Phenylephrine and Pulse Pressure Variability

NCT05011357 | Completed Early Phase 1 FDA Drug

• 1 other identifier: STU-2021-0497
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intraoperative Hypotension

Keywords

Phenylephrine; Pulse pressure variation

Outcome Measures

Primary Outcomes (1)

• Pulse Pressure Variability

  Quantifying respiratory variation in beat-to-beat arterial blood pressure

  Thirty minutes following phenylephrine infusion

Study Arms (2)

Phenylephrine

EXPERIMENTAL

Phenylephrine infusion (0.3 mcg/kg/hr)

Drug: Phenylephrine

Control

PLACEBO COMPARATOR

Saline infusion

Drug: Saline Control

Interventions

Phenylephrine DRUG

Phenylephrine will be administered as an infusion

Also known as: Phenylephrine infusion

Phenylephrine

Saline Control DRUG

Saline infusion

Also known as: Saline

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Texas Health Resources: collaborator

Study Sites (1)

Texas Health Resources

Dallas, Texas, 75231, United States

Location

MeSH Terms

Interventions

Phenylephrine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Noah Jouett, DO/PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Anesthesiologist

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 18, 2021
• Study Start: September 10, 2021
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)