Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: Vasopressin; Drug: Phenylephrine

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jenifer Lessin; Phone Number: 215 955-5804; Email: jennifer.lessin@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19146
      • Recruiting
      • Thomas Jefferson Univesity
      • Contact: Jordan Goldhammer, MD; Email: jordan.goldhammer@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vasopressin; Low dose vasopressin as first line vasopressor in cardiac surgery.	Drug: Vasopressin; Vasopressin titrated 0.01 U/min up to 0.04 U/min for MAP < 65 mmHg; Other Names: Pitressin
Experimental: Phenylephrine; Low dose phenylephrine as first line vasopressor in cardiac surgery	Drug: Phenylephrine; Phenylephrine titrated 0.25 mcg/kg/min up to 1.0 mcg/kg/min for MAP < 65 mmHg; Other Names: Neosynephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with acute kidney injury	KDIGO criteria	5 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with 30-Day Mortality	Number of patients with 30-Day Mortality	30 Days
Number of patients with reoperation	Number of patients with reoperation	5 Days
Number of patients with sternal Infection	Number of patients with sternal Infection	5 Days
Number of patients with Atrial Fibrilation	Number of patients with Atrial Fibrilation	5 Days
ICU Length of Stay	Total ICU Length of Stay	5 Days
Total Vasopressor Hours	Total Vasopressor Hours	5 Days

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Estimated): May 29, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Natriuretic Agents; Cardiotonic Agents; Respiratory System Agents; Hemostatics; Coagulants; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Antidiuretic Agents; Adrenergic alpha-1 Receptor Agonists; Vasopressins; Arginine Vasopressin; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: 20D.847

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No