Human albumin and starch administration in critically ill patients: a prospective randomized clinical trial.

Objective: To determine whether intravenous infusion of either human albumin or hydroxyethyl-starch (HES) in hypo-albuminemic critically ill may lead to an increase in colloid osmotic pressure and to a better clinical outcome, i.e. lower mortality and fewer complications, compared to fluid replacement with normal saline.

Design: Prospective, randomized controlled clinical trial during 72 hours in 61 consecutively admitted severely ill patients. Randomisation took place by sealed envelope, kept outside of the hospital.

Setting: Intensive care unit of the Twenteborg Hospital, Almelo, The Netherlands.

Subjects: Sixty-three severely ill, hypo-albuminemic patients were selected; 27 patients had severe sepsis and 36 were post-surgical patients with SIRS. Two patients died shortly after randomization, 15 patients received human albumin, 15 HES 500 and 15 HES 1000 ml, and 16 saline.

Interventions: The patients were randomized to receive 300 ml human albumin (20%) per day, or 1000 ml normal saline per day, or 500 ml or 1000 ml HES per day, all for 72 hours.

Main Outcome Measures: The primary outcome was plasma colloid osmotic pressure (COP). Secondary endpoints were fluid balance and the development of pulmonary edema.

Results: Administration of human albumin was effective in raising COP (P<0.001 on day 2 and day 3, compared to saline and HES). Neither fluid balances nor the development of peripheral or pulmonary edema were different between the groups. Mortality as well as length of stay at ICU were slightly higher in the group receiving human albumin, although not statistically significant.

Conclusion: Raising colloid osmotic pressure with human albumin in hypoalbuminemic patients is not associated with improvement of the clinical outcome.