Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery

Phase 4

Recruiting

• Conditions: Acute Kidney Injury
• Interventions: Drug: Vasopressin; Drug: Phenylephrine

• Registration Number: NCT04602767
• Lead Sponsor: Thomas Jefferson University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-15
• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-29
• Primary Completion: 2024-05-29
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vasopressin	Vasopressin	Low dose vasopressin as first line vasopressor in cardiac surgery.
Phenylephrine	Phenylephrine	Low dose phenylephrine as first line vasopressor in cardiac surgery

Primary Outcome Measures

Name	Time	Method
Number of patients with acute kidney injury	5 Days	KDIGO criteria

Secondary Outcome Measures

Name	Time	Method
Number of patients with 30-Day Mortality	30 Days	Number of patients with 30-Day Mortality
Number of patients with reoperation	5 Days	Number of patients with reoperation
Number of patients with sternal Infection	5 Days	Number of patients with sternal Infection
Number of patients with Atrial Fibrilation	5 Days	Number of patients with Atrial Fibrilation
ICU Length of Stay	5 Days	Total ICU Length of Stay
Total Vasopressor Hours	5 Days	Total Vasopressor Hours

Trial Locations

Locations (1)

Thomas Jefferson Univesity; 🇺🇸 Philadelphia, Pennsylvania, United States