Beta Blockade in Critical Injury

NCT ID: NCT00356187

Last Updated: 2018-03-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-15

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propranol Treatment

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Propranolol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Denver Health and Hospital Authority

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Denver Health Medical Center

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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R03DK073349

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R03 DK73349 (completed)

Identifier Type: -

Identifier Source: org_study_id

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