Randomized trial of volume expansion with albumin or saline in children with severe malaria: preliminary evidence of albumin benefit. Albumin supplementation in the critically ill. A prospective, randomized trial. Albumin administration improves organ function in critically ill hypoalbuminemic patients: A prospective, randomized, controlled, pilot study. Volume expansion with albumin compared to gelofusine in children with severe malaria: results of a controlled trial. [Effect of hydroxyethyl starch HES 450/0.7 and 5% human albumin on the colloid osmotic pressure and hemodynamic parameters in hypovolemic patients after major abdominal procedures]. Therapeutic influence of 20 % albumin versus 6% hydroxyethylstarch on extravascular lung water in septic patients: a randomized controlled trial. Maintenance of serum albumin levels in pediatric burn patients: a prospective, randomized trial. A prospective analysis of hypertonic lactated saline v. Ringer's lactate-colloid for the resuscitation of severely burned children. Efficacy of albumin supplementation in the surgical intensive care unit: a prospective, randomized study.
Metabolic acidosis is the best predictor of death in children with severe falciparum malaria; however, its treatment presents a therapeutic dilemma, because acidosis and hypovolemia may coexist with coma, which can be associated with elevated intracranial pressure. We postulated that volume resuscitation with albumin might correct acidosis and hypovolemia with a lower risk of precipitating cerebral edema than crystalloid. In an open-label, randomized, controlled trial, we compared the safety of resuscitation with albumin to saline in Kenyan children with severe malaria.
                We randomly assigned children with severe malaria and metabolic acidosis (base deficit, >8 mmol/L) to receive fluid resuscitation with either 4.5% albumin or normal saline. A control (maintenance only) group was only included for patients with a base deficit of <15 mmol/L. The primary outcome measure was the percentage reduction in base deficit at 8 h. Secondary end points included death, the requirement for rescue therapies, and neurological sequelae in survivors.
                Of 150 children recruited for the trial, 61 received saline, 56 received albumin, and 33 served as control subjects. There was no significant difference in the resolution of acidosis between the groups; however, the mortality rate was significantly lower among patients who received albumin (3.6% [2 of 56 patients]) than among those who received saline (18% [11 of 61]; relative risk, 5.5; 95% confidence interval, 1.2-24.8; P=.013).
                In high-risk children with severe malaria and acidosis, fluid resuscitation with albumin may reduce mortality. Our study design did not enable us to determine whether saline administration is preferable to fluid restriction or whether saline administration is actually hazardous. Further studies are needed to confirm our findings before definitive treatment recommendations can be made. Albumin replacement to correct hypoalbuminemia in critically ill patients has been controversial. This study was a prospective, randomized trial of 25% albumin administration in 40 hypoalbuminemic (serum albumin, less than 25 g/L [2.5 g/dL]), critically ill patients. The treatment group (18 patients) received 25% albumin supplementation to achieve and maintain serum albumin levels of 25 g/L (2.5 g/dL) or greater, while the nontreatment group (22 patients) received no concentrated albumin. There was no clinical benefit from albumin therapy when assessing mortality (39% vs 27%, treatment vs control) or major complication rate (89% vs 77% of patients). There were also no significant differences in length of hospital stay, intensive care unit stay, ventilator dependence, or tolerance of enteral feeding, despite significant elevations of albumin in the treatment group. The costly use of exogenous albumin as treatment for hypoalbuminemia in this patient population does not appear to be justified. To test the hypothesis that administration of albumin to correct hypoalbuminemia might have beneficial effects on organ function in a mixed population of critically ill patients.
                : Prospective, controlled, randomized study.
                Thirty-one-bed, mixed medicosurgical department of intensive care.
                All adult patients with a serum albumin concentration < or =30 g/L were assessed for eligibility. Principal exclusion criteria were expected length of stay <72 hrs, life expectancy <3 months or a do-not-resuscitate order, albumin administration in the preceding 24 hrs, or evidence of fluid overload.
                The 100 patients were randomized to receive 300 mL of 20% albumin solution on the first day, then 200 mL/day provided their serum albumin concentration was <31 g/dL (albumin group), or to receive no albumin (control group).
                The primary outcome was the effect of albumin administration on organ function as assessed by a delta Sequential Organ Failure Assessment score from day 1 to day 7 (or the day of intensive care discharge or death, whichever came first). The two groups of 50 patients were comparable at baseline for age, gender, albumin concentration, and Acute Physiology and Chronic Health Evaluation II score. Albumin concentration did not change over time in the control group but increased consistently in the albumin group (p < .001). Organ function improved more in the albumin than in the control group (p = .026), mainly due to a difference in respiratory, cardiovascular, and central nervous system components of the Sequential Organ Failure Assessment score. Diuretic use was identical in both groups, but mean fluid gain was almost three times higher in the control group (1679 +/- 1156 vs. 658 +/- 1101 mL, p = .04). Median daily calorie intake was higher in the albumin than in the control group (1122 [935-1158] vs. 760 [571-1077] kcal, p = .05).
