiltration (UF) was recorded and serum icodextrin metabolites were determined every 3 months and during peritonitis in I-users when available. RESULTS: Thirty-eight patients ( 19 G, 19 I) entered the study and suffered 30 peritonitis episodes (16 G, 14 I). During peritonitis (P), daytime dwell UF decreased significantly in G (P=0.001), but remained stable in I patients compared to non-peritonitis (NP) episodes. Total 24-h UF decreased in G (P=0.001) and in I patients (P=0.04), as the result of a decreased daytime UF and night-time UF, respectively. There was no difference in the used glucose concentrations during the P versus NP episodes. In five I-patients serum disaccharides increased from 0.05+/-0.01 to 1.26+/-0.23mg/ml during follow up. During peritonitis serum disaccharide concentrations did not increase further (1.47+/-0.24 mg/ml, P= 0.56). In I patients total carbohydrate minus glucose rose to 5.72 +/- 1.2 mg/ml during follow up, and to 6.63 +/- 1.04 mg/ml during peritonitis (P=0.7). These concentrations are comparable to CAPD patients despite the longer dwelltime in CCPD (8-10 versus 14-16 h, respectively). Adverse reactions attributable to icodextrin were not encountered. CONCLUSIONS: In contrast to glucose, icodextrin preserved the daytime dwell ultrafiltration during peritonitis. Serum icodextrin metabolites increased during icodextrin use, but remained stable during peritonitis. Adverse effects were not observed.

Blood Glucose↗

PubMed2000

Development of a novel glucose polymer solution (icodextrin) for adhesion prevention: pre-clinical studies.

Intra-abdominal adhesion formation causes significant post-operative morbidity. Controlled studies using animal models have been carried out to assess the tolerability and preventive efficacy of icodextrin solution (a biodegradable, biocompatible, glucose polymer). Reduction of adhesion formation was first evaluated in a rabbit double uterine horn model, applying 10-75 ml of 7.5 and 20%, or 50 ml of 2.5-20% icodextrin solution post-operatively. Significant increases in adhesion free sites (P < 0.005) were observed with volumes > or =25 ml, and at concentrations > or =4%. Efficacy of 50 ml 4 and 20% icodextrin was then evaluated both during and after surgery, demonstrating significant reductions in adhesion formation (P < 0. 002). In one study, intra- plus post-operative use of 4% icodextrin produced the greatest reduction of non-surgical site adhesions; in others, the post-operative effect was predominant. Post-surgical administration of 50 ml 4% icodextrin in a rabbit sidewall model also resulted in more adhesion-free animals, and a significant reduction (P < 0.001) in areas of adhesion formation and reformation. In a rat infection potentiation model, 4% icodextrin produced no difference in mortality, abscess formation or overall abscess score. These data suggest that 4% icodextrin offers a well-tolerated and effective means of reducing post-surgical adhesion formation.

Animals↗

PubMedDate not supplied

Icodextrin's effects on peritoneal transport.

OBJECTIVE: To give a survey of the principles of peritoneal fluid transport in general, followed by an analysis of the effects of icodextrin on the transport of fluid and solutes. DESIGN: A review of the literature and of data on the effects of icodextrin in continuous ambulatory peritoneal dialysis (CAPD) patients at the Academic Medical Center, Amsterdam. RESULTS: Icodextrin had no effect on the mass transfer area coefficients of low molecular weight solutes. Also no effect was found on the clearances of albumin and larger serum proteins. Due to convective transport, the clearance of beta 2-microglobulin was greater with icodextrin than with glucose solutions. Icodextrin was especially superior to glucose in the induction of net ultrafiltration during long dwells, during peritonitis, and in patients with ultrafiltration failure caused by a large effective peritoneal surface area. CONCLUSION: Icodextrin has no effect on the permeability characteristics of the peritoneal membrane, but increases convective flow through the small-pore system. As a result, the peritoneal clearance of beta 2-microglobulin is higher than with glucose-based solutions. Icodextrin is especially indicated for long dwells and in patients with impaired ultrafiltration caused by a large peritoneal surface area, leading to high transport rates of low molecular weight solutes.

Biological Transport↗

PubMed1997

Icodextrin instead of glucose during the daytime dwell in CCPD increases ultrafiltration and 24-h dialysate creatinine clearance.

