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PubMed2000

Assessment of the effectiveness, safety, and biocompatibility of icodextrin in automated peritoneal dialysis. The Dextrin in APD in Amsterdam (DIANA) Group.

OBJECTIVE: Our study assessed the efficacy, safety, and biocompatibility of icodextrin (I) solution compared to glucose (G) solution as the daytime dwell in continuous cycling peritoneal dialysis (CCPD). DESIGN: In a randomized, open, prospective, parallel group study of two year's duration, either I or G was used for the long daytime dwell in CCPD patients. METHOD: The study was carried out in a university hospital and teaching hospital. Established CCPD patients and patients new to the modality were both included. Clinic visits were made at three-month intervals. In all patients, clinical data were gathered; ultrafiltration (UF) was recorded; and serum, urine, and dialysate samples and effluents were collected. Peritoneal defense characteristics and mesothelial markers were determined. Every six months, peritoneal kinetics studies were performed, and serum samples for icodextrin metabolites were taken. RESULTS: Thirty-eight patients (19 G, 19 I) started the study. The median follow-up was 16 months and 17 months respectively (range: 0.5 - 26 months and 3 - 26 months, respectively). Daytime UF volumes increased significantly (p < 0.001), and 24-hour UF tended to increase from baseline in the I group. Dialysate creatinine clearance increased non significantly in both groups over time. In I patients, serum disaccharides (maltose) concentration increased from 0.05+/-0.01 mg/mL [mean+/- standard error of mean (SEM)] at baseline, to an average concentration in the follow-up visits of 1.15+/- 0.04 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 135.9 +/- 0.8 mmol/L (p < 0.050). At 12 months, the serum sodium concentration increased to a non significant difference from baseline. Serum osmolality increased, but did not differ significantly from G users at any visit. During peritonitis (P), daytime dwell UF decreased significantly compared to non peritonitis (NP) episodes in G patients (p < 0.0 01), but remained stable in I patients. Total 24-hour UF also decreased in G patients (p < 0.001), but not in I patients. In these I patients, serum disaccharides increased from 0.05 +/- 0.01 mg/mL to 1.26 +/- 0.2 mg/mL during follow-up. During peritonitis, serum disaccharides concentration did not increase further (1.47 +/- 0.2 mg/mL, p= 0.56). Thirty P episodes occurred during follow-up: 16 in G patients and 14 in I patients (1 per 17.6 months and 1 per 21.9 months, respectively.) After one year, absolute number and percentage of effluent peritoneal macrophages (PM phi s) were significantly higher in I patients than in G patients. The difference in percentage persisted after two years. The phagocytic capacity of PM phi s decreased over time, resulting in a borderline significant difference for coagulase-negative staphylococci phagocytosis (p=0.005) and a significant difference for E. coli phagocytosis (p <0.05) in favor of I patients. PM phi oxidative metabolism, PM phi cytokine production, and effluent opsonic capacity remained stable over time with no difference between the groups. Mass transfer area coefficients (MTACs) and clearances were stable and appeared unaffected by G or I treatment. Effluent cancer antigen 125 (CA125) was stable in G users and tended to decrease in I users. Effluent interleukin-8 (IL-8), carboxy-terminal propeptide of type I procollagen (PICP ), and amino-terminal propeptide of type III procollagen (PIIINP) did not change over time and did not differ between the groups. CONCLUSION: The use of I for the long daytime dwell in CCPD led to an increase in total UF of at least 261 mL per day, which was maintained over at least 24 months. During I treatment, serum I metabolites increased significantly and serum sodium concentrations decreased initially. As a result, serum osmolality increased slightly. Clinical adverse effects did not accompany these findings. The UF gain in the I patients was even higher during P, without a

Adult↗
PubMedDate not supplied

Icodextrin effluent leads to a greater proliferation than glucose effluent of human mesothelial cells studied ex vivo.

OBJECTIVE: To compare the effect of glucose (Glu) and icodextrin (Ico) dialysate on in vitro culture of mesothelial cells (MC) from peritoneal dialysis (PD) patients. DESIGN: Prospective, controlled comparative study on the effects of two PD solutions. SETTING: A tertiary-care public university hospital. PATIENTS: Sixteen PD patients regularly using Glu dialysate were asked to collect an 8-hour dwell peritoneal effluent on 2 different days, with an interval shorter than 7 days. In the first collection, 2.27% Glu solution and in the last, 7.5% Ico solution was infused. Human MC were isolated from the nocturnal peritoneal effluent bags and grown ex vivo. MAIN OUTCOME MEASURES: Mesothelial cell proliferative capacity ex vivo. RESULTS: Mesothelial cells were present in all patient dialysates except that of a single patient's Glu dialysate. The number of MC drained was similar with both solutions. After the initial culture reached confluence, MC were identified in 14 and 12 patients receiving Ico and Glu, respectively. However, in 1 patient using Ico and in 2 using Glu, the MC count at this stage was so low that further subculture could not be performed. Cells from Ico-derived solutions exhibited a higher degree of proliferation than cells from Glu-derived solutions. The morphology of MC was also different. Cells from drained effluent were typical in 11 patients using Glu solution in contrast with 14 patients using Ico. At confluence, the percentages of typical appearance were 50% and 92.9% (p < 0.05) in Glu and Ico respectively. CONCLUSIONS: Mesothelial cells taken from icodextrin effluent show a greater proliferation ex vivo than those taken from glucose effluent.

Cell Division↗
PubMedDate not supplied

Glycation and advanced glycation end-product formation with icodextrin and dextrose.

OBJECTIVE: To review protein glycation and advanced glycation end-product formation with particular reference to its occurrence in the peritoneum following exposure to peritoneal dialysis fluid. DATA SOURCES: Articles identified through searches on MEDLINE and BIDS and references cited therein. STUDY SELECTION: Studies on the interaction of amino groups with glucose, maltose and glucose polymers. Studies containing evidence of peritoneal advanced glycation end-product formation. DATA EXTRACTION: Studies evaluated as to whether they are in vivo, ex vivo or in vitro under non-physiological or physiological conditions. RESULTS: Protein glycation is slower with maltose and glucose polymers than with equimolar glucose. Advanced glycation end-product formation occurs with all three sugars, but to a greater extent after standard heat sterilization of dialysis fluid and to a lesser extent in heat sterilized fluids containing icodextrin rather than glucose. Glucose degradation products significantly contribute to protein-linked advanced glycation end-product-like fluorescence. Histology and immunohistochemistry demonstrate diabetiform changes and advanced glycation end-products in the peritoneal membrane following exposure to glucose-containing peritoneal dialysis fluids. Their presence is likely to be detrimental to peritoneal function and may contribute to loss of ultrafiltration. CONCLUSIONS: Advanced glycation end-product formation is lower but still significant with heat sterilized peritoneal dialysis fluid containing icodextrin than with glucose. More research is needed to investigate the interaction of glucose degradation products and glucose polymers with proteins and the possible consequences of advanced glycation end-product formation on peritoneal function.

Dialysis Solutions↗
PubMed2000

Computer simulations of ultrafiltration profiles for an icodextrin-based peritoneal fluid in CAPD.

BACKGROUND: The three-pore model of peritoneal transport has the ability to predict ultrafiltration (UF) profiles rather accurately, even when high molecular weight (MW) solutes are employed as osmotic agents in continuous ambulatory peritoneal dialysis (CAPD). In the present simulations, we wanted to assess, for various theoretical perturbations, the UF properties of a peritoneal dialysis (PD) solution with an osmotic agent having an average MW of 20 kD and a "number average MW" of 6.2 kD, which is similar to that of icodextrin (ICO). METHODS: For a PD solution containing a completely monodispersed 20 kD MW osmotic agent, the degree of UF modeled is much higher than that reported for ICO. Hence, to model the behavior of ICO, we subdivided the ICO molecules into eight or more different MW size fractions. For simulations using six or eight subfractions, we obtained an excellent fit of simulated to reported UF data. More dispersed solutions produced UF profiles similar to that with eight fractions. RESULTS: A 2.05 L 7.5% ICO PD solution, despite being slightly hypotonic, yielded a UF volume of nearly 600 mL in 12 hours, modeled for patients not previously exposed for ICO. After nine hours, the UF volume exceeded that produced by 3.86% glucose. The UF rate and volumes increased in proportion to (1) the ICO concentration, (2) the peritoneal surface area, and (3) the peritoneal UF coefficient, but was almost insensitive to increases in the instilled fluid volume. Simulated for patients previously exposed to ICO, having steady-state plasma concentrations of ICO degradation products, the predicted UF volume at 12 hours was reduced to approximately 400 mL. CONCLUSION: Employing the three-pore model of peritoneal transport and taking into account the polydispersed nature of ICO, it was possible to accurately computer simulate the UF profiles of ICO in accordance with reported data. The simulations suggest an advantage of using ICO in patients with type I UF failure, where UF with a high-MW osmotic agent will exceed that seen in patients not showing UF failure who are on glucose-based PD solutions.

Absorption↗
PubMed2000

Ultrafiltration with icodextrins in continuous ambulatory peritoneal dialysis and automated peritoneal dialysis.

Icodextrins (Icos) produce constant linear ultrafiltration (UF). This effect allows Icos to replace glucose during long dwells in continuous ambulatory peritoneal dialysis [CAPD (nighttime)] and automated peritoneal dialysis [APD (daytime)]. However, the effectiveness of Icos in producing UF (IcoUF) is limited by lymphatic reabsorption, whose extent depends partly on posture and physical activity. This paper aims to assess whether the difference in posture and physical activity between daytime dwells in APD and nighttime dwells in CAPD affects IcoUF. Patients undergoing first treatment were retrospectively examined. Ten patients were on CAPD [4 males, 6 females; average age, 73.0 +/- 13.4 years; body surface area (BSA), 1.63 +/- 0.21 m2; total volume per day, 5.6 +/- 1.9 L], and ten were on APD (7 males, 3 females; average age, 67.7 +/- 9.8; BSA, 1.75 +/- 0.22 m2; total volume per night, 10.5 +/- 0.9 L). Ultrafiltration was assessed for seven consecutive days preceding a peritoneal equilibration test (PET) and collection of diuresis. In both groups, 3 patients had no diuresis, and the difference between CAPD and APD was not significant (625 +/- 762 mL vs 780 +/- 878 mL). Moreover, no significant difference was seen in 4-hour dialysate-to-plasma creatinine (D/P) between CAPD (0.65 +/- 0.12) and APD (0.64 +/- 0.05). Dwell times with Icos were shorter in CAPD than in APD (11.5 +/- 1.8 hours vs 14.8 +/- 0.5 hours, p < 0.0005), but the fill volume was not significantly different (1760 +/- 286 mL vs 1790 +/- 249 mL). Water excretion owing to diuresis and dialysis [total water excretion (TWE): 1619 +/- 497 mL CAPD vs 1762 +/- 736 mL APD] and dialytic UF (363 +/- 443 mL CAPD vs 748 +/- 479 mL APD), which is not linked to Icos, were not significantly different between the two groups. The IcoUF and the percentage of IcoUF to TWE were significantly higher in CAPD compared to APD [631 +/- 253 mL (44% +/- 27%) vs 234 +/- 215 mL (19% +/- 19%), p < 0.001 (p < 0.05)]. In conclusion, an upright posture and physical activity seem to produce less IcoUF in APD despite the longer dwell. These factors could, indeed, produce greater intraperitoneal pressure, resulting in increased lymphatic reabsorption during a daytime dwell.

Aged↗
PubMedDate not supplied

The relationship between ultrafiltrate volume with icodextrin and peritoneal transport pattern according to the peritoneal equilibration test.

