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围手术期口服咖啡因不能预防体外循环心脏瓣膜手术后的心房颤动:一项随机对照临床试验。

Peri-operative oral caffeine does not prevent postoperative atrial fibrillation after heart valve surgery with cardiopulmonary bypass: A randomised controlled clinical trial.

机构信息

From the Department of Anaesthesia and Intensive Care Medicine (DL, LN, FK, NB, LV, CG), Department of Biochemistry (RG, EF), Department of Biostatistics (NR, RG), Department of Cardiac Surgery (AT, DG, VG), La Timone University Hospital, Aix-Marseille University, Marseille, France (FC).

出版信息

Eur J Anaesthesiol. 2018 Dec;35(12):911-918. doi: 10.1097/EJA.0000000000000824.

DOI:10.1097/EJA.0000000000000824
PMID:29702502
Abstract

BACKGROUND

Raised plasma levels of endogenous adenosine after cardiac surgery using cardiopulmonary bypass (CPB) have been related to the incidence of postoperative atrial fibrillation (POAF).

OBJECTIVE

We wished to assess if caffeine, an adenosine receptor antagonist could have a beneficial effect on the incidence of POAF.

DESIGN

A randomised controlled study.

SETTING

Single University Hospital.

PATIENTS

One hundred and ten patients scheduled for heart valve surgery with CPB.

INTERVENTIONS

We randomly assigned patients to receive peri-operative oral caffeine (400 mg every 8 h for 2 days) or placebo. Adenosine plasma concentrations and caffeine pharmacokinetic profile were evaluated in a subgroup of 50 patients.

MAIN OUTCOME MEASURES

The primary endpoint was the rate of atrial fibrillation during postoperative hospital stay.

RESULTS

The current study was stopped for futility by the data monitoring board after an interim analysis. The incidence of atrial fibrillation was similar in the caffeine and in the placebo group during hospital stay (33 vs. 29%, P = 0.67) and the first 3 postoperative days (18 vs. 15%; P = 0.60). Basal and postoperative adenosine plasma levels were significantly associated with the primary outcome. Adenosine plasma levels were similar in the two treatment groups. Caffeine administration was associated with a higher incidence of postoperative nausea and vomiting (27 vs. 7%, P = 0.005).

CONCLUSION

Oral caffeine does not prevent POAF after heart valve surgery with CPB but increased the incidence of postoperative nausea and vomiting.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, no.: NCT01999829.

摘要

背景

体外循环(CPB)心脏手术后内源性腺苷水平升高与术后心房颤动(POAF)的发生有关。

目的

我们希望评估咖啡因(一种腺苷受体拮抗剂)是否对 POAF 的发生率有有益影响。

设计

随机对照研究。

设置

单所大学医院。

患者

110 例拟行 CPB 心脏瓣膜手术的患者。

干预措施

我们将患者随机分配接受围手术期口服咖啡因(400mg,每 8 小时一次,持续 2 天)或安慰剂。在 50 例患者的亚组中评估了腺苷血浆浓度和咖啡因药代动力学特征。

主要观察指标

主要终点是术后住院期间心房颤动的发生率。

结果

中期分析后,数据监测委员会认为该研究因无效而停止。在住院期间(33%比 29%,P=0.67)和术后前 3 天(18%比 15%,P=0.60),咖啡因组和安慰剂组的心房颤动发生率相似。基础和术后腺苷血浆水平与主要结局显著相关。两组患者的腺苷血浆水平相似。咖啡因给药与术后恶心和呕吐的发生率增加相关(27%比 7%,P=0.005)。

结论

CPB 心脏手术后口服咖啡因不能预防 POAF,但会增加术后恶心和呕吐的发生率。

临床试验注册

ClinicalTrials.gov,编号:NCT01999829。

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