跳至主要内容
临床试验/NCT05914090
NCT05914090尚未招募不适用

The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in Adult: a Stepped Wedge Cluster Randomized Trial

Yan Fuxia1 个研究点 分布在 1 个国家目标入组 3,600 人开始时间: 2023年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
3,600
试验地点
1
主要终点
Composite outcomes

研究概览

简要总结

Among adults, patients undergoing elective extracorporeal circulation for cardiac surgery are included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative oral intake of multidimensional carbohydrate beverages, multimodal analgesia, blood protection strategies, correction of perioperative hypoalbuminemia, early removal of tracheal intubation, maintenance of blood sugar at reasonable levels, and targeted liquid therapy. The traditional plan group follows the current clinical diagnosis and treatment routine. By comparing the differences in the incidence of major postoperative outcomes (MACCE events, major pulmonary complications, and acute kidney injury) between the intervention group and the non intervention group, as well as comparing other adverse events (including but not limited to pneumonia, massive bleeding, postoperative arrhythmia, incision infection, postoperative nausea, vomiting, and delirium), all cause secondary intubation, and all cause secondary surgery between the two groups, and recording hospitalization time, ICU stay time The removal time of tracheal intubation and drainage tube, as well as the pain score during hospitalization and the total amount of opioid drug use (converted to equivalent dose morphine), hospitalization cost, postoperative recovery quality QoR15 scale score, and patient satisfaction score, were recorded to explore whether the ERAS regimen can reduce the incidence of major postoperative adverse events, improve patient prognosis, and accelerate postoperative recovery compared to traditional regimens.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 to 80 years
  • Patients awaiting elective cardiac surgery with cardiopulmonary bypass (CPB)

排除标准

  • American Society of Anesthesiologists (ASA) class is above class V
  • Patients with cardiac assist device or mechanical ventilation
  • The ejection fraction of patients is less than 30%
  • Patients with morbid obesity
  • Patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS)
  • Patients with severe pulmonary disease, including severe chronic obstructive pulmonary disease (COPD) or respiratory failure
  • Patients with severe liver or renal dysfunction, including severe acute or chronic renal dysfunction need renal replacement therapy, and acute or chronic liver failure need artificial liver therapy
  • Patients with long-term opioid or sedative utilization
  • Patients with a history of alcohol or cigarette abuse
  • Patients with long-term hormone therapy
  • An international normalized ratio > 2.0
  • Patients with severe malnutrition
  • Mental or legal disability
  • Current enrollment in another clinical trial
  • Patients' refusal or low adherence

结局指标

主要结局

Composite outcomes

时间窗: during hospitalization, an average of 1 week, assessed up to 30 days

The composite outcomes include the major adverse cardiac and cerebrovascular events (MACCE), major postoperative pulmonary complication (PPCs), and acute kidney injury (AKI).

次要结局

  • cumulative opioid dosage(during hospitalization, an average of 1 week, assessed up to 30 days)
  • the duration of intensive care unit (ICU) stay(Time from ICU admission to ICU discharge, assessed up to 30 days)
  • the quality of recovery score (QoR)-15 after surgery(At 24 hour after surgery)
  • length of hospital stay(From the date of admission until the date of discharging, assessed up to 30 days)
  • time to extubation(The time from the end of operation to the removal of tracheal intubation, assessed up to 30 days)
  • overall medical costs(during hospitalization, an average of 1 week, assessed up to 30 days)
  • satisfaction score(the day before discharge, assessed up to 30 days)
  • time to drainage removal(The time from the end of operation to the removal of drainage tube, assessed up to 30 days)
  • the rate of other complications(during hospitalization, an average of 1 week, assessed up to 30 days)
  • the rate of reintubation for any cause(during hospitalization, an average of 1 week, assessed up to 30 days)
  • the outcomes of long-term prognosis by telephone follow-up(within 30 days, 3 months, and 1 year)

研究者

发起方
Yan Fuxia
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yan Fuxia

principal investigator

Chinese Academy of Medical Sciences, Fuwai Hospital

研究点 (1)

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