麻豆传媒

Albumin solution was no better than Ringer acetate at reducing complications from cardiac surgery with cardiopulmonary bypass in a randomized clinical trial.

Likelihood of at least one major adverse event within 90 days after elective surgery -- counting death, myocardial injury, acute heart failure, resternotomy stroke, arrhythmia, bleeding, infection, and acute kidney failure -- did not differ whether 4% albumin or Ringer acetate had been administered as a cardiopulmonary bypass primer and perioperative intravenous volume replacement (RR 1.10, 95% CI 0.95-1.27), according to the ALBICS study published in .

Myocardial injury was significantly less likely in the albumin group (RR 0.44, CI 95% 0.28-0.68). However, incidences of bleeding (RR 1.73, 95% CI 1.12-2.68), resternotomy (RR 1.85, 95% CI 1.28-2.68), and infection (RR 1.45, 95% CI 1.07-1.97) were all significantly more likely for those receiving the colloid, reported Eero Pesonen, MD, PhD, from Helsinki University Hospital in Finland, and colleagues.

Albumin had been thought to maintain hemodynamics better than crystalloids given its antioxidative and anti-inflammatory properties, enzymatic and signaling functions, colloid osmotic effect, and its ability to transport hydrophobic molecules and preserve the endothelial glycocalyx.

Yet Pesonen's group reported that total fluid balance during the intervention period was significantly lower for patients in the albumin group, whereas chest tube drainage and the administration of red blood cells or platelets were significantly higher.

Thus, the findings do not support the use of 4% albumin solution in cardiac surgery with cardiopulmonary bypass, the group said.

Study results "suggest a potential for harm of using albumin in cardiac surgery due to the association of albumin with increased bleeding, resternotomy, transfusion requirements, and infection," Mihai Podgoreanu, MD, and Negmeldeen Mamoun, MD, PhD, both of Duke University in Durham, North Carolina, cautioned in an .

Podgoreanu and Mamoun noted that albumin and balanced crystalloids have been thought to have clinical equipoise in cardiac surgery. There is wide variation in fluid replacement strategies in current practice, they added.

"[T]he results from the ALBICS trial indicate that further debate is not required for one patient subpopulation -- routine use of albumin should be avoided for patients undergoing cardiac surgery with cardiopulmonary bypass," the duo concluded.

ALBICS was a randomized, double-blind, single center clinical trial conducted at the Helsinki University Hospital in Finland. Investigators collected data from 1,407 patients (mean age 65.4 years and 79% men) from 2017 to 2020 with a 90-day follow-up. Participants had to be undergoing on-pump coronary artery bypass grafting, valve surgery, ascending aorta surgery, or the maze procedure in order to be part of the trial.

Those receiving emergency surgery, congenital cardiac surgery, with an infection anticipated to compromise rehabilitation, ongoing heart failure, end-stage kidney disease, hemophilia, and patient refusal of blood products were excluded. Patients were also excluded if they had used ticagrelor (Brilinta), prasugrel (Effient), clopidogrel (Plavix), apixaban (Eliquis), or rivaroxaban (Xarelto) within 2 days of surgery, or dabigatran (Pradaxa) within 3 days of surgery.

Each person undergoing cardiopulmonary bypass received blinded study solution given for replacement volume up to 3,200 mL, with Ringer acetate being given afterwards if needed. Dosing of the assigned fluids was based on clinical judgment.

Pesonen and colleagues acknowledged the difficulty of generalizing the ALBICS data from a single tertiary university hospital. Also limiting the study's generalizability were the many exclusion criteria of surgical patients.

Additionally, most ALBICS participants received one or the other assigned treatment alone for volume replacement for up to 24 hours after surgery. "Thus, extrapolation of the study results to typical parallel clinical use of both crystalloids and colloids throughout the clinical course, especially if large volumes are needed, should be done with caution," according to the authors.

"There is no doubt the ALBICS trial will not settle the albumin-crystalloid debate. This study raises additional important research questions for potential indications of albumin utilization in cardiothoracic resuscitation," Podgoreanu and Mamoun wrote.

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