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Phenylephrine for Low Blood Pressure

Phase < 1
Waitlist Available
Led By Noah Jouett, DO/PhD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 to 45 years of age
Be between 18 and 65 years old
Must not have
Subject on anticoagulant treatment
Any known history of renal or hepatic insufficiency/disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up thirty minutes following phenylephrine infusion
Awards & highlights

Summary

This trial is testing phenylephrine, a drug that raises blood pressure, in surgery patients with low blood pressure. The study aims to understand how this drug affects fluid management during surgery.

Who is the study for?
This trial is for adults aged 18-45 with low blood pressure who are not obese, do not smoke, and have no serious mental illnesses or history of heart, vascular, respiratory, neurological/metabolic diseases. Pregnant or breastfeeding individuals and those with renal/hepatic issues or sulfite allergies cannot participate.
What is being tested?
The study tests the effects of Phenylephrine (a vasopressor) versus a saline placebo on Pulse Pressure Variability in simulated hypovolemia during surgery. It aims to inform anesthesiologists on using PPV when patients need drugs to raise blood pressure.
What are the potential side effects?
Phenylephrine may cause side effects like headache, increased heart rate, irregular heartbeat, high blood pressure spikes and possibly anxiety. Reactions can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on blood thinner medication.
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I have a history of kidney or liver problems.
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I have a heart, blood vessel, lung, nerve, or metabolic condition.
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I am allergic to sulfites.
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I have peripheral vascular disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~thirty minutes following phenylephrine infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and thirty minutes following phenylephrine infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pulse Pressure Variability

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PhenylephrineExperimental Treatment1 Intervention
Phenylephrine infusion (0.3 mcg/kg/hr)
Group II: ControlPlacebo Group1 Intervention
Saline infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phenylephrine
2014
Completed Phase 4
~2040

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for intraoperative hypotension, such as phenylephrine, work by causing vasoconstriction through the stimulation of alpha-1 adrenergic receptors in blood vessels. This leads to an increase in blood pressure, which is essential for maintaining adequate organ perfusion and preventing complications during surgery. By quickly restoring blood pressure, these treatments help ensure that tissues receive sufficient oxygen, thereby reducing the risk of organ dysfunction.
Peri-operative hemodynamic therapy: only large clinical trials can resolve our uncertainty.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,076 Previous Clinical Trials
1,056,341 Total Patients Enrolled
Texas Health ResourcesOTHER
15 Previous Clinical Trials
20,201 Total Patients Enrolled
Noah Jouett, DO/PhDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center

Media Library

Phenylephrine Clinical Trial Eligibility Overview. Trial Name: NCT05011357 — Phase < 1
Intraoperative Hypotension Research Study Groups: Phenylephrine, Control
Intraoperative Hypotension Clinical Trial 2023: Phenylephrine Highlights & Side Effects. Trial Name: NCT05011357 — Phase < 1
Phenylephrine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05011357 — Phase < 1
~2 spots leftby Oct 2025