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Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery

NCT ID: NCT04602767

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2024-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vasopressin

Low dose vasopressin as first line vasopressor in cardiac surgery.

Group Type EXPERIMENTAL

Vasopressin

Intervention Type DRUG

Vasopressin titrated 0.01 U/min up to 0.04 U/min for MAP \< 65 mmHg

Phenylephrine

Low dose phenylephrine as first line vasopressor in cardiac surgery

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type DRUG

Phenylephrine titrated 0.25 mcg/kg/min up to 1.0 mcg/kg/min for MAP \< 65 mmHg

Interventions

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Vasopressin

Vasopressin titrated 0.01 U/min up to 0.04 U/min for MAP \< 65 mmHg

Intervention Type DRUG

Phenylephrine

Phenylephrine titrated 0.25 mcg/kg/min up to 1.0 mcg/kg/min for MAP \< 65 mmHg

Intervention Type DRUG

Other Intervention Names

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Pitressin Neosynephrine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Jordan Goldhammer

Associate Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Thomas Jefferson Univesity

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jenifer Lessin

Role: CONTACT

[email protected]
215 955-5804

Facility Contacts

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Jordan Goldhammer, MD

Role: primary

[email protected]

Other Identifiers

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20D.847

Identifier Type: -

Identifier Source: org_study_id

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