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Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery

Primary Purpose

Acute Kidney Injury

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vasopressin
Phenylephrine
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Thomas Jefferson UnivesityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vasopressin

Phenylephrine

Arm Description

Low dose vasopressin as first line vasopressor in cardiac surgery.

Low dose phenylephrine as first line vasopressor in cardiac surgery

Outcomes

Primary Outcome Measures

Number of patients with acute kidney injury
KDIGO criteria

Secondary Outcome Measures

Number of patients with 30-Day Mortality
Number of patients with 30-Day Mortality
Number of patients with reoperation
Number of patients with reoperation
Number of patients with sternal Infection
Number of patients with sternal Infection
Number of patients with Atrial Fibrilation
Number of patients with Atrial Fibrilation
ICU Length of Stay
Total ICU Length of Stay
Total Vasopressor Hours
Total Vasopressor Hours

Full Information

First Posted
October 20, 2020
Last Updated
June 6, 2023
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT04602767
Brief Title
Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery
Official Title
Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
September 29, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thomas Jefferson University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vasopressin
Arm Type
Experimental
Arm Description
Low dose vasopressin as first line vasopressor in cardiac surgery.
Arm Title
Phenylephrine
Arm Type
Experimental
Arm Description
Low dose phenylephrine as first line vasopressor in cardiac surgery
Intervention Type
Drug
Intervention Name(s)
Vasopressin
Other Intervention Name(s)
Pitressin
Intervention Description
Vasopressin titrated 0.01 U/min up to 0.04 U/min for MAP < 65 mmHg
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
Neosynephrine
Intervention Description
Phenylephrine titrated 0.25 mcg/kg/min up to 1.0 mcg/kg/min for MAP < 65 mmHg
Primary Outcome Measure Information:
Title
Number of patients with acute kidney injury
Description
KDIGO criteria
Time Frame
5 Days
Secondary Outcome Measure Information:
Title
Number of patients with 30-Day Mortality
Description
Number of patients with 30-Day Mortality
Time Frame
30 Days
Title
Number of patients with reoperation
Description
Number of patients with reoperation
Time Frame
5 Days
Title
Number of patients with sternal Infection
Description
Number of patients with sternal Infection
Time Frame
5 Days
Title
Number of patients with Atrial Fibrilation
Description
Number of patients with Atrial Fibrilation
Time Frame
5 Days
Title
ICU Length of Stay
Description
Total ICU Length of Stay
Time Frame
5 Days
Title
Total Vasopressor Hours
Description
Total Vasopressor Hours
Time Frame
5 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenifer Lessin
Phone
215 955-5804
Email
jennifer.lessin@jefferson.edu
Facility Information:
Facility Name
Thomas Jefferson Univesity
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Goldhammer, MD
Email
jordan.goldhammer@jefferson.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery

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