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Vasopressor
Vasopressin vs Phenylephrine for Preventing Kidney Injury During Cardiac Surgery
Phase 4
Recruiting
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Summary
This trial compares two drugs to maintain blood pressure during cardiac surgery. Primary outcome is kidney injury; secondary outcomes include mortality, stroke, etc.
Who is the study for?
Adults over 18 years old who are undergoing coronary artery bypass graft, valve surgery, or both can join this trial. It's not for those with severe heart pump issues (ejection fraction <35%), significant lung blood pressure problems, certain heart muscle dysfunction, planned use of a radial artery in the surgery, or if they need to stop their circulation during the operation.
What is being tested?
The study is comparing two drugs—Vasopressin and Phenylephrine—to see which one is better at preventing kidney injury when used as the first choice drug to maintain blood pressure during and after heart surgery. Participants will be randomly assigned to one of these treatments.
What are the potential side effects?
Possible side effects from Vasopressin include chest pain, fast heartbeat, skin paleness while Phenylephrine may cause headache, high blood pressure, and reflex bradycardia (slowing down of the heart).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of patients with acute kidney injury
Secondary study objectives
ICU Length of Stay
Number of patients with 30-Day Mortality
Number of patients with Atrial Fibrilation
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: VasopressinExperimental Treatment1 Intervention
Low dose vasopressin as first line vasopressor in cardiac surgery.
Group II: PhenylephrineExperimental Treatment1 Intervention
Low dose phenylephrine as first line vasopressor in cardiac surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vasopressin
FDA approved
Phenylephrine
FDA approved
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
457 Previous Clinical Trials
149,876 Total Patients Enrolled
1 Trials studying Acute Kidney Injury
450 Patients Enrolled for Acute Kidney Injury
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are 18 or older and have had a coronary artery bypass graft (CABG), valve, or combined CABG and valve surgery.You have had surgery to use a blood vessel from your arm called the radial artery.You have experienced a complete stoppage of blood flow throughout your body.
Research Study Groups:
This trial has the following groups:- Group 1: Vasopressin
- Group 2: Phenylephrine
Awards:
This trial has 5 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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