芬兰赫尔辛基大学医院Ville Pettilä团队比较了4%白蛋白溶液与醋酸林格溶液对体外循环心脏手术患者重大不良事件的影响。相关论文于2022年7月19日发表在《美国医学会杂志》上。

在心脏手术中，白蛋白溶液可能比晶体溶液更好地维持血流动力学，并减少血小板计数下降和过度体液平衡，但需要进行随机试验来比较这些方法在减少手术并发症方面的有效性。

为了评估4%白蛋白溶液与作为体外循环初期和围手术期静脉容量置换溶液的醋酸林格溶液相比，是否可以降低心脏手术患者围手术期和术后主要并发症的发生率，研究组在一所三级大学医院进行了一项随机、双盲、单中心临床试验，2017-2020年，对接受体外循环冠状动脉旁路移植术，主动脉瓣、二尖瓣或三尖瓣手术，无低温停循环的升主动脉手术，和/或心房迷宫术的患者进行90天术后随访；这些患者被随机分配到2个组（最后一次随访时间为2020年4月13日）。

将患者以1：1的比例分组，分别接受4%白蛋白溶液（693例）或醋酸林格溶液（693例）作为术中和术后24小时的体外循环预充和静脉容量置换。主要结局为至少出现1种重大不良事件的患者数量：死亡、心肌损伤、急性心力衰竭、再狭窄、中风、心律失常、出血、感染或急性肾损伤。

在随机分配的1407名患者中，1386名（99%；平均年龄65.4岁；1091名为男性[79%]；295名为女性[21%]）完成了试验。白蛋白组患者接受的研究液中位数为2150毫升，醋酸林格组为3298毫升。白蛋白组693例患者中有257例（37.1%）出现至少1种重大不良事件，醋酸林格组693例患者中有234例（33.8%），相对风险为1.10，组间差异不显著。最常见的严重不良事件是肺栓塞（白蛋白组为11例[1.6%]，醋酸林格组为8例[1.2%]）、心包切开后综合征（两组均为9例[1.3%]）和重症监护病房或再入院时胸腔积液（白蛋白组为7例[1.0%]，醋酸林格组为9例[1.3%]）。

研究结果表明，对于接受体外循环心脏手术的患者，与醋酸林格液相比，使用4%白蛋白溶液进行预充和围手术期静脉容量置换治疗并不能显著降低随后90天内发生重大不良事件的风险。

附：英文原文

Title: Effect of 4% Albumin Solution vs Ringer Acetate on Major Adverse Events in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Randomized Clinical Trial

Author: Eero Pesonen, Hanna Vlasov, Raili Suojaranta, Seppo Hiippala, Alexey Schramko, Erika Wilkman, Tiina Ernen, Kaapo Arvonen, Maxim Mazanikov, Ulla-Stina Salminen, Mihkel Meinberg, Tommi Vhsilta, Liisa Petj, Peter Raivio, Tatu Juvonen, Ville Pettil

Issue&Volume: 2022/07/19

Abstract:

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 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.

DOI: 10.1001/jama.2022.10461

Source: https://jamanetwork.com/journals/jama/article-abstract/2794363