多中心随机试验（IMPROVE-multi）方案：个体化围手术期血压管理对高危患者大型腹部手术后术后并发症和死亡率的影响。

Effect of personalized perioperative blood pressure management on postoperative complications and mortality in high-risk patients having major abdominal surgery: protocol for a multicenter randomized trial (IMPROVE-multi).

机构信息

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.

Department of Anaesthesiology, University Hospital LMU Munich, Munich, Germany.

出版信息

Trials. 2022 Nov 17;23(1):946. doi: 10.1186/s13063-022-06854-0.

DOI:10.1186/s13063-022-06854-0

PMID:36397173

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9670085/

Abstract

BACKGROUND

Intraoperative hypotension is common in patients having non-cardiac surgery and is associated with serious complications and death. However, optimal intraoperative blood pressures for individual patients remain unknown. We therefore aim to test the hypothesis that personalized perioperative blood pressure management-based on preoperative automated blood pressure monitoring-reduces the incidence of a composite outcome of acute kidney injury, acute myocardial injury, non-fatal cardiac arrest, and death within 7 days after surgery compared to routine blood pressure management in high-risk patients having major abdominal surgery.

METHODS

IMPROVE-multi is a multicenter randomized trial in 1272 high-risk patients having elective major abdominal surgery that we plan to conduct at 16 German university medical centers. Preoperative automated blood pressure monitoring using upper arm cuff oscillometry will be performed in all patients for one night to obtain the mean of the nighttime mean arterial pressures. Patients will then be randomized either to personalized blood pressure management or to routine blood pressure management. In patients assigned to personalized management, intraoperative mean arterial pressure will be maintained at least at the mean of the nighttime mean arterial pressures. In patients assigned to routine management, intraoperative blood pressure will be managed per routine. The primary outcome will be a composite of acute kidney injury, acute myocardial injury, non-fatal cardiac arrest, and death within 7 days after surgery.

DISCUSSION

Our trial will determine whether personalized perioperative blood pressure management reduces the incidence of major postoperative complications and death within 7 days after surgery compared to routine blood pressure management in high-risk patients having major abdominal surgery.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05416944. Registered on June 14, 2022.

摘要

背景

术中低血压在非心脏手术患者中很常见，与严重并发症和死亡有关。然而，个体患者的最佳术中血压仍不清楚。因此，我们旨在检验以下假设：与常规血压管理相比，基于术前自动血压监测的个体化围手术期血压管理可降低高危患者接受大型腹部手术后 7 天内急性肾损伤、急性心肌损伤、非致命性心脏骤停和死亡的复合结局发生率。

方法

IMPROVE-multi 是一项在 1272 例接受择期大型腹部手术的高危患者中进行的多中心随机试验，我们计划在 16 家德国大学医学中心开展。所有患者将进行一晚上的上臂袖带振荡法术前自动血压监测，以获得夜间平均动脉压的平均值。然后，患者将被随机分为个体化血压管理组或常规血压管理组。在接受个体化管理的患者中，术中平均动脉压将至少维持在夜间平均动脉压的平均值。在接受常规管理的患者中，术中血压将按照常规进行管理。主要结局为术后 7 天内发生急性肾损伤、急性心肌损伤、非致命性心脏骤停和死亡的复合结局。