Effect of 4% Albumin Solution vs Ringer Acetate on Major Adverse Events in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Abstract

In cardiac surgery, albumin solution may maintain hemodynamics better than crystalloids and reduce the decrease in platelet count and excessive fluid balance, but randomized trials are needed to compare the effectiveness of these approaches in reducing surgical complications.OBJECTIVE To assess whether 4% albumin solution compared with Ringer acetate as cardiopulmonary bypass prime and perioperative intravenous volume replacement solution reduces the incidence of major perioperative and postoperative complications in patients undergoing cardiac surgery. DESIGN, SETTING, AND PARTICIPANTSA randomized, double-blind, single-center clinical trial in a tertiary university hospital during 2017-2020 with 90-day follow-up postoperatively involving patients undergoing on-pump coronary artery bypass grafting; aortic, mitral, or tricuspid valve surgery; ascending aorta surgery without hypothermic circulatory arrest; and/or the maze procedure were randomly assigned to 2 study groups (last follow-up was April 13, 2020). INTERVENTIONSThe patients received in a 1:1 ratio either 4% albumin solution (n = 693) or Ringer acetate solution (n = 693) as cardiopulmonary bypass priming and intravenous volume replacement intraoperatively and up to 24 hours postoperatively. MAIN OUTCOMES AND MEASURESThe primary outcome was the number of patients with at least 1 major adverse event: death, myocardial injury, acute heart failure, resternotomy, stroke, arrhythmia, bleeding, infection, or acute kidney injury. RESULTS Among 1407 patients randomized, 1386 (99%; mean age, 65.4 [SD, 9.9] years; 1091 men [79%]; 295 women [21%]) completed the trial. Patients received a median of 2150 mL (IQR, 1598-2700 mL) of study fluid in the albumin group and 3298 mL (IQR, 2669-3500 mL) in the Ringer group. The number of patients with at least 1 major adverse event was 257 of 693 patients (37.1%) in the albumin group and 234 of 693 patients (33.8%) in the Ringer group (relative risk albumin/Ringer, 1.10; 95% CI, 0.95-1.27; P = .20), an absolute difference of 3.3 percentage points (95% CI, −1.7 to 8.4). The most common serious adverse events were pulmonary embolus (11 [1.6%] in the albumin group vs 8 [1.2%] in the Ringer group), postpericardiotomy syndrome (9 [1.3%] in both groups), and pleural effusion with intensive care unit or hospital readmission (7 [1.0%] in the albumin group vs 9 [1.3%] in the Ringer group).CONCLUSIONS AND RELEVANCE Among patients undergoing cardiac surgery with cardiopulmonary bypass, treatment with 4% albumin solution for priming and perioperative intravenous volume replacement solution compared with Ringer acetate did not significantly reduce the risk of major adverse events over the following 90 days. These findings do not support the use of 4% albumin solution in this setting.

Priming of Cardiopulmonary Bypass with Human Albumin Decreases Endothelial Dysfunction after Pulmonary Ischemia–Reperfusion in an Animal Model

“…Even if no difference was found concerning the incidence of clinically important adverse cardiac events, albumin significantly reduced the postoperative plasma creatine kinase-MB. This finding could be explained by the protective role of albumin on the coronary glycocalyx [ 19 ]. Even if, to our knowledge, no study using HA has been used on mechanical circulatory support during lung transplantation, it is important to highlight that human albumin is one of the main components of Steen’s solution used in the ex vivo lung perfusion with the Toronto protocol [ 20 ].…”

A retrospective comparison of albumin versus mannitol priming fluid with relation to postoperative atrial fibrillation

“…for a permanent pacemaker) with use of albumin compared to ringer acetate after cardiac surgery. 24 While perinexal conduction was altered with in-vitro studies of albumin versus mannitol solutions, human metabolism, and interstitial fluid exhibit much greater regulation. Infused albumin typically has a half-life of around 110 min in healthy subjects.…”

“…Retrospective studies have since shown improved mortality and less positive fluid balance with albumin use compared to crystalloids in cardiac surgery 22,23 . A single‐center prospective clinical trial (NCT02560519) was recently published by Pesonen et al, and found no significant difference in adverse events, including arrhythmias (defined as ventricular arrhythmias, POAF, or need for a permanent pacemaker) with use of albumin compared to ringer acetate after cardiac surgery 24 …”

Diagnosis, pathophysiology and preventive strategies for cardiac surgery-associated acute kidney injury: a narrative review

“…In terms of the choice of crystalloid, perioperative use of chloride liberal intravenous fluid was found to be associated with hyperchloremic metabolic acidosis and increased postoperative AKI in patients who underwent off-pump coronary artery bypass grafting surgery [ 130 ]. When compared with Ringer acetate, 4% albumin solution for priming CPB and perioperative venous volume replacement solution cannot reduce the incidence of CSA-AKI [ 131 ].…”