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Post-marketing surveillance of immediate allergic reactions: polygeline-based versus polygeline-free pediatric TBE vaccine.

Scattered cases of immediate allergic reactions occurred in the nineties after widespread use of the original (polygeline-based) pediatric tick-borne encephalitis (TBE) vaccine and were reported to Pharmacovigilance, Chiron Vaccines. Although, still indicating a very rare frequency of about two cases per 100,000 doses sold, the benefit/risk assessment resulted in its withdrawal from the market in early 1998. An intensive evaluation revealed that polygeline used as a vaccine stabilizer was the most probable cause of the reported allergic reactions. Consequently, an improved pediatric TBE vaccine, free of polygeline and other protein-derived vaccine stabilizers, was developed. A post-marketing surveillance analysis covering the first two vaccination seasons after the introduction of this new pediatric TBE vaccine in early 2002 reveals a very low reporting rate of immediate allergic reactions post immunization (within the range as noted for other widely used vaccines for childhood immunization), i.e., 0.08-0.24 cases per 100,000 doses sold depending on case definition and medical assessment. In conclusion, this analysis provides post-marketing surveillance evidence that the change in the vaccine formulation, with regards to the potential risk of immediate allergic reactions, has led to an intended improvement in the vaccine's safety profile.

Adverse Drug Reaction Reporting Systems↗

Dextran 40 (Rheomacrodex) or Polygeline (Haemaccel) as an epidural patch for post dural puncture headache: a neurotoxicity study in a rat model of Dextran 40 and Polygeline injected intrathecally.

BACKGROUND AND OBJECTIVE: Although an epidural autologous blood patch is considered the most effective treatment for post dural puncture headache, which sometimes occurs following spinal or inadvertent spinal anaesthesia, there remains a need for alternative materials for epidural patches. We investigated the potential neurotoxicity of Dextran 40 (Rheomacrodex) and Polygeline (Haemaccel) used for this purpose in a rat model. METHODS: Repeated boluses of 10% Dextran 40, 3.5% Polygeline or 0.9% saline were injected intrathecally over a period of 1 month in three groups of rats. RESULTS: No behavioural or clinical derangements were observed in any of the three groups during this period. After sacrifice of the animals at the end of the experiment, no significant differences in the histopathological appearances of the spinal cords in the three groups were observed. No toxic effects diminishing viability of spinal cord cells were evident. Similarly, viability of renal, hepatic and peripheral blood mononuclear cells remained unaffected (98% +/- 2%). CONCLUSIONS: No deleterious effects, clinical or cellular, were evident in this rat model when Dextran 40 or Polygeline were injected intrathecally. Thus, both substances can be considered as possible alternative materials for epidural patches.

Animals↗

Retention and distribution of polygeline (Haemaccel) in the rat.

The plasma substitute polygeline (Haemaccel registered) contains a large fraction of molecules sufficiently small to cross the capillary and glomerular membranes. Plasma volume expansion, tissue extravasation and renal elimination of this artificial colloid were quantified using 125I-labelled polygeline molecules. In pentobarbital anaesthetized rats, either 10 ml 3.5% polygeline (n = 8) or 10 ml 0.9% saline (n = 8) was infused intravenously over 60 min. The plasma volume was assessed by the 3 min distribution volume for I-albumin and the plasma volume changes over time were calculated from erythrocyte volume fractions. The plasma volume increased by 4.6 (2.0) ml (mean (SD)) at the end of the Haemaccel infusion compared with 2.1 (1.8) ml after the saline infusion (P = 0.02). One hour later the increase was 2.4 (1.5) and 1.6 (1.0) ml respectively, not significantly different (P = 0.20). Extravasation of labelled polygeline was greatest in the kidney, possibly due to cellular uptake. Skin and skeletal muscle contained 4-5 times more polygeline than could be attributed to intravascular radioactivity, but still uptake in these tissues did not reach one percent of the amount injected. Following a 60 min infusion and a 60 min interval, 23 (4)% of the polygeline was recovered intravascularly, 43 (9)% had been excreted in urine, leaving 33% to other compartments. Thus, more polygeline was distributed to the interstitium than remained in the circulation. This calls for further investigations into the handling and effect of polygeline in this extravascular compartment.

Animals↗

Polygeline.

