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心脏指数指导治疗以维持高危行大型开腹手术患者诱导后优化的心脏指数:多中心随机 iPEGASUS 试验。

Cardiac index-guided therapy to maintain optimised postinduction cardiac index in high-risk patients having major open abdominal surgery: the multicentre randomised iPEGASUS trial.

机构信息

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

Department of Anesthesiology, Operative Intensive Care and Pain Therapy, Justus-Liebig-University Giessen, Giessen, Germany.

出版信息

Br J Anaesth. 2024 Aug;133(2):277-287. doi: 10.1016/j.bja.2024.03.040. Epub 2024 May 26.

DOI:10.1016/j.bja.2024.03.040
PMID:38797635
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11282469/
Abstract

BACKGROUND

It is unclear whether optimising intraoperative cardiac index can reduce postoperative complications. We tested the hypothesis that maintaining optimised postinduction cardiac index during and for the first 8 h after surgery reduces the incidence of a composite outcome of complications within 28 days after surgery compared with routine care in high-risk patients having elective major open abdominal surgery.

METHODS

In three German and two Spanish centres, high-risk patients having elective major open abdominal surgery were randomised to cardiac index-guided therapy to maintain optimised postinduction cardiac index (cardiac index at which pulse pressure variation was <12%) during and for the first 8 h after surgery using intravenous fluids and dobutamine or to routine care. The primary outcome was the incidence of a composite outcome of moderate or severe complications within 28 days after surgery.

RESULTS

We analysed 318 of 380 enrolled subjects. The composite primary outcome occurred in 84 of 152 subjects (55%) assigned to cardiac index-guided therapy and in 77 of 166 subjects (46%) assigned to routine care (odds ratio: 1.87, 95% confidence interval: 1.03-3.39, P=0.038). Per-protocol analyses confirmed the results of the primary outcome analysis.

CONCLUSIONS

Maintaining optimised postinduction cardiac index during and for the first 8 h after surgery did not reduce, and possibly increased, the incidence of a composite outcome of complications within 28 days after surgery compared with routine care in high-risk patients having elective major open abdominal surgery. Clinicians should not strive to maintain optimised postinduction cardiac index during and after surgery in expectation of reducing complications.

CLINICAL TRIAL REGISTRATION

NCT03021525.

摘要

背景

目前尚不清楚优化术中心指数是否能减少术后并发症。我们检验了这样一个假设,即在择期开腹大手术的高危患者中,与常规护理相比,在手术期间和术后 8 小时内维持优化的诱导后心指数(脉压变异<12%时的心脏指数)可以降低术后 28 天内复合并发症的发生率。

方法

在三个德国和两个西班牙中心,择期开腹大手术的高危患者被随机分配到心指数指导治疗组,以维持术中及术后 8 小时内优化的诱导后心指数(当脉压变异<12%时的心脏指数),使用静脉输液和多巴酚丁胺,或常规护理。主要结局是术后 28 天内中度或重度并发症的复合发生率。

结果

我们分析了 380 名入组患者中的 318 名。心指数指导治疗组 152 名患者中有 84 名(55%)和常规护理组 166 名患者中有 77 名(46%)发生了复合主要结局(比值比:1.87,95%置信区间:1.03-3.39,P=0.038)。按方案分析证实了主要结局分析的结果。

结论

与常规护理相比,在择期开腹大手术的高危患者中,在手术期间和术后 8 小时内维持优化的诱导后心指数并不能降低,而且可能增加术后 28 天内复合并发症的发生率。临床医生不应期望通过维持手术期间和手术后的优化诱导后心指数来降低并发症的发生率。

临床试验注册

NCT03021525。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f39/11282469/9b364636b1ab/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f39/11282469/479eb06b0118/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f39/11282469/50d6d4f979b2/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f39/11282469/9b364636b1ab/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f39/11282469/479eb06b0118/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f39/11282469/50d6d4f979b2/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f39/11282469/9b364636b1ab/gr3.jpg

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