右美托咪定降低感染性休克患者死亡率的随机对照试验（DecatSepsis）。

Dexmedetomidine for Reducing Mortality in Patients With Septic Shock: A Randomized Controlled Trial (DecatSepsis).

作者信息

Ezz Al-Regal Ahmed Ragab, Ramzy Eyad Ahmed, Atia Amer Abd Allah, Emara Moataz Maher

机构信息

Department of Anesthesiology and Intensive Care and Pain Medicine, Faculty of Medicine, Mansoura University, Mansoura, Egypt.

出版信息

Chest. 2024 Dec;166(6):1394-1405. doi: 10.1016/j.chest.2024.06.3794. Epub 2024 Jul 14.

DOI:10.1016/j.chest.2024.06.3794

PMID:39004217

Abstract

BACKGROUND

Sepsis, especially septic shock, and its complications have been linked to the hyperadrenergic stress response.

RESEARCH QUESTION

Does decatecholaminization with dexmedetomidine lower the in-hospital mortality in patients with septic shock?

STUDY DESIGN AND METHODS

This open-label randomized controlled trial assessed the effects of a heart rate (HR)-calibrated dexmedetomidine infusion on in-hospital mortality in patients with septic shock and HR of > 90 beats/min, regardless of whether they are receiving mechanical ventilation. Dexmedetomidine was infused for 48 h to maintain the HR at 60 to 90 beats/min. Mechanically ventilated patients received conventional sedation in both groups. Other outcomes were the norepinephrine equivalent dose, the need for additional vasopressor, Acute Physiology and Chronic Health Evaluation (APACHE) II score, persistent atrial fibrillation (AF), and C-reactive protein (CRP) level.

RESULTS

In 90 patients of either sex, dexmedetomidine reduced the mean HR over the first 3 days in the ICU by 11.2 beats/min (95% CI, -17 to -5 beats/min; P < .001). The in-hospital mortality risk ratio (RR) was 0.68 (95% CI, 0.43-1.07; P = .091). The dexmedetomidine group received a norepinephrine equivalent dose of 0.55 μm/kg/min (interquartile range [IQR], 0.37-0.82 μm/kg/min) vs 0.61 μm/kg/min (IQR, 0.47-0.89 μm/kg/min; P = .121). Dexmedetomidine reduced the epinephrine infusion rescue (relative risk reduction, 0.6; 95% CI, 0.06-0.93; P = .025). The RR of persistent AF was 0.47 (95% CI, 0.21-0.99; P = .05). Dexmedetomidine reduced the median APACHE II score on the third day by -6 (95% CI, -10 to -2; P = .003) and the mean CRP concentration by -40 mg/dL (95% CI, -78 to -3.4 mg/dL; P = .033).

INTERPRETATION

The study was underpowered to detect a reduction in in-hospital mortality or norepinephrine equivalent dose in patients with septic shock with dexmedetomidine. However, dexmedetomidine may reduce epinephrine infusion rescue, persistent AF, APACHE II score, and CRP.

CLINICAL TRIAL REGISTRY

ClinicalTrials.gov; No.: NCT05283083; URL: www.

CLINICALTRIALS

gov.

摘要

背景

脓毒症，尤其是脓毒性休克及其并发症与高肾上腺素能应激反应有关。

研究问题

右美托咪定去甲肾上腺素化是否能降低脓毒性休克患者的院内死亡率？

研究设计与方法

这项开放标签随机对照试验评估了心率（HR）校准的右美托咪定输注对脓毒性休克且心率>90次/分钟患者的院内死亡率的影响，无论他们是否接受机械通气。右美托咪定输注48小时以将心率维持在60至90次/分钟。两组机械通气患者均接受常规镇静。其他结局指标包括去甲肾上腺素等效剂量、额外血管升压药的需求、急性生理与慢性健康状况评估（APACHE）II评分、持续性心房颤动（AF）以及C反应蛋白（CRP）水平。

结果

在90例患者中，无论性别，右美托咪定使ICU内前3天的平均心率降低了11.2次/分钟（95%CI，-17至-5次/分钟；P<.001）。院内死亡风险比（RR）为0.68（95%CI，0.43 - 1.07；P = .091）。右美托咪定组接受的去甲肾上腺素等效剂量为0.55μg/kg/分钟（四分位间距[IQR]，0.37 - 0.82μg/kg/分钟），而另一组为0.61μg/kg/分钟（IQR，0.47 - 0.89μg/kg/分钟；P = .121）。右美托咪定减少了肾上腺素输注抢救（相对风险降低，0.6；95%CI，0.06 - 0.93；P = .025）。持续性AF的RR为0.47（95%CI，0.21 - 0.99；P = .05）。右美托咪定使第3天的APACHE II评分中位数降低了-6（95%CI，-10至-2；P = .003），并使平均CRP浓度降低了-40mg/dL（95%CI，-78至-3.4mg/dL；P = .033）。