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Propranolol in Severely Burned Children

Information source: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Burn

Intervention: Propranolol (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: The University of Texas Medical Branch, Galveston

Official(s) and/or principal investigator(s):
David N Herndon, MD, Principal Investigator, Affiliation: University of Texas

Overall contact:
Catherine Reed, RN, Phone: 409-770-6987, Email: ca2reed@utmb.edu

Summary

To determine the safety and efficacy of administration of propranolol for reducing heart rate and blood pressure in burn injury.

Clinical Details

Official title: Safety and Efficacy of Propranolol in Severely Burned Children

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Resting heart rate multiplied by the systolic blood pressure measurement= rate pressure product

Secondary outcome: Number of deaths

Detailed description: Other purposes of this study are to study the effect on muscle function, the infectious process, sepsis, systemic inflammation and long-term scarring. Quality of life will also be looked at over time.

Eligibility

Minimum age: N/A. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Burns covering >20% of the total body surface are

- Age of 0 to 18 years

- Patient arrival to the burn center within 96 hours (4 days) of burn injury

- Require > 1 surgical procedure

Exclusion Criteria:

- Pregnancy

- Known history of AIDS, ARC, or HIV

- History of cancer within 5 years

- Existence of pre-morbid conditions

- Asthma

- Congestive heart failure (measured ejection fraction < 20%)

- Medical condition requiring glucocorticoid treatment

- Burn injury due to chemical burns

- Burn injury due to deep electrical injury (decision of hospital PI)

- Presence of anoxic brain injury that is not expected to result in complete

recovery

- Decision not to treat due to burn injury severity

Locations and Contacts

Catherine Reed, RN, Phone: 409-770-6987, Email: ca2reed@utmb.edu

Shriners Hospitals for Children, Sacramento, California 95817, United States; Not yet recruiting
David Greenhalgh, MD, Email: DGHalgh@shrinenet.org
David Greenhalgh, MD, Principal Investigator

Shriners Hospitals for Children, Boston, Massachusetts 02114, United States; Not yet recruiting
Robert Sheridan, MD, Email: rsheridan@partners.org
Robert Sheridan, MD, Principal Investigator

Shriners Hospitals for Children, Cincinnati, Ohio 45229, United States; Not yet recruiting
Richard Kagan, MD, Email: rkagan@shrinenet.org
Richard Kagan, MD, Principal Investigator

Shriners Hospitals for Children, Galveston, Texas 77551, United States; Recruiting
Cathy Reed, BSN, Phone: 409-770-6987, Email: ca2reed@utmb.edu
Deb Benjamin, MSN, Phone: 409-770-6731, Email: dbenjami@utmb.edu
David N Herndon, MD, Principal Investigator

Additional Information

Starting date: December 2013
Last updated: June 11, 2015

Page last updated: August 23, 2015

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