Study Design Summary: Multicenter, double-blind trial of 6,997 ICU patients to receive 4% albumin or saline as choice of resuscitation fluid while in the ICU, with primary outcome as all cause mortality at 28 days.
Notes: The study intervention was specifically resuscitation fluid, patients were placed on the physicians’ choice of maintenance fluids. The authors do no list time from admission/presentation to randomization, but patients were included for 28 days or until death. Noteably, once patients left the ICU they were no longer controlled as to which resuscitation fluid was given, but the rates of patients receiving resuscitation fluid outside of the ICU between the control and intervention group was the same.
The groups were similar in their baseline characteristics including age, source of admission to the ICU (ED, OR, hospital ward…), APACHE II scores, organ failure, percentage of patients on the vent, CRRT, and physiological variables such as HR, MAP, CVP, urine output and serum albumin.
Patients in the intervention group received significantly less fluids on the first 3 days after randomization and significantly more pRBC on the first 2 days. The control group had a significantly higher net positive fluid balance on the first 3 days after randomization by roughly 1/2 liter per day. MAP and HR did not different significantly between the groups. There was a significant difference in the serum albumin concentration between the two groups, higher in the intervention group as expected.
There was no difference between the groups in all cause mortality at 28 days, length of ICU stay, length of hospital stay, duration of mechanical ventilation, duration of CRRT, or rate of new organ failure. In predefined subgroups there was a trend towards improvement in mortality in the saline group in trauma patients. This in combination with the significantly more pRBC given to the intervention group was explained by the authors as possibly due to greater hemodilution from the albumin as a known improved volume expander, with possible changes in coagulation in the albumin group. The authors note this is a secondary outcome and would need a more directed study to asses for any true mortality difference.
Study Conclusion: There is no difference in 28 day all cause mortality for patients receiving 4% albumin vs saline fluids.
Fusion Beat Bottom Line Impression: There is no mortality benefit to choosing albumin vs saline as resuscitation fluid.