BACKGROUND AND METHODS: Icodextrin 7.5% is an iso-osmolar, glucose polymer-containing peritoneal dialysis solution with an ultrafiltration potential similar to glucose 3.86%. We compared in an open, randomized, prospective study the ultrafiltration potential of icodextrin with that of glucose during the daytime dwell of 23 patients treated with automated peritoneal dialysis (CCPD). RESULTS: Daytime ultrafiltration volume and 24-h ultrafiltration volume increased significantly in icodextrin-treated patients (n = 11) at 3 and 6 months, allowing patients a less rigid fluid restriction or an adapted treatment schedule. This improved the patients' subjective well-being. Although ultrafiltration at 9 and 12 months also increased it did not reach statistical significance. Similar to the gain in ultrafiltration volume, 24-h dialysate creatinine clearance per 1.73 m2 (DCl/1.73 m2) and DCl/1.73 m2 per litre used dialysate (DCl/1.73 m2/l) increased in icodextrin-treated patients. DCl/1.73 m2/l per litre ultrafiltrate (DCl/1.73 m2/l/UF) did not increase. No side-effects of icodextrin were encountered, although serum disaccharide levels increased. CONCLUSION: Icodextrin enhances ultrafiltration during the daytime dwell in CCPD patients. As a result of an increased 24-h ultrafiltration volume, DCl/1.73 m2 and DCl/1.73 m2/l improve. DCl/1.73 m2/l/UF does not rise, which suggests that the increase in DCl/1.73 m2 and DCl/1.73 m2/l is caused by convective transport.

Creatinine↗

PubMed1997

Future clinical research with icodextrin-containing solutions.

Icodextrin-based solutions have been investigated for over ten years and are commercially available in some countries in Europe. Although many studies have been described using icodextrin, we believe that there are many interesting areas remaining for clinical research with icodextrin-based PD solutions. Included in these are the careful examination of the kinetics of icodextrin during the 14-16 hour daytime exchange in CCPD, new studies investigating fluid absorption during icodextrin exchanges, and finally, the potential use of icodextrin in an early start dialysis regime. We look forward to seeing the results from these very interesting studies.

Absorption↗

PubMedDate not supplied

A previously undescribed side effect of icodextrin: overestimation of glycemia by glucose analyzer.

OBJECTIVE: Serious discrepancies between glycemia measurements obtained with an Accutrend Sensor (Boehringer Mannheim GmbH, Mannheim, Germany) type analyzer (based on a glucose dehydrogenase enzymatic reaction) and measurements obtained in the laboratory by a reference method (hexokinase) have been found in an insulin-requiring, diabetic, continuous ambulatory peritoneal dialysis (CAPD) patient treated with icodextrin 7.5% (Extraneal; Baxter Healthcare SA, Castlebar, Ireland), a new osmotic agent for peritoneal dialysis. We therefore investigated the respective role of the Analyzer and of the glucose polymer in this hitherto undescribed problem. DESIGN: Glycemia was measured simultaneously on venous blood using a reference laboratory technique, and on capillary blood using the Accutrend Sensor glucose analyzer in three groups of CAPD patients: 6 patients on Extraneal for at least 1 week, 6 patients receiving their first Extraneal exchange, and 8 patients never exposed to Extraneal. In the first group of patients, glycemia was also measured with another analyzer (Glucocard; Menarini Diagnostics, Firenze, Italy) using a different enzymatic reaction (glucose oxidase). In a separate study, whole blood of a normal subject was spiked with concentrated solutions of glucose and icodextrin and some of its metabolites (maltose, maltotriose, maltopentaose). Once again, comparative measurements of glycemia were performed with the Accutrend Sensor, with two other kits using a glucose dehydrogenase enzyme reaction, and with the hexokinase reference method. RESULTS: In 6 CAPD patients treated with once-daily exchanges with Extraneal for a minimum of 7 consecutive days, we confirmed overestimation of glycemia by the Accutrend Sensor of 65 +/- 26 mg/dL compared to reference values (p < 0.01), and of 69 +/- 25 mg/dL (p < 0.001) compared to measurements obtained with the Glucocard monitor. In 6 other CAPD patients studied at the end of one single icodextrin exchange, overestimation of 61 +/- 11 mg/dL was already present (p < 0.001). On the other hand, in 8 CAPD patients never treated with icodextrin, there was no discrepancy between the Accutrend Sensor readings and reference values. The measurements in spiked blood confirmed that only the Accutrend Sensor overestimates glycemia in the presence of maltose and glucose polymers. The overestimation decreased as the molecular size of the saccharides added to blood increased. There was no overestimation when other kits using a dehydrogenase enzyme were tested. CONCLUSION: The overestimation observed is probably related to the presence of oligosaccharides (mainly maltose), derivatives of glucose polymers present in Extraneal and absorbed via the peritoneal route, in the blood of patients treated with icodextrin. The glucose dehydrogenase characterizing the Accutrend Sensor, an enzyme of the pyrroloquinolinequinone class, very likely reacts with the free reducing group of the glucose molecule located at the end of each saccharide chain. This would not be the case for the Glucocard monitor using glucose oxidase, for other kits using glucose dehydrogenase, and for the reference method based on hexokinase. The Accutrend Sensor type of analyzers are therefore not suitable for regular monitoring of glycemia in diabetic PD patients treated with icodextrin.

