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临床试验/NCT04602767
NCT04602767招募中4 期

Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery

Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年10月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
300
试验地点
1
主要终点
Number of patients with acute kidney injury

研究概览

简要总结

This is a randomized, open label study to investigate vasopressin versus phenylephrine as a first line pressor in cardiac surgery. All patients >18 years of age presenting for coronary artery bypass graft (CABG), valve surgery, or combined CABG and valve surgery will be screened for inclusion. Patients with ejection fraction < 35%, > moderate pulmonary hypertension, > mild right ventricular dysfunction, a planned radial arterial graft, or circulatory arrest will be excluded. Patients will be randomized to receive either vasopressin or phenylephrine as the first line vasopressor during the perioperative period to maintain mean arterial blood pressure >65 mmhg. Primary outcome is acute kidney injury. Secondary outcomes are 30-day mortality, stroke, myocardial infarction, re-operation, sternal infection, atrial fibrillation, intensive care unit length of stay, and total vasopressor hours.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • >18 years of age
  • Coronary artery bypass graft (CABG), valve, or combined CABG and valve surgery

排除标准

  • Ejection fraction < 35%
  • > moderate pulmonary hypertension
  • > mild right ventricular dysfunction
  • Radial arterial graft
  • Circulatory arrest

研究组 & 干预措施

Vasopressin

Experimental

Low dose vasopressin as first line vasopressor in cardiac surgery.

干预措施: Vasopressin (Drug)

Phenylephrine

Experimental

Low dose phenylephrine as first line vasopressor in cardiac surgery

干预措施: Phenylephrine (Drug)

结局指标

主要结局

Number of patients with acute kidney injury

时间窗: 5 Days

KDIGO criteria

次要结局

  • Number of patients with 30-Day Mortality(30 Days)
  • Number of patients with reoperation(5 Days)
  • Number of patients with sternal Infection(5 Days)
  • Number of patients with Atrial Fibrilation(5 Days)
  • ICU Length of Stay(5 Days)
  • Total Vasopressor Hours(5 Days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jordan Goldhammer

Associate Professor of Anesthesiology

Thomas Jefferson University

研究点 (1)

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