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Vasopressor
Norepinephrine vs Vasopressin for Heart Surgery Patients
Phase 3
Waitlist Available
Led By Mariya Geube, MD
Research Sponsored by The Cleveland Clinic
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 during surgery
Awards & highlights
Study Summary
This trial found that, for patients requiring vasopressor support during cardiac surgery, those with increased pulmonary artery pressure had a greater relative increase in mPAP with the same unit increase in MAP, as compared to those with normal pulmonary artery pressure. RV function was assessed by GLS.
Who is the study for?
This trial is for adults over 18 who are having elective heart surgery with a device called CPB and need a pulmonary artery catheter. They must have low blood pressure during surgery needing drugs to raise it. It's not for those getting transplants, certain implants, specific lung surgeries, or using inhaled lung medicines before the study starts.Check my eligibility
What is being tested?
The study looks at how two drugs, Norepinephrine (NE) and Vasopressin (VP), affect blood pressure in the lungs compared to overall blood pressure during heart surgery. It also checks how these drugs influence right ventricle function when patients need vasopressor support.See study design
What are the potential side effects?
Possible side effects of NE and VP include changes in heartbeat rhythm, headaches, feelings of anxiety or restlessness; they can also potentially affect water balance or cause chest pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
mPAP-to-MAP ratio between patients who received norepinephrine versus vasopressin intraoperatively.
Trial Design
2Treatment groups
Active Control
Group I: The use of norepinephrine compared with vasopressinActive Control1 Intervention
The investigators will compare GLS between patients who received norepinephrine versus vasopressin intraoperatively.
Group II: The use of vasopressin compared with norepinephrineActive Control1 Intervention
The investigator hypothesize that the use of vasopressin compared with norepinephrine induces a lower mPAP-to-MAP ratio, in cardiac surgical patients with and without pulmonary hypertension who require intraoperative vasopressor support.
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Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,365,916 Total Patients Enrolled
Mariya Geube, MDPrincipal InvestigatorThe Cleveland Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am getting a heart pump implant that is not an intra-aortic balloon.I am scheduled for or have had a surgery to remove blood clots from my lungs.I need medication through an IV to maintain my blood pressure.I am scheduled for heart surgery that will use a heart-lung machine.I am scheduled for surgery to repair an aneurysm in my chest and abdomen.Vasopressin was the first choice of treatment for my low blood pressure.I am over 18 years old.I am scheduled for a transplant surgery.I have had a catheter inserted into my pulmonary artery.I received a medication to widen my lung blood vessels before a heart catheter test.
Research Study Groups:
This trial has the following groups:- Group 1: The use of norepinephrine compared with vasopressin
- Group 2: The use of vasopressin compared with norepinephrine
Awards:
This trial has 4 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What does norepinephrine do that is different than vasopressin when treating patients?
"Norepinephrine, which is often used in place of vasopressin to treat catecholamines, can also be used to address hypotension, during anesthesia, and in cases of shock."
Answered by AI
How many total volunteers are needed for this experiment?
"That is correct. The information on clinicaltrials.gov does show that the study is looking for 150 people to participate across 1 location. The study was posted on 11/5/2020 and was most recently updated on 10/12/2021."
Answered by AI
What is the difference between norepinephrine and vasopressin in terms of FDA approval?
"Norepinephrine's safety relative to vasopressin has been well studied in multiple Phase 3 clinical trials, so it received a score of 3."
Answered by AI
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