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Vasoconstrictor

Angiotensin II for Low Blood Pressure During Surgery

Phase 1
Recruiting
Led By Rohesh Fernando, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing general anesthesia
Diagnosis of hypertension and treatment with at least one medication including an ACE inhibitor, ARB, and other agents for greater than 2 months
Must not have
Chronic obstructive pulmonary disease
History of myocardial infarction or cardiac stents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 hour
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether giving angiotensin II intravenously can help with low blood pressure during anesthesia in adults, which is common and can cause problems.

Who is the study for?
This trial is for adults with high blood pressure who are undergoing general anesthesia and have been treated with blood pressure medications, including ACE inhibitors or ARBs, for over two months. It's not suitable for individuals with asthma, severe obesity (BMI > 40), pregnant women, those with a history of serious heart or lung conditions, stroke, deep vein thrombosis or difficult airways.
What is being tested?
The study is testing the effectiveness of intravenous Angiotensin II as a treatment for low blood pressure that occurs during general anesthesia in patients who already have high blood pressure and are on certain medications.
What are the potential side effects?
Potential side effects may include reactions at the injection site, changes in heart rate or rhythm, allergic reactions to the drug components, kidney function alterations and possible increases in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will be put to sleep for surgery.
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I have been treated for high blood pressure with medication for over 2 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have chronic obstructive pulmonary disease.
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I have had a heart attack or have cardiac stents.
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I have been diagnosed with congestive heart failure.
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I have had deep vein thrombosis or blood clots before.
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I have had a stroke in the past.
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I have asthma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 hour
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 hour for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean dose required to increase the SBP
Secondary study objectives
Mean value of Aldosterone
Mean value of Angiontensin
Mean value of Bradykinin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Participants on ARBsExperimental Treatment1 Intervention
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Group II: Participants on ACE inhibitorsExperimental Treatment1 Intervention
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Group III: Other Classes of Antihypertensive AgentsExperimental Treatment1 Intervention
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Angiotensin II
2010
Completed Phase 4
~260

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,392 Previous Clinical Trials
2,452,802 Total Patients Enrolled
Rohesh Fernando, MDPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Angiotensin II (Vasoconstrictor) Clinical Trial Eligibility Overview. Trial Name: NCT03733145 — Phase 1
High Blood Pressure Research Study Groups: Participants on ACE inhibitors, Participants on ARBs, Other Classes of Antihypertensive Agents
High Blood Pressure Clinical Trial 2023: Angiotensin II Highlights & Side Effects. Trial Name: NCT03733145 — Phase 1
Angiotensin II (Vasoconstrictor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03733145 — Phase 1
~17 spots leftby Dec 2026
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