                Albumin administration may improve organ function in hypoalbuminemic critically ill patients. It results in a less positive fluid balance and a better tolerance to enteral feeding. Previous studies have shown that in children with severe malaria, resuscitation with albumin infusion results in a lower mortality than resuscitation with saline infusion. Whether the apparent benefit of albumin is due solely to its colloidal properties, and thus might also be achieved with other synthetic colloids, or due to the many other unique physiological properties of albumin is unknown. As albumin is costly and not readily available in Africa, examination of more affordable colloids is warranted. In order to inform the design of definitive phase III trials we compared volume expansion with Gelofusine (succinylated modified fluid gelatin 4% intravenous infusion) with albumin.
                This study was a phase II safety and efficacy study.
                The study was conducted at Kilifi District Hospital, Kenya.
                The participants were children admitted with severe falciparum malaria (impaired consciousness or deep breathing), metabolic acidosis (base deficit > 8 mmol/l), and clinical features of shock.
                The interventions were volume resuscitation with either 4.5% human albumin solution or Gelofusine.
                Primary endpoints were the resolution of shock and acidosis; secondary endpoints were in-hospital mortality and adverse events including neurological sequelae.
                A total of 88 children were enrolled: 44 received Gelofusine and 44 received albumin. There was no significant difference in the resolution of shock or acidosis between the groups. Whilst no participant developed pulmonary oedema or fluid overload, fatal neurological events were more common in the group receiving gelatin-based intervention fluids. Mortality was lower in patients receiving albumin (1/44; 2.3%) than in those treated with Gelofusine (7/44; 16%) by intention to treat (Fisher's exact test, p = 0.06), or 1/40 (2.5%) and 4/40 (10%), respectively, for those treated per protocol (p = 0.36). Meta-analysis of published trials to provide a summary estimate of the effect of albumin on mortality showed a pooled relative risk of death with albumin administration of 0.19 (95% confidence interval 0.06-0.59; p = 0.004 compared to other fluid boluses).
                In children with severe malaria, we have shown a consistent survival benefit of receiving albumin infusion compared to other resuscitation fluids, despite comparable effects on the resolution of acidosis and shock. The lack of similar mortality benefit from Gelofusine suggests that the mechanism may involve a specific neuroprotective effect of albumin, rather than solely the effect of the administered colloid. Further exploration of the benefits of albumin is warranted in larger clinical trials. In a randomized study 20 patients with hypovolemia following abdominal surgery for malignoma were treated with 500 ml HES 450/0.7 or human albumin 5% during the first 24 h after operation. COP and various blood- and hemodynamic parameters were measured immediately before and after infusion as well as 2, 4 and 6 h after infusion. After HES-infusion COP increased from 20.2 to about 22 mmHg and remained at a significantly higher level (p less than 0.01) for 6 h. After albumin-infusion COP increased from 19.7 to 20.7 mmHg, but already returned to starting level within 2 h. CVP in the HES-group increased from 2.8 to 6.3 cmH2O after infusion, and then gradually dropped to 4 cmH2O during 6 h. In the albumin-group CVP increased from the same starting level only to 4.2 cmH2O, and then dropped back to 3.2 cmH2O after 6 h (no significant difference to the starting level). The other blood- and hemodynamic parameters measured showed no significant differences between the two groups. The results show that a quick and reliable improvement of hypovolemia can be obtained in both groups immediately after infusion, but that the COP- and volume-stabilizing effects of HES-infusion are more distinct and remained for a significantly longer period of time than the effects of albumin 5%-infusion. Recent studies demonstrated that extravascular lung water (EVLW) is a reliable and independent marker for outcome. The primary therapeutically goal in critically ill patients is to resuscitate and retain adequate organ perfusion by fluid administration, where is necessary to achieve adequate intravascular filling, but avoid initiation of pulmonary edema.
                Patients with severe sepsis were randomly allocated to a group treated with 20% Albumin 100 ml every 12 hours (ALB; n = 30) or with 6% hydroxyethylstarch 130/0, 4 250 ml every 6 hours (HES; n = 26). Both treatments were completed by crystalloids or norephinephrin as necessary. We analyzed amount of developed EVLW, and relation with mortality, PaO2/FiO2 and alveolo-arterial oxygen difference.