Polygeline is a polymer of urea and polypeptides derived from degraded gelatin. The mean molecular weight of the polygeline molecules is 35000 with a range of 5000 to 50000. It is available as a 3.5 percent solution in 500 ml plastic bottles (Haemaccel) and in addition to the polygeline there is sodium, potassium, calcium and chloride ions. Polygeline is readily excreted in the urine so has a short half life of about 3-6 hours. This half life increases in patients with impaired renal function to about 16 hours. Polygeline is used in the initial management of hypovolaemia where its dose is limited by the degree of haemodilution which can be tolerated by the patient. In adults this amounts to about 1,500 ml. Histamine release has been reported with polygeline and this may result in hypotension, bronchospasm and skin rash. Recent alterations in its preparation have reduced the incidence of reactions to 0.78 percent.

Hemodilution↗

Myocardial perfusion imaging in humans by contrast echocardiography using polygelin colloid solution.

This study evaluated the myocardial contrast effect and safety of polygelin colloid solution selectively injected into the coronary arteries in 25 patients during two-dimensional echocardiography. Six patients (group I) had selective intracoronary injections of nonagitated and 19 (group II) of hand-agitated polygelin colloid solution. Myocardial contrast was seen on two-dimensional echocardiographic cross sections in three patients of group I and in all patients of group II; in 16 patients it was also seen on M-mode echocardiograms. The contrast effect lasted for 15 to 60 seconds. The intensity of myocardial opacification was not significantly influenced by the amount of polygelin colloid solution injected, heart rate or cardiac size. The total number of contrast-enhanced segments after right and left coronary artery injections delineated the entire cross-sectional area in any given view. None of the patients developed symptoms during or immediately after the injections. One patient had transient second degree atrioventricular block after a right coronary wedge injection, one patient showed a QRS axis shift and two others had transient T wave changes. There were no aortic blood pressure changes and no significant serum enzyme (creatine kinase [CK], CK-MB fraction, glutamic oxaloacetic transaminase) elevation or alterations of left ventricular function assessed echocardiographically. It is concluded that hand-agitated polygelin colloid solution is a useful and safe intracoronary contrast agent for delineating myocardial perfusion areas on two-dimensional echocardiography in humans.

Adolescent↗

Low concentrations of intravenous polygelines promote low-molecular weight proteinuria.

BACKGROUND: Previously we observed that atrial natriuretic peptide (ANP)-induced albuminuria was accompanied by an increase in urinary excretion of the low-molecular weight protein (LMW protein) beta2-microglobulin (beta2-m), suggesting that the albuminuria may at least partly be the result of blockade of tubular protein reabsorption. However, in our experiments ANP was dissolved in the polygeline Haemaccel (Hoechst, Behring-Werke, Marburg Germany) to prevent adhesion of ANP to the infusion system. Anecdotal reports have shown that high dosages of polygelines such as Haemaccel or Gelofusine (Braun NPBI Oss, the Netherlands) may influence tubular protein handling. In the present study we have evaluated the effect of a low and high doses of the polygeline Haemaccel on proteinuria. In addition, we have reassessed the effects of ANP. MATERIALS AND METHODS: We measured urinary beta2-microglobulin (beta2-m) and albumin excretion in healthy volunteers after infusion of a high-dose pure Haemaccel (0.04 mL kg(-1) min(-1) for 60 min), a low-dose Haemaccel (0.01 mL kg(-1) min(-1) for 60 min followed by infusion of 0.02 mL kg(-1) min(-1) for 60 min) and a low-dose Gelofusine (dose comparable to the low-dose Haemaccel). In addition we performed similar studies using ANP dissolved in saline and Haemaccel. RESULTS: Infusion of Haemaccel caused a dose-dependent increase in urinary excretion of beta2-m. There were no differences between Haemaccel and Gelofusine. After infusion of ANP dissolved in Haemaccel urinary beta2-m excretion increased from 0.05 +/- 0.03 microg min(-1) to 27 +/- 10 microg min(-1) and urinary albumin excretion increased from 4.5 +/- 1.1 microg min(-1) to 9.7 +/- 6.3 microg min(-1) (P<0.05). During ANP + saline infusion, urinary beta2-m excretion did not change, whereas the urinary albumin excretion increased from 5.3 +/- 1.5 microg min(-1) to 7.9 +/- 2.4 microg min(-1) (P<0.05). CONCLUSIONS: Our study demonstrates that even low doses of the polygelines Haemaccel and Gelofusine profoundly attenuate the tubular reabsorption of the low-molecular weight protein beta2-m. Atrial natriuretic peptide does not affect tubular protein reabsorption. Therefore, the rise in albuminuria during ANP infusion most likely reflects alterations in glomerular permeability.

