Trial does not support albumin as primer, volume replacement solution in CABG
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A 4% albumin solution for priming and perioperative IV volume replacement solution in CABG did not reduce risk for 90-day major adverse events compared with standard Ringer’s acetate solution, researchers reported.
The results of the Albumin in Cardiac Surgery (ALBICS) trial, a randomized, double-blind, parallel-group trial at Helsinki University Hospital, were published in JAMA.
“Among patients undergoing cardiac surgery with cardiopulmonary bypass, treatment with 4% albumin solution for priming and perioperative intravenous volume replacement compared with Ringer acetate did not significantly reduce the risk of major adverse events over the following 90 days,” Eero Pesonen, MD, PhD, of the department of anesthesiology, intensive care and pain medicine at the University of Helsinki and Helsinki University Hospital, and colleagues wrote. “These findings do not support the use of 4% albumin solution in this setting.”
Prior research had shown that use of an albumin solution in CABG priming maintained cardiac function better compared with crystalloids and reduced the decrease in platelet count and excessive fluid balance, according to the study background.
Therefore, researchers conducted the ALBICS trial to compare the 90-day safety and efficacy of 4% albumin with Ringer’s acetate as the priming solution in CABG and intraoperative and postoperative volume replacement in patients who underwent on-pump cardiac surgery.
A total of 1,386 patients completed the trial (mean age, 65 years; 79% men). The primary outcome was the number of patients who experienced at least one major adverse event by 90 days, including death, MI, acute HF, resternotomy, stroke, arrhythmia, bleeding, infection or acute kidney injury.
During CABG priming, IV volume replacement intraoperatively and up to 24 hours postoperatively, a median of 2,150 mL of 4% albumin was administered individually in the intervention group and 3,298 mL of Ringer’s acetate solution was administered in the control group.
Researchers reported that 37.1% of patients in the albumin arm and 33.8% of the Ringer’s acetate group experienced at least one major adverse event, translating to an RR of 1.1 (95% CI, 0.95-1.27; P = .2) and an absolute difference of 3.3 percentage points (95% CI, –1.7 to 8.4).
The most common adverse events were pulmonary embolus (1.6% in the albumin group vs. 1.2% in the Ringer’s group), postpericardiotomy syndrome (1.3% in both groups) and pleural effusion with ICU or hospital readmission (1% in the albumin group vs. 1.3% in the Ringer’s group).
“In the present study, the acute kidney injury incidence ... was only 3%, similar to the previously reported incidence of 3.3% in the study site,” the researchers wrote. “With such a low incidence, a significant difference was not detected in acute kidney injury between the study groups. In addition, the low mortality corroborates a previous finding from the study site. Due to low incidences, conclusions on the effects of albumin on acute kidney injury or mortality, even of an exploratory nature, cannot be drawn.”
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