Effect of 4% Albumin Solution vs Ringer Acetate on Major Adverse Events in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
| Autor: | Eero Pesonen, Hanna Vlasov, Raili Suojaranta, Seppo Hiippala, Alexey Schramko, Erika Wilkman, Tiina Eränen, Kaapo Arvonen, Maxim Mazanikov, Ulla-Stina Salminen, Mihkel Meinberg, Tommi Vähäsilta, Liisa Petäjä, Peter Raivio, Tatu Juvonen, Ville Pettilä |
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| Přispěvatelé: | University of Helsinki, Clinicum, HUS Perioperative, Intensive Care and Pain Medicine, Anestesiologian yksikkö, Department of Diagnostics and Therapeutics, HUS Pharmacy, HUS Helsinki and Uusimaa Hospital District, HUS Heart and Lung Center, Sydän ja rintaelinkirurgia, III kirurgian klinikka |
| Rok vydání: | 2022 |
| Předmět: |
Male
Cardiopulmonary Bypass Heart Diseases ACUTE KIDNEY INJURY General Medicine Middle Aged 3126 Surgery anesthesiology intensive care radiology Solutions Double-Blind Method Albumins 3121 General medicine internal medicine and other clinical medicine Fluid Therapy Humans Female Cardiac Surgical Procedures Coronary Artery Bypass Isotonic Solutions Aged |
| Zdroj: | JAMA. 328:251 |
| ISSN: | 0098-7484 |
| DOI: | 10.1001/jama.2022.10461 |
| Popis: | IMPORTANCE 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 PARTICIPANTS A 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). INTERVENTIONS The 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 MEASURES The primary outcomewas 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. |
| Databáze: | OpenAIRE |
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