Aged↗

PubMed2000

Effects of icodextrin in automated peritoneal dialysis on blood pressure and bioelectrical impedance analysis.

BACKGROUND: Glucose absorption from glucose-based dialysis fluids limits ultrafiltration from the daytime dwell in automated peritoneal dialysis (APD). Icodextrin may allow greater ultrafiltration during the daytime period in APD, enhancing fluid control. METHODS: A 7.5% icodextrin dialysate was compared with a 2. 27% glucose dialysate for the daytime dwell in 14 subjects on APD. Blood pressure, weight and body water compartments estimated by multifrequency bioelectrical impedance (MFBIA) were determined in subjects using 2.27% glucose as the daytime dwell and then repeated 1 month after switching to icodextrin. RESULTS: Icodextrin resulted in symptomatic hypotension requiring reduction of antihypertensive medication in six of the 14 patients. Despite this reduction in treatment, systolic blood pressure fell from 142.4 (23.9) mmHg to 122.9 (17.7) mmHg, P<0.005, and diastolic blood pressure tended to fall from 82.8 (9.8) mmHg to 76.8 (10.1) mmHg, P=0.075. Change in systolic blood pressure significantly correlated with changes in weight (r=0.62, P<0.05) and MFBIA estimates of total body water (TBW) (r=0.56, P<0.05), extracellular water (ECW) (r=0.79, P<0.002), extra/intracellular water ratio (ECW/ICW) (r=0.72, P<0.01) and derived resistances R(ecf) of ECW (r=-0.69, P<0.01) and R(inf) of TBW (r=-0.66, P<0.02). Changes in diastolic blood pressure significantly correlated with changes in ECW (r=0.64, P<0.02) and ECW/ICW ratio (r=0.58, P<0.05), and almost significantly with R(ecf) (r=-0.51, P=0.08) and R(inf) (r=-0.52, P=0.07) estimated by MFBIA, but not with changes in weight or TBW. CONCLUSIONS: Use of icodextrin for the daytime dwell in APD results in improved fluid balance and blood pressure control compared with 2.27% glucose. MFBIA detected clinically important changes in fluid content in these patients.

Adult↗

PubMed1998

Maltose and isomaltose in uremic plasma following icodextrin administration.

The presence of mixed disaccharides (maltose and isomaltose) in plasma from uremic patients has been previously investigated using gel-permeation chromatography. However, this method is unable to separate maltose (linked alpha-1-4) from isomaltose (linked alpha-1-6). We describe an alternative method using high-performance anion-exchange chromatography with pulsed amperometric detection (HPAE-PAD) for the direct determination of maltose and isomaltose in uremic plasma. We measured maltose and isomaltose using HPAE-PAD in 6 normal subjects and in 15 uremic patients before and after once-daily icodextrin administration for at least 4 weeks. Both maltose and isomaltose were below limits of detection (< 1.0 mg/L) in plasma from normal controls. Patients with end-stage renal disease treated by continuous ambulatory peritoneal dialysis had elevated levels of isomaltose (23.6 +/- 8.3 mg/L) but low levels of maltose (< 3.0 mg/L). Treatment with icodextrin resulted in elevated plasma levels of maltose (range: 500-1600 mg/L), while levels of isomaltose declined to 9.8 +/- 5.2 mg/L (P < 0.0001 vs. baseline levels). We conclude that isomaltose (not maltose) is the primary disaccharide isomer that is elevated in the plasma of uremic patients, whereas maltose is the primary disaccharide isomer that is elevated following icodextrin administration. Furthermore, icodextrin administration results in an apparent reduction of isomaltose. Additional investigation will be required to address the mechanism for the reduction of isomaltose in patients treated by icodextrin.

Chromatography, High Pressure Liquid↗

PubMed1999

Failure of icodextrin to provide adequate ultrafiltration in continuous ambulatory peritoneal dialysis patients.

Icodextrin, a starch-derived glucose polymer with an average molecular weight of 20,000 D, has been developed partly as a response to some of the disadvantages of dextrose. It has been suggested that icodextrin solutions are able to provide sustained ultrafiltration (UF) over long dwell times of 8-12 hours in continuous ambulatory peritoneal dialysis (CAPD). In this paper we describe three patients on CAPD: 2 males and 1 female aged 60, 67, and 58 years respectively, duration on CAPD 47, 60, and 15 months respectively. All of these patients, who were categorized as high transporters according to peritoneal equilibration test (PET) results, presented early signs of ultrafiltration loss with no evidence of peritoneal inflammation. Icodextrin solution was used in a single nightly exchange with 10-12 hours' dwell, for a period of 5-30 days. In all of these cases, icodextrin solution failed to provide adequate ultrafiltration and the patients returned to the previously used regime of five daily hypertonic exchanges of 3.86% glucose concentration. Although these negative results were not clearly explained, we report these three cases because they exemplify some limitations of icodextrin solution to provide adequate ultrafiltration, at least in a small number of CAPD patients.

Aged↗

PubMed1999

Lack of interference of icodextrin on creatinine measurements.

Glucose has been reported to interfere in the analysis of creatinine by the Jaffe method. The potential interference of icodextrin and its primary metabolites (maltose, maltotriose, maltotetraose) on creatinine measurements has not previously been addressed. We evaluated the potential interference of icodextrin and its metabolites at various concentrations using both the Jaffe and Creatinine Plus methods. Interference was determined in samples containing 0.6-20 mg/dL creatinine in saline solution or in plasma (n = 6), and in dialysate samples (n = 6) spiked with icodextrin, maltose, maltotriose, and maltotetraose at concentrations up to twofold the level found in plasma and dialysate from patients treated using icodextrin. Results confirm that no interference occurs when using either the colorimetric Jaffe method or the enzymatic Creatinine Plus method at levels up to 65 g/L icodextrin, 2 g/L maltose, 2 g/L maltotriose, and 1 g/L maltotetraose, levels representing worst-case clinical concentrations. In addition, our results confirm that comparable values can be obtained using either the Jaffe or the Creatinine Plus method for the analysis of creatinine in uremic plasma and in dialysate samples.

Creatinine↗

PubMedDate not supplied

Icodextrin: overview of clinical experience.

OBJECTIVE: To review all clinical studies and experience gained with icodextrin to date; primarily its use in peritoneal dialysis in patients with end-stage renal failure, but also its use as an intraperitoneal vehicle. DATA SOURCES: Peer-reviewed original research articles in the literature; abstracts from international scientific meetings; data generated from the compassionate use programme. STUDY SELECTION: All published studies to date are included, some 10-20 studies being included in this review. DATA EXTRACTION: Data have not been specifically extracted from studies; results have been described in the context of overall experience. RESULTS: Over ten years of clinical experience with icodextrin have now been accumulated, in both continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD). A small number of patients have received icodextrin for over five years, with no loss of effect. Icodextrin produces sustained ultrafiltration over long dwells while being iso-osmolar, by the process of colloid osmosis. CONCLUSIONS: Icodextrin represents the first viable alternative osmotic agent to glucose, for use in solutions for peritoneal dialysis. It also has a potential use as a vehicle solution for intraperitoneal drug delivery.

Dialysis Solutions↗

PubMed1998

Icodextrin provides long dwell peritoneal dialysis and maintenance of intraperitoneal volume.

Icodextrin 7.5% is an isosmolar solution for once-daily use in peritoneal dialysis for patients with end-stage renal failure (ESRF). It produces substantial ultrafiltration (UF), performing best over longer dwells of 8-12 h in continuous ambulatory peritoneal dialysis (CAPD) patients, and up to 16 h in automated peritoneal dialysis (APD) patients. Subsequent use in other clinical areas (ultrafiltration failure) and normal postmarketing clinical experience has established its tolerability and safety profiles; a small number of patients, including those with diabetes, have now received icodextrin for up to 6 years. Icodextrin's ability to maintain intraperitoneal volume over many hours has led to its undergoing development as an intraperitoneal drug delivery system for targeted regional delivery of anticancer drugs and lymphatic delivery of anti-HIV treatment. Isosmolar icodextrin 7.5% solution represents the first major advance in the treatment of ESRF by peritoneal dialysis since the development of CAPD using glucose-based solutions 20 years ago.

