Use of Beta Blockers in Elderly Trauma Patients

NCT00302692 | Unknown Phase 2

• 1 other identifier: AHA 0465044Y
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

Advances in medical care have increased the proportion of elderly Americans and enabled them to remain more physically active. This has resulted in an unprecedented increase in the number of geriatric patients admitted to trauma centers. The elderly constitute 23% of trauma center admissions, but 36% of all trauma deaths. This disproportionately high mortality is attributable to a higher prevalence of pre-existing conditions, particularly, cardiac disease. Multi-system injuries result in critical cardiac stress. Although beta-blockade has been shown to decrease morbidity and mortality in patients at risk for myocardial infarction after elective surgery, their use in trauma patients with potential underlying cardiac disease has not been previously studied. We hypothesize that routine administration of beta-blockers after resuscitation will reduce morbidity and mortality in elderly trauma patients with, or at risk for, underlying cardiac disease. This study is a randomized, prospective clinical trial. One cohort will receive routine trauma intensive care, and the other, the same care plus beta-blockade after completion of resuscitation. The primary outcome will be mortality. Secondary outcomes include MI, length of stay, organ dysfunction, cardiac, and other complications. Changes in outcome may not be due to reduction in myocardial oxygen demand and heart rate. Laboratory studies demonstrate that circulating inflammatory cytokines contribute to cardiac risk in trauma patients, and their production is influenced by adrenergic stimulation. We will measure circulating IL-6, TNF alpha, IL-1beta, and measure NF-kB and p38 MAP kinase activation in peripheral blood leukocytes, and determine the effect of beta-blockade on the production of these inflammatory markers. Finally, the wide variation in patient response to beta-blockers is attributed to genetic variability in the adrenergic receptor. Therefore, we will identify single nucleotide polymorphisms (SNPS) within the beta-adrenergic receptor, and determine their effects on mortality and response to beta-blockade. This study will provide the first randomized, prospective trial designed to reduce morbidity and mortality in elderly trauma patients at risk for cardiac disease. The laboratory and genetic component will provide additional insights that may explain treatment effects, lead to new therapeutic strategies, and have the potential to lead to additional areas of investigation.

Conditions

Multiple Trauma; Cardiovascular Diseases; Aged

Outcome Measures

Primary Outcomes (2)

• Mortality

• Cardiovascular Morbidity

Secondary Outcomes (1)

• Inflammatory Profile

Interventions

Esmolol DRUG

Metoprolol DRUG

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All trauma patients admitted to the ICU \> 55 years of age with a primary diagnosis of injury will be screened on admission as study candidates.

You may not qualify if:

• Patients will be excluded if they have non-survivable injuries, are receiving comfort care only, have an advanced directive limiting aggressive care, heart block, severe asthma, bradycardia (\< 60 bpm), are on beta-blocker therapy, or are having an acute or evolving myocardial infarction.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• American Heart Association: collaborator

Study Sites (1)

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

RECRUITING

Related Publications (1)

• Friese RS, Barber R, McBride D, Bender J, Gentilello LM. Could Beta blockade improve outcome after injury by modulating inflammatory profiles? J Trauma. 2008 Apr;64(4):1061-8. doi: 10.1097/TA.0b013e3181684cf0.

  PMID: 18404076 DERIVED

MeSH Terms

Conditions

Multiple Trauma; Cardiovascular Diseases

Interventions

esmolol; Metoprolol

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Randall Friese, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dara McBride, RN

CONTACT

214 648-7609; mcbride.dara@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2006
• First Posted: March 14, 2006
• Study Start: December 1, 2005
• Study Completion: September 1, 2008
• Last Updated: May 10, 2007

Record last verified: 2007-05

Locations

US (1)