OBJECTIVE: To establish a relationship between peritoneal transport membrane pattern, analyzed by the peritoneal equilibration test (PET), and drained volume using icodextrin (7.5% Ico) and glucose (3.86% Glu) solutions. DESIGN: Thirty peritoneal dialysis patients were submitted to a standard 4-hour PET and divided into 4 transport categories based on dialysate-to-plasma ratio of creatinine (D/Pcr) and dialysate ratio of glucose at 4 and zero hours of the dwell (D4/D0). Patients were asked to perform exchanges for 2 consecutive nights in 10-hour dwells (2 L 3.86% Glu solution on the first night, and 2 L 7.5% Ico solution on the second night). The drained volume was measured and dialysate samples from the overnight exchanges were obtained for beta2-microglobulin (B2M) levels. RESULTS: PET classification using D/Pcr showed that 46.6% of the patients were high and high-average transporters, or 23.3% when D4/D0 was used. In spite of this difference, both methods showed significant correlation (p = 0.0001, r = 0.862). The mean drained volumes were similar for both solutions (for 3.86% Glu, 2696 +/- 369 mL; for 7.5% Ico, 2654 +/- 424 mL). The high and high-average transport patients classified by D4/D0 achieved a higher ultrafiltration with 7.5% Ico than with 3.86% Glu (p = 0.0235). When classified by D/Pcr, the difference was not significant (p = 0.2243). In the low and low-average transport patients classified by D/Pcr, we observed a significantly lower ultrafiltration when 7.5% Ico was used compared to 3.86% Glu solution (p = 0.0197). Using D4/D0, we saw a tendency toward lower ultrafiltration (p = 0.0719) in the same group. We then correlated the PET results and the difference between drained volume with 7.5% Ico and 3.86% Glu solution [deltaV (I-G)]. We found a significant negative correlation between D4/D0 and deltaV (I-G) (p = 0.002, r = -0.5390), and a positive correlation between D/Pcr and deltaV (I-G) (p = 0.005, r = 0.4932). The levels of B2M obtained with 7.5% Ico were higher than those obtained with 3.86% Glu solution (for 7.5% Ico, 9.47 +/- 6.71 microg/vol; for 3.86% Glu, 7.29 +/- 4.91 microg/vol; p = 0.004). Furthermore, we found significant correlation between the total amount of B2M obtained with 7.5% Ico solution and D4/D0 (p < 0.0001, r = -0.4493), and D/Pcr (p < 0.0001, r = 0.5431). CONCLUSION: Mean drained volume was similar between the two solution groups. High transporters, as defined by D4/D0, achieved higher ultrafiltration with 7.5% Ico than with 3.86% Glu solution. This is most likely due to the higher number of small pores in the peritoneal membrane. Low transporters, as classified by D/Pcr, achieved lower ultrafiltration with 7.5% Ico than with 3.86% Glu solution. The deltaV (I-G) and the PET results showed significant correlation, confirming that high transporters have a higher ultrafiltration volume with 7.5% Ico. The total B2M mass obtained with 7.5% Ico was greater than with 3.86% Glu solution and significantly higher in the high transport patients, indicating a larger number of small pores. Thus, the deltaV (I-G) could give us an idea of the peritoneal transport pattern in peritoneal dialysis patients.

Adult↗
PubMed1997

New principles, better practices, and clearer perceptions in intraperitoneal chemotherapy: clinical experience using icodextrin 20 as a carrier solution.

The rationale for using intraperitoneal chemotherapy is based on three phenomena: certain types of tumor are confined to the abdominal cavity for many years; the ability to deliver the drug directly to the surface of tumor deposits; the pharmacological advantage of attaining high local concentrations of the drug within the cavity. Current techniques of intraperitoneal chemotherapy do not use a specially designed carrier solution, which greatly restricts flexibility and does not permit continuous ambulatory intraperitoneal chemotherapy necessary for optimal use of cell cycle-specific antitumor agents. Using icodextrin 20 as a carrier solution containing 50% of the dose of 5-fluorouracil in a 24-hour dwell, simultaneously with a 24-hour elastomeric infusor device containing 50% of the dose, we have succeeded in carrying out continuous ambulatory intraperitoneal chemotherapy, 5 days out of 7 for up to 12 weeks, exposing the peritoneal contents to drug concentrations a thousand-fold greater than attained in the serum in a Phase I clinical trial. These studies have for the first time demonstrated that it is possible to expose continuously for long periods intraperitoneal tumor deposits to sustained high levels of cell cycle-specific cytotoxic agents.

Antineoplastic Agents↗
PubMed1994

The use of glucose polymer (icodextrin) in peritoneal dialysis: an overview.

The osmotic effectiveness of glucose polymer is now well established. The relative inertness of this macromolecular compound has been the key factor in its success as the first "colloid" osmotic agent in clinical use. In its present form it sustains ultrafiltration for up to 12 hours, and a daily overnight use would obviate the need for hypertonic exchanges, especially 3.86% glucose. In addition, it could be used in automated peritoneal dialysis regimens to enhance ultrafiltration and solute clearance during the daytime. Preliminary reports also indicate that it is beneficial in diabetic patients and in some patients who have lost ultrafiltration. Although systemic accumulation of glucose polymer breakdown products occurs, it reaches steady-state levels quickly (within 2 weeks) and remains stable throughout the duration of polymer use. In the long-term study these levels of maltose and oligosaccharides over 2.5 years represent the longest exposure of these substances in uremic patients without any clinical or metabolic adverse effects and provides important evidence of its safety. Future work based on ongoing studies suggests that a family of physiological solutions ("bimodal" preparations in iso-osmolar combination) could be available, and the individual's dialysis prescription could be tailored to take into account the ultrafiltration and metabolic needs. Icodextrin will be a key component of such solutions.

Dialysis Solutions↗