Dialysis Solutions↗

PubMed1998

Icodextrin with nitroprusside increases ultrafiltration and peritoneal transport during long CAPD dwells.

Addition of the nitric oxide (NO) donor nitroprusside to 1.36% glucose dialysate enlarges the effective peritoneal surface area during four-hour dwells. The theoretical positive effect on ultrafiltration is, however, counteracted by an increase in glucose absorption. The absorption of the glucose polymer icodextrin is much lower in comparison with glucose-based dialysis solutions, due to its high molecular weight. In the present study 7.5% icodextrin dialysis solution with and without the addition of 4.5 mg/liter nitroprusside was studied during eight-hour CAPD dwells. Two Standard Peritoneal permeability Analyses, adapted for eight-hour dwells, were performed in 10 stable CAPD patients. Nitrate and cGMP were measured as parameters of NO synthesis. The transcapillary ultrafiltration increased in a linear way with icodextrin (ICO) and was even higher after the addition of nitroprusside (NP): 666 (ICO) versus 834 (NP) ml/8 hr, P = 0.03. The effective lymphatic absorption rate was not different. The resulting net ultrafiltration increased with nitroprusside: 344 (ICO) versus 540 (NP) ml/8 hr, P < 0.01. The mass transfer area coefficient of urea increased 15% and that of creatinine 26% with nitroprusside, consistent with the expected enlargement of the vascular peritoneal surface area. The increase in protein clearances was more pronounced the larger the protein: beta 2-microglobulin 19%, albumin 47%, IgG 63% and alpha 2-macroglobulin 95%. Dialysate/plasma (D/P) ratios of nitrate were not higher than the expected values on the basis of its molecular weight (P < 0.001). They increased 19% with nitroprusside. Also, the D/P ratio cyclic guanosine monophosphate (cGMP) after four hours increased with nitroprusside (0.39, range 0.13 to 0.55 ICO, and 0.82, range 0.36 to 1.39 NP, P = 0.01). With nitroprusside the D/P ratio cGMP was higher than expected after four and eight hours (P < 0.001). This points to local generation of NO after addition of nitroprusside. The nitroprusside induced increase in the mass transfer area coefficients (MTAC) of creatinine and in the ultrafiltration caused an increase in the creatinine clearance from 4.2 ml/min to 5.0 ml/min during the eight-hour dwell. This means that nitroprusside adds 3 liters/week to the peritoneal clearance of creatinine. The adequacy of peritoneal dialysis can therefore be improved by the addition of nitroprusside to 7.5% icodextrin, used for the long exchange.

Adult↗

PubMed1999

Effect of icodextrin peritoneal dialysis solution on cell proliferation in vitro.

Peritoneal dialysis solutions containing icodextrin are ideal for providing sustained ultrafiltration during long dwells, and they have replaced high glucose for long dwells in some patients. The biocompatibility of these solutions, especially in regard to glucose degradation products, has not been studied in depth. The object of this study was to compare the effects of commercially available dextrose-containing dialysis solutions to those of icodextrin-containing solutions on fibroblast proliferation in vitro. We measured the effect of solutions on cell growth by exposing murine fibroblasts to pH-adjusted test solutions mixed with culture medium, and by comparing cell growth to growth in culture medium only. No statistical difference was observed in the growth of cells exposed to heat-sterilized Extraneal [7.5% icodextrin (Baxter Healthcare, Deerfield, Illinois, U.S.A.)], heat-sterilized Dianeal [1.5% dextrose (Baxter Healthcare)], or filter-sterilized Dianeal [4.25% dextrose (Baxter Healthcare]. Also, no difference was observed in the growth of fibroblasts exposed to heat-sterilized Extraneal or to filter-sterilized Extraneal, but heat-sterilized Dianeal [4.25% dextrose (Baxter Healthcare)] caused a significant reduction in cell growth. Glucose degradation products (GDPs) are known to contribute to reduced cell growth in vitro. Extraneal had lower levels of the GDP acetaldehyde compared to Dianeal (2.5% or 4.25% dextrose). The results demonstrate enhanced in vitro biocompatibility characteristics for Extraneal, possibly related to low GDP levels in Extraneal.

Animals↗