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Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01731444
First received: November 15, 2012
Last updated: November 30, 2015
Last verified: November 2015
  Purpose

The standard of care for treatment of burn injury is to inject a solution of epinephrine under the skin of the injured site in order to reduce blood loss during skin grafting. This solution of epinephrine has been shown to have effects on the body outside the donor site. Some people have increases in heart rate and blood pressure. We will study the effect of a phenylephrine solution in place of an epinephrine solution to control blood loss. We think that phenylephrine will help decrease blood loss and not change blood pressure or heart rate.

The injured area will be injected under the skin and a skin graft will be taken in the same way as we usually do. The only change will be the use of phenylephrine in the solution instead of epinephrine.

Our goal is to find whether or not phenylephrine or epinephrine solution results in a reduction of blood loss without affecting the rest of the body.


Condition Intervention Phase
Blood Loss, Surgical
Drug: Phenylephrine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury - A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Mean arterial blood pressure (MAP) [ Time Frame: during first 30 minutes ] [ Designated as safety issue: Yes ]
    Mean arterial blood pressure


Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: q15 min ] [ Designated as safety issue: Yes ]

    Cut off for safety: Diastolic >140 or Systolic >180;

    Recorded:

    • just prior to induction of anesthesia
    • maximum heart rate during time of procedure
    • minimum heart rate during time of procedure

  • Heart Rate [ Time Frame: q15 min ] [ Designated as safety issue: Yes ]

    Recorded:

    • just prior to induction of anesthesia
    • maximum heart rate during time of procedure
    • minimum heart rate during time of procedure


Estimated Enrollment: 24
Study Start Date: December 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phenylephrine
20 ug/cc
Drug: Phenylephrine
Active Comparator: Epinephrine
1:1000000
Drug: Phenylephrine

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

a) Burn injury requiring debridement and grafting between 5-30% TBSA

Exclusion Criteria

  1. Head and neck, hand, foot, or genital burns
  2. On anticoagulants (except NSAIDs)
  3. On monoamine oxidase inhibitor or tricyclic antidepressant
  4. Coronary or peripheral vascular disease
  5. History of arrhythmias
  6. On a Beta-blocker
  7. History of vascular abnormality
  8. Hypertension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731444

Contacts
Contact: Justin Gawaziuk, MSc 2047873669 jgawaziuk@hsc.mb.ca

Locations
Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Justin P Gawaziuk, MSc    2047873669    jgawaziuk@hsc.mb.ca   
Principal Investigator: Sarvesh Logsetty, MD         
Sponsors and Collaborators
University of Manitoba
  More Information

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01731444     History of Changes
Other Study ID Numbers: PhenylephrineRCT 
Study First Received: November 15, 2012
Last Updated: November 30, 2015
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
blood loss
burn
hemostasis

Additional relevant MeSH terms:
Hemorrhage
Burns
Blood Loss, Surgical
Pathologic Processes
Wounds and Injuries
Intraoperative Complications
Phenylephrine
Oxymetazoline
Hemostatics
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Coagulants

ClinicalTrials.gov processed this record on September 23, 2016