                We observed significantly greater decrease of EVLW when compared with baseline during whole monitored period of 72 hours in ALB group in contrast to HES patients (p < 0.05). Despite no significant changes of EVLW in HES group, we noted improve of PaO2/FiO2 and AaDO2 in both groups. We did not observed significant difference in mortality.
                The present study results show can summarize that albumin reduces in a higher amount and earlier the extravascular lung water than HES, but this reduction was not associated with improvement of oxygenation functions, which was better in HES group. A prospective, randomized trial was performed to determine whether maintaining serum albumin levels in burned pediatric patients had any effect on morbidity and mortality. Patients < 19 years of age with burns > 20% total body surface area were randomized to receive supplemental albumin to maintain levels 2.5 to 3.5 g/dL ("High Albumin") or were given albumin only if levels dropped < 1.5 g/dL ("Low Albumin") after completing burn shock resuscitation. The 36 patients in the Low Albumin group were well matched for age, burn size, depth of injury, and inhalation injury when compared with the High Albumin group (34 patients). As expected, serum albumin levels were significantly lower in the Low Albumin group when compared with the High Albumin group. No differences between groups were noted for resuscitation needs, maintenance fluid requirements, urine output, tube feedings received, days of antibiotic treatment, or ventilatory requirements. No differences in hematology, electrolytes, or nutritional laboratories were found. Finally, length of stay, complication rate, and mortality were not affected by albumin treatment. Albumin supplementation to maintain normal serum levels does not seem to be warranted in previously healthy children who suffer severe burns and who receive adequate nutrition. Children and young people ranging in age from 5 months to 21 years, with burns covering greater than or equal to 30 per cent of the body surface area, were entered into a prospective study comparing the resuscitative efficacy of hypertonic lactated saline (HLS) and Ringer's lactate-colloid (RL-colloid). The 24- and 48-h fluid requirements of children resuscitated with the RL-colloid were significantly greater than those resuscitated with HLS (P less than 0.02); 2.37 +/- 0.91 ml/kg/per cent burn (HLS) v. 3.43 +/- 1.51 ml/kg/per cent burn (RL-colloid) at 24 h post-burn and 4.18 +/- 1.37 ml/kg/per cent burn (HLS) v. 6.32 +/- ml/kg/per cent burn (RL-colloid) at 48 h (P less than 0.01). The urine output between the two groups was not significantly different, and the haematocrits were equally maintained. Patients in the RL-colloid group gained significantly more weight at 48 h (P less than 0.05). The sodium requirements and resulting sodium balances were not significantly different. The desired and significant elevation (P less than 0.001) of serum sodium in the HLS group was maintained for the 5 days of the study. Colloid oncotic pressures, serum albumin and albumin/globulin (A/G) ratios were not significantly different between the two groups until 48 h post-burn. The RL-colloid group received plasmanate during the second 24-h period. The significant elevation in serum albumin, A/G ratio and colloid oncotic pressure persisted for only 2 days--by 96 h post-burn these values were no longer significantly different.(ABSTRACT TRUNCATED AT 250 WORDS) To determine the efficacy of supplemental 25% albumin in reducing morbidity and mortality rates in the surgical intensive care unit (ICU).
                Prospective, randomized, unblinded clinical study.
                Surgical ICU in a community hospital.
                Two hundred nineteen patients with admission circulating albumin concentrations of < 3.0 g/dL (< 30 g/L). The groups were well matched regarding age, sex, Acute Physiology and Chronic Health Evaluation II scores and initial circulating albumin concentrations.
                The treatment group (n = 116) received 37.5 g/day of albumin until the circulating albumin concentration increased to > 3.0 g/dL (> 30 g/L). The control group (n = 103) received no supplemental albumin. Both groups received standard nutritional support.
                The complication rate was 44% in the albumin group vs. 36.9% in the controls (p = .29). The albumin patients had a mortality rate of 10.3% vs. 5.8% in the control group (p = .22). There were no significant differences between the groups in the number of days spent receiving mechanical ventilation or in the tolerance to tube feedings.
                Routine supplemental administration of 25% albumin is expensive and offers no apparent outcome advantage and should be abandoned in the treatment of patients in the surgical ICU.
For patients with hypovolaemia, there is no evidence that albumin reduces mortality when compared with cheaper alternatives such as saline. There is no evidence that albumin reduces mortality in critically ill patients with burns and hypoalbuminaemia. The possibility that there may be highly selected populations of critically ill patients in which albumin may be indicated remains open to question. However, in view of the absence of evidence of a mortality benefit from albumin and the increased cost of albumin compared to alternatives such as saline, it would seem reasonable that albumin should only be used within the context of well concealed and adequately powered randomised controlled trials.