Adult↗

Human complement activation by polygeline and dextran 70.

The complement cascade is activated during cardiopulmonary bypass (CPB) and in trauma victims. In order to study whether plasma expanders may contribute to complement activation in these settings, fresh human serum was incubated with dextran 70 and polygeline. C3-activation products and the terminal complement complex (TCC) were quantified in enzyme immunoassays. At 37 degrees C, dextran caused immediate, dose-dependent C3 activation and TCC formation with decline later in the rate of TCC formation relative to serum-saline controls. High doses of polygeline caused slight activation after 15-30 min. The authors tested also the activation under conditions comparable to those found during clinical CPB. Activation induced by dextran and polygeline was increased by dilution of the serum. Furthermore, the plasma expanders counteracted the well-known inhibitory effects of heparin (4 IU/ml) and moderate hypothermia (30 degrees C) on complement activation. The authors conclude that dextran, and to a lesser extent polygeline, may contribute to complement activation during CPB and other clinical settings such as shock treatment.

Cardiopulmonary Bypass↗

The aetiology and pathogenesis of cardiopulmonary bypass-associated metabolic acidosis using polygeline pump prime.

OBJECTIVE: The pathogenesis of the metabolic acidosis of cardiopulmonary bypass (CPB) is not fully understood. New quantitative methods of acid-base balance now make it possible to describe it more clearly. Accordingly, we studied acid-base changes during CPB with polygeline pump prime and defined and quantified the factors which contribute to metabolic acidosis. DESIGN: Prospective cohort study. SETTING: Tertiary institution. PARTICIPANTS: 10 cardiac bypass graft surgery patients. INTERVENTIONS: Sampling of arterial blood at four time intervals: post-induction, on CPB during cooling and rewarming, and at skin closure. Measurement of serum Na+, K+, Mg++, Ca++, Cl-, bicarbonate, and phosphate concentrations, arterial blood gases, and serum albumin, lactate, and pyruvate concentrations at each collection point. Analysis of findings according to quantitative physicochemical principles, including calculation of the strong ion difference apparent, the strong ion difference effective, and the strong ion gap (SIG). MEASUREMENTS AND MAIN RESULTS: All patients developed a mild metabolic acidosis. The median serum standard bicarbonate concentration decreased from 25.0 mEq/l post-induction to 22.3 mEq/l at cooling and 22.2 mEq/l at rewarming (p < 0.05). The standard base excess decreased from a median of 1.55 mEq/l prior to CPB, to -2.50 mEq/l at cooling, -1.65 mEq/l at rewarming and, -0.85 mEq/l at skin closure (p < 0.001). This mild metabolic acidosis occurred despite a decrease in the median serum lactate concentration from 3.20 mEq/l post-induction to 1.83, 1.80, and 1.58 mEq/l at the three other time points. The increase in the median serum chloride concentration from 104.9 mEq/l post induction to 111.0, 111.1, and 110.0 mEq/l at the subsequent time points (p < 0.0001) was the main cause of the acidosis. There was also a significant increase in the SIG of 3.8 mEq/l at cooling and rewarming (p < 0.0001), suggesting a role for other unmeasured anions (polygeline) in the genesis of this acidosis. CONCLUSIONS: Using quantitative biophysical methods, it can be demonstrated that, in patients receiving a pump prime rich in chloride and polygeline, the metabolic acidosis of CPB is mostly due to iatrogenic increases in serum chloride concentration and unmeasured strong anions (SIG). Its development is partially attenuated by iatrogenic hypoalbuminaemia. Changes in lactate concentrations did not play a role in the development of metabolic acidosis in our patients.

Acid-Base Equilibrium↗

Determination of the clearance factor for transmissible spongiform encephalopathy agents during the manufacturing process of polygeline.

