Phenylephrine and Pulse Pressure Variability (NCT05011357) | Clinical Trial Compass
CompletedEarly Phase 1
Phenylephrine and Pulse Pressure Variability
United States8 participantsStarted 2021-09-10
Plain-language summary
The purpose of this research study is to determine how vasopressors affect a measure of how intravenous fluid is administered in people undergoing surgery who have low blood pressure called Pulse Pressure Variability (PPV). This study will recruit human subjects to undergo simulated hypovolemia called Lower Body Negative Pressure (LBNP) and will receive phenylephrine and placebo, while PPV will be measured in both conditions. This research will help anesthesiologists learn more about how to use PPV in patients undergoing surgery and who need vasopressors.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 to 45 years of age
* Non-obese (Body Mass Index less than 30 kg/m2)
* Baseline systolic blood pressure between 80-140 mmHg
* Baseline diastolic blood pressure \<90 mmHg
Exclusion Criteria:
* Participants who have cardiac, vascular, respiratory, neurological and/or metabolic illness
* Current or previous use of anti-hypertensive medications
* Any known history of renal or hepatic insufficiency/disease
* Pregnancy (verified by negative urine test on the experimental days) or breast-feeding
* Current smokers, as well as individuals who regularly smoked within the past 3 years
* Sulfite allergy, as this is a contraindication to intravenous phenylephrine
* Serious mental illness including claustrophobia
* History of use of recreational drugs including cocaine or amphetamines
* Peripheral vascular disease
* Subject on anticoagulant treatment
* Subjects with a baseline systolic blood pressure \<80 mmHg
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pulse Pressure Variability
Timeframe: Thirty minutes following phenylephrine infusion
Trial details
NCT IDNCT05011357
SponsorUniversity of Texas Southwestern Medical Center