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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 belowSelect...
I am between 18 and 45 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently on blood thinner medication.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ thirty minutes following phenylephrine infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~thirty minutes following phenylephrine infusion
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.
Peri-operative hemodynamic therapy: only large clinical trials can resolve our uncertainty.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently smoking or have smoked regularly in the past 3 years.I am currently on blood thinner medication.I am currently using or have used blood pressure medication.I have a history of kidney or liver problems.I have a heart, blood vessel, lung, nerve, or metabolic condition.You are not overweight (your body mass index is less than 30).I am allergic to sulfites.I am between 18 and 45 years old.Your resting diastolic blood pressure is less than 90 mmHg.Your blood pressure is too low before starting the study.Your blood pressure should be between 80 and 140 mmHg before starting the trial.You have used recreational drugs like cocaine or amphetamines in the past.You have a serious mental illness, like claustrophobia.I have peripheral vascular disease.
Research Study Groups:
This trial has the following groups:- Group 1: Phenylephrine
- Group 2: Control
Awards:
This trial has 0 awards, including: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.
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