Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery

Thomas Jefferson University

Status and phase: Enrolling; Phase 4

Conditions: Acute Kidney Injury

Treatments: Drug: Phenylephrine; Drug: Vasopressin

Study type: Interventional

Funder types: Other

Identifiers

NCT04602767

20D.847

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Vasopressin

Experimental group

Description:

Low dose vasopressin as first line vasopressor in cardiac surgery.

Treatment:

Drug: Vasopressin

Phenylephrine

Experimental group

Description:

Low dose phenylephrine as first line vasopressor in cardiac surgery

Treatment:

Drug: Phenylephrine