心脏手术中多巴酚丁胺减量与全剂量使用策略的比较：一项随机非劣效性试验

Dobutamine-sparing versus dobutamine-to-all strategy in cardiac surgery: a randomized noninferiority trial.

作者信息

Franco Rafael Alves, de Almeida Juliano Pinheiro, Landoni Giovanni, Scheeren Thomas W L, Galas Filomena Regina Barbosa Gomes, Fukushima Julia Tizue, Zefferino Suely, Nardelli Pasquale, de Albuquerque Piccioni Marilde, Arita Elisandra Cristina Trevisan Calvo, Park Clarice Hyesuk Lee, Cunha Ligia Cristina Camara, de Oliveira Gisele Queiroz, Costa Isabela Bispo Santos da Silva, Kalil Filho Roberto, Jatene Fabio Biscegli, Hajjar Ludhmila Abrahão

机构信息

Intensive Care Unit, Cancer Institute (ICESP), University of Sao Paulo, São Paulo, Brazil.

Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.

出版信息

Ann Intensive Care. 2021 Jan 26;11(1):15. doi: 10.1186/s13613-021-00808-6.

DOI:10.1186/s13613-021-00808-6

PMID:33496877

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7838231/

Abstract

BACKGROUND

The detrimental effects of inotropes are well-known, and in many fields they are only used within a goal-directed therapy approach. Nevertheless, standard management in many centers includes administering inotropes to all patients undergoing cardiac surgery to prevent low cardiac output syndrome and its implications. Randomized evidence in favor of a patient-tailored, inotrope-sparing approach is still lacking. We designed a randomized controlled noninferiority trial in patients undergoing cardiac surgery with normal ejection fraction to assess whether an dobutamine-sparing strategy (in which the use of dobutamine was guided by hemodynamic evidence of low cardiac output associated with signs of inadequate tissue perfusion) was noninferior to an inotrope-to-all strategy (in which all patients received dobutamine).

RESULTS

A total of 160 patients were randomized to the dobutamine-sparing strategy (80 patients) or to the dobutamine-to-all approach (80 patients). The primary composite endpoint of 30-day mortality or occurrence of major cardiovascular complications (arrhythmias, acute myocardial infarction, low cardiac output syndrome and stroke or transient ischemic attack) occurred in 25/80 (31%) patients of the dobutamine-sparing group (p = 0.74) and 27/80 (34%) of the dobutamine-to-all group. There were no significant differences between groups regarding the incidence of acute kidney injury, prolonged mechanical ventilation, intensive care unit or hospital length of stay.

DISCUSSION

Although it is common practice in many centers to administer inotropes to all patients undergoing cardiac surgery, a dobutamine-sparing strategy did not result in an increase of mortality or occurrence of major cardiovascular events when compared to a dobutamine-to-all strategy. Further research is needed to assess if reducing the administration of inotropes can improve outcomes in cardiac surgery. Trial registration ClinicalTrials.gov, NCT02361801. Registered Feb 2nd, 2015. https://clinicaltrials.gov/ct2/show/NCT02361801.

摘要

背景

正性肌力药物的有害作用众所周知，在许多领域中，它们仅在目标导向治疗方法中使用。然而，许多中心的标准管理包括对所有接受心脏手术的患者使用正性肌力药物，以预防低心排血量综合征及其相关影响。目前仍缺乏支持针对患者量身定制的、减少正性肌力药物使用方法的随机证据。我们设计了一项针对射血分数正常的心脏手术患者的随机对照非劣效性试验，以评估多巴酚丁胺保留策略（即根据与组织灌注不足体征相关的低心排血量血流动力学证据来指导多巴酚丁胺的使用）是否不劣于对所有患者使用正性肌力药物的策略（即所有患者均接受多巴酚丁胺）。

结果

共有160例患者被随机分为多巴酚丁胺保留策略组（80例患者）或对所有患者使用多巴酚丁胺组（80例患者）。多巴酚丁胺保留组25/80（31%）的患者出现了30天死亡率或主要心血管并发症（心律失常、急性心肌梗死、低心排血量综合征以及中风或短暂性脑缺血发作）这一主要复合终点事件（p = 0.74），而在对所有患者使用多巴酚丁胺组中这一比例为27/80（34%）。两组在急性肾损伤发生率、机械通气时间延长、重症监护病房住院时间或总住院时间方面无显著差异。

讨论

尽管在许多中心对所有接受心脏手术的患者使用正性肌力药物是常见做法，但与对所有患者使用多巴酚丁胺的策略相比，多巴酚丁胺保留策略并未导致死亡率增加或主要心血管事件的发生。需要进一步研究以评估减少正性肌力药物的使用是否能改善心脏手术的预后。试验注册ClinicalTrials.gov，NCT02361801。于2015年2月2日注册。https://clinicaltrials.gov/ct2/show/NCT02361801 。