OBJECTIVE: To determine the safety of polygeline, a gelatine-derived plasma substitute produced from bovine bones, in terms of safety for bovine spongiform encephalopathy (BSE) by evaluating the ability of the manufacturing process of polygeline to eliminate agents related to transmissible spongiform encephalopathy (TSE) through the validation of three main production steps. DESIGN: Laboratory scale experimental process (in duplicate) using 20% hamster-adapted 263K scrapie-infected brain homogenate as infective titrated source (10(9) LD50/2 ml), added to each material before being processed and titrated in hamsters. Experiment 1: time/temperature dependency of gelatine autoclaving. Experiment 2: cross-linking and distillation. Experiment 3: final sterilization. Monitoring period: 1 year with daily animal clinical observation. Histology of all brains. SETTING: LCG-RBM laboratories, Italy; strict GLP compliance. MEASUREMENTS AND RESULTS: Heating the gelatine (at conditions lower than those used in production process) was very effective in inactivating the infectivity of TSE agents. Clearance factors were reproducible, dependent upon time and temperature, reaching a total theoretical process clearance in the range of 9.2-13.8 [6.9 + 2.3 (+ 4.6)] log10 LD50. CONCLUSIONS: These experimental results provide further important data confirming the safety of the procedural steps; this complements the safety due to the careful sourcing of the raw material. There is high assurance that there is no significant risk of TSE transmission to humans by the therapeutic administration of polygeline.

Animals↗

Randomized trial comparing albumin, dextran 70, and polygeline in cirrhotic patients with ascites treated by paracentesis.

BACKGROUND & AIMS: Paracentesis associated with plasma expanders is widely used for the treatment of ascites in cirrhosis. This study investigated the clinical importance of paracentesis-induced-circulatory dysfunction and compared the efficacy of albumin, dextran 70, and polygeline in preventing this complication. METHODS: A total of 289 cirrhotic patients with ascites were randomized to treatment by total paracentesis plus intravenous albumin (97 patients), dextran 70 (93 patients), or polygeline (99 patients). Postparacentesis circulatory dysfunction was defined as an increase in plasma renin activity on the sixth day after paracentesis of more than 50% of the pretreatment value to a level > 4 ng.mL-1.h-1. RESULTS: Postparacentesis circulatory dysfunction occurred more frequently in patients treated with dextran 70 (34.4%; P = 0.018) or polygeline (37.8%; P = 0.004) than in those receiving albumin (18.5%). The plasma expander used and the volume of ascites removed were independent predictors of this complication. Postparacentesis circulatory dysfunction persisted during follow-up and was associated with a shorter time to first readmission (1.3 +/- 0.5 vs. 3.5 +/- 0.8 months, median +/- SEM; P = 0.03) and shorter survival (9.3 +/- 4.2 vs. 16.9 +/- 4.3 months; P = 0.01). Creatinine and sodium levels in serum, and Child-Pugh score at inclusion, and postparacentesis circulatory dysfunction were independent predictors of survival. CONCLUSIONS: Postparacentesis circulatory dysfunction is not spontaneously reversible and is associated with a shorter time to first readmission and shorter survival. Albumin is the best plasma expander to prevent this complication.

Adult↗

Filling hemodialysis catheters in the interdialytic period: heparin versus citrate versus polygeline: a prospective randomized study.

Heparin and saline are commonly used to fill hemodialysis central venous catheters to prevent their thrombosis during the interdialytic period. The purpose of this prospective clinical study was to evaluate whether replacing heparin with citrate or polygeline could ensure satisfactory catheter function without exposing patients to the risk of systemic heparinization. Thirty end-stage renal disease (ESRD) patients with subclavian or jugular single lumen catheters as temporary vascular access for hemodialysis were enrolled. After the insertion of the catheters, the patients were randomly assigned to one of the following three filling groups: Group A, heparin; Group B, citrate; Group C, polygeline. Before each dialysis, the filling solution was aspirated and clot volume, if present, was measured. The catheter usage time and the clot volume were 23 +/- 24 days and 0.052 +/- 0.035 ml in Group A, 51 +/- 36 days and 0.059 +/- 0.032 ml in Group B, and 32 +/- 10 days and 0.056 +/- 0.038 ml in Group C, respectively. Our results indicate that citrate or polygeline can replace heparin effectively as a filling solution for single lumen temporary hemodialysis catheters.

Aged↗

Fluid balance and pulmonary functions during and after coronary artery bypass surgery: Ringer's acetate compared with dextran, polygeline, or albumin.

The effects on fluid balance, pulmonary functions and economics were evaluated in a randomized comparison of one colloid free and three colloid containing fluid regimens, for 48 hours during and after coronary artery bypass (CAB) surgery. A standard regimen for anaesthesia, extracorporeal circulation and monitoring was used. Only Ringer's acetate (RAc) was used as priming solution for extracorporeal circulation. Forty patients were randomized to receive either RAc, polygeline 35 mg.ml-1 (Haemaccel), dextran 70 (Macrodex) 60 mg.ml-1, or albumin 40 mg.ml-1 in saline whenever fluid volume was needed to stabilize haemodynamics. At the end of the operation, fluid retention was significantly lower in patients receiving polygeline and dextran 70, compared with patients receiving RAc. At 48 hours, however, there were no differences in cumulative fluid balance. Patients in the colloid groups postoperatively had a higher serum colloid osmotic pressure (s-COP), but a higher net lung capillary filtration pressure (delta P) only on the second postoperative day than the RAc group. However, this did not adversely affect intrapulmonary venous admixture, arterial oxygen tension, or time on respirator in the RAc group compared with the colloid groups. The most expensive colloid fluid regimen (albumin) cost about 230 US$ more per patient than the RAc fluid regimen. We conclude that Ringer's acetate for volume replacement to stabilize haemodynamics during and after CAB surgery is associated with increased fluid retention only during the intraoperative period, compared with dextran 70 or polygeline, and with a lower serum colloid osmotic pressure and net lung capillary filtration pressure postoperatively, compared with all three colloid groups. This does not affect pulmonary functions adversely.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗

Early and late histamine release induced by albumin, hetastarch and polygeline: some unexpected findings.

OBJECTIVE: The perioperative use of colloidal plasma substitutes is still under discussion. We therefore conducted a prospective randomised study with three commonly used plasma substitutes to examine their histamine releasing effects in 21 volunteers. MATERIAL OR SUBJETS: 21 male volunteers were enrolled in this prospective, randomised, controlled clinical study. Endpoints were the incidence of early and late histamine release and the time course of the release kinetics. Normovolemic hemodilution technique was used with hydroxyethyl starch (n = 6), human albumin (n = 6) and polygeline (n = 9). Measurement and observation period was 240 min after the start of the plasma substitute infusion. Heart rate, blood pressure, SaO(2), clinical symptoms/signs and plasma histamine were measured during the observation period. RESULTS: The incidence of histamine release over the whole observation period in all three groups was 100%. Histamine release occurred frequently in all three groups until 30 min (50%-78%) and up to 240 min (late release reaction: 67%-83%) after the start of infusion. Surprisingly even hydroxyethyl starch, which is regarded as a generally safe and effective plasma substitute, caused high incidences of late histamine release (67%). Histamine release is a well known side effect of polygeline and - to a lesser extent - also of albumin, but was a novel finding for hydroxyethyl starch. CONCLUSIONS: We demonstrated for the first time histamine releasing effects of hydroxyethyl starch over a long period of time after administration. This perioperatively and for intensive care possibly relevant finding should make clinicians aware of late side effects not yet connected with the clinical use of these colloidal plasma substitutes.

Adult↗

Clinical evaluation of a polygeline-free tick-borne encephalitis vaccine for adolescents and adults.

OBJECTIVE: To evaluate immunogenicity and safety of a polygeline-free tick-born encephalitis (TBE) vaccine in a clinical program. METHOD: A total of 3118 subjects aged 12-76 years were enrolled in three clinical trials. The clinical studies were conducted in 15 centers in three European countries. Evidence of neutralizing TBE antibodies was used as surrogate parameter for efficacy assessment. RESULTS: All subjects analyzed achieved levels of TBE antibodies postimmunization to fulfill the definition of seroconversion or a four-fold increase. The new TBE vaccine appeared to be well tolerated by subjects. Only very few febrile reactions, mainly 38.5 degrees C were reported. No serious or unexpected adverse events related to vaccination were reported. CONCLUSION: These successful results in terms of both immunogenicity and safety indicate that the TBE vaccination with this polygeline-free TBE vaccine can be used safely in adolescents and adults.

Adolescent↗

Prevention of allergoid (cutaneous anaphylactoid) reactions to polygeline (Haemaccel) in orthopaedic patients by premedication with H1- and H2-receptor antagonists.

"Purified" polygeline (Haemaccel) was examined for its anaphylactoid and allergoid reactions in a controlled clinical trial on a homogenous sample of orthopaedic patients. In two test groups histamine H1- and H2-receptor antagonists were applied, in the control group saline as a placebo premedication. Unexpectedly no anaphylactoid reaction associated with histamine release greater than or equal to 1 ng/ml plasma occurred in the trial. Clinically unimportant allergoid reactions restricted to the skin occurred with a lower frequency (18%) than observed in previous trials. The specific premedication was highly effective in preventing these reactions in the two test groups (p less than 0.0005). Due to the apparent improvement of the product a general premedication with histamine H1- and H2-receptor antagonist seems not to be necessary before polygeline is administered to patients. For reasons of safety, however, it seems to be indicated in patients at risk, such as those with carcinoma, a proven allergic diathesis and in those who have already suffered from an incident to plasma substitutes.

Anaphylaxis↗

Colloid solutions in the critically ill. A randomised comparison of albumin and polygeline. 1. Outcome and duration of stay in the intensive care unit.

All patients admitted to an Intensive Care Unit were randomised to receive all volume replacement fluid as either human albumin solution or a synthetic colloid. A total of 475 patients were admitted during the study period. Patients' age, sex, APACHE score and calculated risk of death were assessed on admission. Outcome was assessed as length of Intensive Care stay and mortality. There was no difference between the groups. Subgroups of patients with APACHE score greater than 10, calculated risk of death greater than 50% and length of stay greater than 5 days were also evaluated but not significant differences were found between treatment groups. The use of albumin rather than 3.5% polygeline for volume replacement in the Intensive Care Unit has no influence on outcome.

Adolescent↗

Colloid solutions in the critically ill. A randomised comparison of albumin and polygeline 2. Serum albumin concentration and incidences of pulmonary oedema and acute renal failure.

All patients admitted to an Intensive Care Unit were assigned randomly to one of two groups, A and B. Group A received colloid volume replacement as 4.5% albumin whilst group B received a synthetic colloid, polygeline. This study describes the changes in serum albumin concentration in survivors and nonsurvivors in the two groups during their stay in the Intensive Care Unit. The incidences of renal failure and pulmonary oedema were also assessed. Serum albumin concentration decreased in all nonsurvivors. In survivors the serum albumin concentration decreased to a greater extent in the synthetic colloid group than in the albumin group. Despite the differences in serum albumin concentration there were no significant differences between the groups in the incidences of pulmonary oedema or renal failure.

Acute Kidney Injury↗

A comparison of albumin, polygeline and crystalloid priming solutions for cardiopulmonary bypass in patients having coronary artery bypass graft surgery.

This study was designed to assess the effect of different prime solution compositions on a patient's fluid balance, transfusion requirements, renal function and haemodynamic stability over the first 24 hours postbypass. Ninety-three patients presenting for first-time coronary artery bypass graft (CABG) surgery were randomly allocated to receive one of three prime solutions for the CPB pump: albumin (4.6%) + Plasmalyte (Group A, n = 32), polygeline (Hemaccel) + Plasmalyte (Group P, n = 29), or crystalloid (Plasmalyte) alone (Group C, n = 32). Patients, anaesthetists, surgeons and intensive care unit (ICU) staff were all blinded as to the solution type. The groups were demographically and haemodynamically similar. There were no differences between the groups with respect to white cell or platelet counts during the study. There was a significant difference in haemoglobin levels between the groups on weaning from CPB and on arrival in the ICU (Group C > Groups P and A, p < 0.001 for both times). There was no difference in blood transfusion requirements between any of the groups. During CPB, Group C required significantly more crystalloid than the other groups (p < 0.001). Urine output was significantly higher in Group C compared with Groups P and A at all time periods up to and including ICU 12 hours (p < 0.05). The use of frusemide was significantly higher in the ICU in Groups P and A (p < 0.01). There was a net gain of 3132 +/- 412 ml in Group C in 24 hour fluid balance, which was significantly higher than Group A (2166 +/- 223 ml, p = 0.04). Our results show that, in this patient population, there is no advantage in using a colloid-based prime solution over a purely crystalloid solution from a haemotologic or haemodynamic point of view for the first 24 hours after CPB. There appears to be an increase in extracellular fluid (ECF) retention in Group C, but this caused no related problems in the study period. On the other hand, diuretics (frusemide) needed to be given significantly less often in these patients to offset oliguria.

Albumins↗