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Phenylephrine and Pulse Pressure Variability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05011357
Recruitment Status : Recruiting
First Posted : August 18, 2021
Last Update Posted : February 17, 2023
Sponsor:
Collaborator:
Texas Health Resources
Information provided by (Responsible Party):
Noah Jouett, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE August 11, 2021
First Posted Date  ICMJE August 18, 2021
Last Update Posted Date February 17, 2023
Actual Study Start Date  ICMJE September 10, 2021
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2021)		 Pulse Pressure Variability [ Time Frame: Thirty minutes following phenylephrine infusion ]
Quantifying respiratory variation in beat-to-beat arterial blood pressure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phenylephrine and Pulse Pressure Variability
Official Title  ICMJE Effect of Phenylephrine Infusion on Pulse Pressure Variability
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.
Detailed Description

Perioperative fluid administration is a very important issue in modern anesthesia practice. Overzealous intraoperative administration of fluids can lead to cardiac overload thus potentially causing significant morbidity. It has been demonstrated that over 50% of perioperative complications are tied to intraoperative fluid administration and that changing intraoperative fluid management alone has significant positive benefit. Pulse pressure variation (PPV), which quantifies the respiratory variation in beat-to-beat arterial blood pressure, is viewed as a reliable method to assess volume status. Increasing PPV indicates hypovolemia, and a decreasing PPV indicates progression towards euvolemia. However, there are many commonly encountered intraoperative conditions that may make these interpretations of PPV problematic. For example it is commonly accepted in the perioperative community that PPV is interpretable in patients without vasopressor infusion since there is little consensus to the effects of vasopressor therapy on PPV. Hence the proposed study seeks to characterize the PPV response during simulated hypovolemia with and without infusion of phenylephrine, which acts on alpha-1 receptors to increase systemic vascular resistance, and hence blood pressure.

In a patient under general anesthesia, a PPV cut-off of 13% indicates a positive response to fluid administration. However, this cut-off was based on studies that used a wide variety of vasopressor agents with different mechanisms. Furthermore, it is unclear how effective the current threshold is at predicting fluid responsiveness when vasopressors are added during the same operation (i.e. a PPV of 13% without vasopressors likely represents different physiologic conditions compared to a PPV of 13% with vasopressors in the same operation). Hence, understanding how vasopressors such as phenylephrine change PPV and the PPV threshold is very important and represents an important knowledge gap in the practice of anesthesia.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description:
Single blind
Primary Purpose: Basic Science
Condition  ICMJE Intraoperative Hypotension
Intervention  ICMJE
  • Drug: Phenylephrine
    Phenylephrine will be administered as an infusion
    Other Name: Phenylephrine infusion
  • Drug: Saline Control
    Saline infusion
    Other Name: Saline
Study Arms  ICMJE
  • Experimental: Phenylephrine
    Phenylephrine infusion (0.3 mcg/kg/hr)
    Intervention: Drug: Phenylephrine
  • Placebo Comparator: Control
    Saline infusion
    Intervention: Drug: Saline Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 11, 2021)		 6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2024
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Noah P Jouett, DO/PhD (214) 648-5460 noah.jouett@utsouthwestern.edu
Contact: David McDonagh, MD 214/648-8083 david.mcdonagh@utsouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05011357
Other Study ID Numbers  ICMJE STU-2021-0497
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Noah Jouett, University of Texas Southwestern Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Texas Health Resources
Investigators  ICMJE
Principal Investigator: Noah Jouett, DO/PhD University of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP