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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 hour
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I will be put to sleep for surgery.
Select...
I have been treated for high blood pressure with medication for over 2 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 hour
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean dose required to increase the SBP
Secondary outcome measures
Mean value of Aldosterone
Mean value of Angiontensin
Mean value of Bradykinin
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
1,241 Previous Clinical Trials
1,004,177 Total Patients Enrolled
Rohesh Fernando, MDPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have chronic obstructive pulmonary disease.I have had a heart attack or have cardiac stents.You have a hard time breathing.I will be put to sleep for surgery.You have a body mass index (BMI) higher than 40.I have been diagnosed with congestive heart failure.I have been treated for high blood pressure with medication for over 2 months.I have had deep vein thrombosis or blood clots before.Your baseline blood pressure is 160 mmHg or higher.I have had a stroke in the past.I have asthma.
Research Study Groups:
This trial has the following groups:- Group 1: Participants on ACE inhibitors
- Group 2: Participants on ARBs
- Group 3: Other Classes of Antihypertensive Agents
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there any remaining opportunities for participants in this research?
"Affirmative. According to clinicaltrials.gov, the trial which was first announced on October 3rd 2019 is actively recruiting patients and has recently been updated on May 31st 2022. Currently, 60 participants need to be enrolled from a single medical site."
Answered by AI
How many participants are currently recruited for this experiment?
"Affirmative. The information available on clinicaltrials.gov indicates that this trial is actively seeking qualified study participants, with the initial posting dated October 3rd 2019 and last update occurring on May 31st 2022. This research project requires 60 patients to be recruited from 1 site."
Answered by AI
What potential harm could be posed to patients by exposure to Angiotensin II?
"As this is a Phase 1 trial, the safety of Angiotensin II was rated on our scale as a conservative 1 due to its lack of substantial evidence concerning efficacy and protection."
Answered by AI
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