BMJ. 2024 Dec 3;387:e080439. doi: 10.1136/bmj-2024-080439.
To evaluate the clinical effectiveness and safety of a perioperative algorithm for cardiac output-guided haemodynamic therapy in patients undergoing major gastrointestinal surgery.
Multicentre randomised controlled trial.
Surgical services of 55 hospitals worldwide.
2498 adults aged ≥65 years with an American Society of Anesthesiologists physical status classification of II or greater and undergoing major elective gastrointestinal surgery, recruited between January 2017 and September 2022.
Participants were assigned to minimally invasive cardiac output-guided intravenous fluid therapy with low dose inotrope infusion during and four hours after surgery, or to usual care without cardiac output monitoring.
The primary outcome was postoperative infection within 30 days of randomisation. Safety outcomes were acute cardiac events within 24 hours and 30 days. Secondary outcomes were acute kidney injury within 30 days and mortality within 180 days.
In 2498 patients (mean age 74 (standard deviation 6) years, 57% women), the primary outcome occurred in 289/1247 (23.2%) intervention patients and 283/1247 (22.7%) usual care patients (adjusted odds ratio 1.03 (95% confidence interval 0.84 to 1.25); P=0.81). Acute cardiac events within 24 hours occurred in 38/1250 (3.0%) intervention patients and 21/1247 (1.7%) usual care patients (adjusted odds ratio 1.82 (1.06 to 3.13); P=0.03). This difference was primarily due to an increased incidence of arrhythmias among intervention patients. Acute cardiac events within 30 days occurred in 85/1249 (6.8%) intervention patients and 79/1247 (6.3%) usual care patients (adjusted odds ratio 1.06 (0.77 to 1.47); P=0.71). Other secondary outcomes did not differ.
This clinical effectiveness trial in patients undergoing major elective gastrointestinal surgery did not provide evidence that cardiac output-guided intravenous fluid therapy with low dose inotrope infusion could reduce the incidence of postoperative infections. The intervention was associated with an increased incidence of acute cardiac events within 24 hours, in particular tachyarrhythmias. Based on these findings, the routine use of this treatment approach in unselected patients is not recommended.
ISRCTN Registry ISRCTN39653756.
评估围手术期心输出量指导的血流动力学治疗方案在接受大型胃肠道手术患者中的临床有效性和安全性。
多中心随机对照试验。
全球55家医院的外科服务部门。
2498名年龄≥65岁、美国麻醉医师协会身体状况分级为II级或更高且接受大型择期胃肠道手术的成年人，于2017年1月至2022年9月招募。
参与者被分配接受微创手术中的心输出量指导的静脉输液治疗，并在手术期间及术后4小时给予低剂量血管活性药物输注，或接受不进行心输出量监测的常规护理。
主要结局为随机分组后30天内的术后感染。安全结局为24小时内和30天内的急性心脏事件。次要结局为30天内的急性肾损伤和180天内的死亡率。
在2498例患者（平均年龄74（标准差6）岁，57%为女性）中，主要结局发生在289/1247（23.2%）例干预组患者和283/1247（22.7%）例常规护理组患者中（调整后的优势比为1.03（95%置信区间0.84至1.25）；P = 0.81）。24小时内的急性心脏事件发生在38/1250（3.0%）例干预组患者和21/1247（1.7%）例常规护理组患者中（调整后的优势比为1.82（1.06至3.13）；P = 0.03）。这种差异主要是由于干预组患者心律失常的发生率增加。30天内的急性心脏事件发生在85/1249（6.8%）例干预组患者和79/1247（6.3%）例常规护理组患者中（调整后的优势比为1.06（0.77至1.47）；P = 0.71）。其他次要结局无差异。
这项针对接受大型择期胃肠道手术患者的临床有效性试验没有提供证据表明心输出量指导的静脉输液治疗并给予低剂量血管活性药物输注可以降低术后感染的发生率。该干预措施与24小时内急性心脏事件发生率增加有关，尤其是快速性心律失常。基于这些发现，不建议在未选择的患者中常规使用这种治疗方法。
ISRCTN注册中心ISRCTN39653756
