Recruiting
Phase 1

Phenylephrine

Sponsor:

University of Manitoba

Code:

NCT01731444

Conditions

Blood Loss, Surgical

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Phenylephrine

Study Details

Brief summary:

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.

Conditions

Blood Loss, Surgical

Study ID

NCT01731444

Start date

Dec 1, 2014

Status verified date

May, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phenylephrine

20 ug/cc

active comparator: Epinephrine

1:1000000

Interventions

Phenylephrine

Primary outcome measure

  • Mean arterial blood pressure (MAP) [ Time Frame: during first 30 minutes ]

Central Contacts and Locations

Central contacts

Justin Gawaziuk, MSc

2047873669jgawaziuk@hsc.mb.ca

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3A 1R9

Contacts

Justin P Gawaziuk, MSc

2047873669jgawaziuk@hsc.mb.ca

Principal Investigator:

Sarvesh Logsetty, MD

More Information

Sponsor

University of Manitoba

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • blood loss
  • burn
  • hemostasis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2026-05-14.