Almost 7 000 patients participated in the study, the risk of death for patients who received albumin was the same as that of patients who received saline (relative risk 0.99, confidence interval 95 % 0.91 to 1.09), which is answer questions about the safety of albumin raised in 1998. However, the study did not include severe burns, and exploratory analysis of the subgroup of trauma victims revealed that the mortality rate associated with the use of albumin was higher in patients who had a concomitant brain injury (relative risk 1.36, confidence interval 95% 0.99 to 1.86, p = 0.04). There was better survival in patients with sepsis who received albumin, but this observation was not significant statistically (relative risk 0.87, confidence interval 95% 0.74 to 1 , 02, p = 0.09), and its importance clinically is unclear. It should be noted that the study was not powered to show differences between subgroups and that such differences may be due to chance.
A new meta-analysis of various studies, including the SAFE study, conducted by the Cochrane Injuries Group3 and published October 18, 2004, the relative risk of death associated with the use of albumin in Hypovolemic patients would be 1, 01 (confidence interval 95% 0.92 to 1.10), so the use of albumin does not increase nor decrease mortality rate in these patients.
To determine whether the use of albumin has certain advantages or risks in certain subgroups of patients, we must conduct studies that focus specifically on this issue and have the necessary power.
The identification, characterization and management of adverse events related to a marketed health product depend on the active participation of health professionals program for reporting adverse reactions.
Research of Albumin
