Beta Blockade in Critical Injury

This study has been completed.

First Received on July 24, 2006. Last Updated on March 17, 2010 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00356187

Purpose

Critically injured patients endure a period of hypermetabolism/catabolism after being resuscitated. The metabolic cost of this may be measured in loss of lean body mass, poor wound healing, susceptibility to infection and long hospital stays. While there have been some data to suggest that hypermetabolism can be ameliorated in burn patients by beta blockade, to our knowledge, a prospective trial in trauma patients has not yet been done. Our hypothesis is that nonselective beta blockade will reduce catabolism, improve glucose control, blunt loss of lean body mass, decrease infections and improve outcome in a cohort of critically injured patients.

Condition	Intervention
Trauma	Drug: Propranolol

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Beta-blockade Reduces Catabolism in Severely Injured Trauma Patients

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds

Drug Information available for: Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Lean body mass
ICU length of stay
Infectious complications

Secondary Outcome Measures:

Metabolic rate
Glucose control
Nitrogen Balance

Estimated Enrollment:

100

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ISS>25, stable at 48 hours after injury
Fully resuscitated
Ventilated

Exclusion Criteria Include:

Intracranial hypertension requiring active treatment
Hypotension/Pressors
Already on beta blocker for a standard indication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356187

Locations

United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00356187 History of Changes
Other Study ID Numbers:	R03 DK73349 (completed)
Study First Received:	July 24, 2006
Last Updated:	March 17, 2010
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Wounds and Injuries
Propranolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents

Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents

ClinicalTrials.gov processed this record on February 09, 2012