Table 3 Randomized clinical trials of hyperoncotic albumin in other indications
Trial | n | Indication | Regimen | Results |
|---|---|---|---|---|
Liver disease | Â | Â | Â | Â |
Gentilini et al., 1999 [51] | 126 | Cirrhosis and refractory ascites | Inpatient treatment with 12.5 g/day 25% albumin plus diuretics vs diuretics alone | 90.5% cumulative treatment response rate in group receiving albumin vs 74.7% in control group (p < 0.05); shorter hospital stay (p < 0.05) in group receiving albumin (20 vs 24 days) resulting in 59% cost savings; no survival difference |
Sort et al., 1999 [53] | 126 | Cirrhosis with ascites and spontaneous bacterial peritonitis | 1.5 g/kg 20% albumin within 6 h of diagnosis and 1 g/kg on day 3 vs no albumin; intravenous cefotaxime in both groups | Renal impairment in 33% of control group vs 10% of albumin recipients (p = 0.002); 29% hospital mortality in control group vs 10% of group receiving albumin (p = 0.01); 41% and 22% mortality, respectively, by 3 months of follow-up (p = 0.03) |
Fernández et al., 2005 [58] | 20 | Cirrhosis and spontaneous bacterial peritonitis | 20% albumin vs 6% HES 200/0.5, both administered at 1.5 g/kg after baseline measurements and 1.0 g/kg on day 3 | Albumin increased mean arterial pressure and decreased plasma renin activity; no improvements in circulatory function in patients receiving HES; 4 of 10 HES recipients developed spontaneous bacterial peritonitis-induced circulatory dysfunction or renal failure, whereas neither complication occurred in any of the 10 patients receiving albumin |
High-risk neonates | Â | Â | Â | Â |
McMurray et al., 1948 [35] | 33 | Premature infants with low birth weight | 3 ml 25 g/dl albumin injected per pound body weight 1–2 times weekly vs no albumin | 8.5 days shorter mean time to regain birth weight in infants receiving albumin (p = 0.02) and significantly fewer illnesses |
Greenough et al., 1993 [42] | 30 | Ventilator-dependent ill pre-term infants | 5 ml/kg 20% albumin vs placebo | Albumin reduced edema based on weight loss (p < 0.01), whereas control group gained weight (p < 0.05); 27% reduction in inspired oxygen requirement after albumin treatment (p < 0.05) with no change in control group |
Gürkan et al., 2001 [56] | 18 | Newborns with asphyxia and brain edema | 0.5 g/kg 20% albumin vs routine fluid | Higher modified Apgar score in group receiving albumin after 24 h (p < 0.001) with difference persisting 8 days; cerebral edema reduced in greater proportion of albumin than control group as judged by head ultrasound; 28% shorter hospital stay in albumin-treated group (p < 0.01) |
Brain injury | Â | Â | Â | Â |
Goslinga et al., 1992 [40] | 300 | Acute ischemic stroke | Normovolemic hemodilution with 20% albumin vs crystalloids | In subgroup with normal hematocrit accounting for two-thirds of study population, mortality and disability at 3 months significantly lower among albumin recipients |
Tomita et al., 1994 [43] | 18 | Closed head injury | High-oncotic-pressure therapy with 25% albumin and furosemide vs normal-oncotic-pressure therapy | Recovery with minimal or no neurological deficit in patients of high-oncotic-pressure therapy group; persistent vegetative state or death in 30% of patients receiving normal-oncotic-pressure therapy |
Intradialytic hypotension | Â | Â | Â | Â |
van der Sande et al., 1999 [54] | 10 | Crossover trial of stable dialysis patients | 20% albumin vs 10% HES 200/0.5 vs saline, in conjunction with ultrafiltration and hemodialysis | Greater decrease in blood volume with saline than other fluids (p < 0.05) |
van der Sande et al., 2000 [55] | 9 | Crossover trial of cardiac-compromised dialysis patients | 100 ml of 20% albumin vs 10% HES 200/0.5 vs 3% hypertonic saline, in conjunction with ultrafiltration and hemodialysis | Greater intradialytic reductions in systolic blood pressure (p < 0.05) and blood volume (p < 0.05) with hypertonic saline than either albumin or HES |
Nephrotic syndrome | Â | Â | Â | Â |
Kosnadi et al., 1987 [38] | 24 | Children with nephrotic syndrome | 20% albumin + furosemide + prednisone vs human plasma + furosemide + prednisone vs prednisone alone | Diuresis earlier with albumin + furosemide + prednisone vs prednisone alone (p = 0.011) and percent body weight loss greater (p < 0.01) |
Fliser et al., 1999 [50] | 9 | Double-blind, placebo-controlled crossover trial in patients with nephrotic syndrome on standardized salt intake | 200 ml 20% albumin + 0.9% NaCl sham infusion vs 200 ml 20% albumin + 60 mg furosemide vs 60 mg furosemide + sham infusion of 200 ml H2O | Urinary volume and sodium excretion higher by 20% (p < 0.05 and p < 0.01, respectively) during first 8 h with albumin + furosemide than furosemide alone |
Na et al., 2001 [57] | 7 | Crossover trial in patients with nephrotic syndrome | 100 ml 20% albumin vs 5% dextrose followed by 160 mg of furosemide | Albumin potentiated the diuretic effect of furosemide |