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Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT04602767
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Jordan Goldhammer, Thomas Jefferson University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: Vasopressin Drug: Phenylephrine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery
Actual Study Start Date : October 15, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arms and Interventions
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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 Name: Pitressin
Experimental: Phenylepherine
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 Name: Neosynephrine


Outcome Measures
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Primary Outcome Measures :
  1. Acute Kidney Injury [ Time Frame: 5 Days ]
    KDIGO criteria


Secondary Outcome Measures :
  1. 30-Day Mortality [ Time Frame: 30 Days ]
  2. Reoperation [ Time Frame: 5 Days ]
  3. Sternal Infection [ Time Frame: 5 Days ]
  4. Atrial Fibrilation [ Time Frame: 5 Days ]
  5. ICU Length of Stay [ Time Frame: 5 Days ]
  6. Total Vasopressor Hours [ Time Frame: 5 Days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with ejection fraction < 35%, > moderate pulmonary hypertension, > mild right ventricular dysfunction, a planned radial arterial graft, or circulatory arrest will be excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602767


Contacts
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Contact: Jenifer Lessin 215 955-5804 jennifer.lessin@jefferson.edu

Locations
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United States, Pennsylvania
Thomas Jefferson Univesity Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Jordan Goldhammer, MD       jordan.goldhammer@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
More Information
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Responsible Party: Jordan Goldhammer, MD, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT04602767    
Other Study ID Numbers: 20D.847
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Phenylephrine
Vasopressins
Arginine Vasopressin
Oxymetazoline
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
 Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents