TraumaPhase 2NCT00356187

Beta Blockade in Critical Injury

A Phase 2 study testing Propranolol in people with Trauma, run by Denver Health and Hospital Authority at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Trauma
What is being tested?: Propranolol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 15 Feb 2006to 31 Jan 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Denver Health Medical Center
Denver, Colorado, 80204

Other trials in United States

About this study

Official title: Beta-blockade Reduces Catabolism in Severely Injured Trauma Patients

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.

Conditions: Trauma
Being tested: Propranolol
Medical subject headings: Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PropranololDrug

Study groups in NCT00356187
Study group	Role	What they receive
Propranol Treatment	Experimental	Not described Receives: Drug: Propranolol
Standard of Care	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in REE vs. Controls
Measured: ICU admission date to ICU discharge or death

Secondary outcomes (3)

Changes in Protein Metabolism Measurements
net nitrogen balance, fat-free mass, and fat mass
Measured: ICU admission date to ICU discharge or death
Alterations in Neuroendocrine and Immunoinflammatory Measurements
blood glucose levels, insulin requirements, cortisol levels, IL-6 and IL-10 levels, infection rates, and organ dysfunction
Measured: ICU admission date to ICU discharge or death
Clinical Outcome Measurements
Ventilator days, ICU and hospital days, and in-hospital mortality
Measured: ICU admission date to ICU discharge or death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 200631 Jan 2009

First posted25 Jul 2006 (estimated)
Study start15 Feb 2006
Primary completion31 Jan 2009
Study completion31 Jan 2009

Why it stopped: Slow enrollment, end of funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for TraumaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00356187
Sponsor's protocol ID: R03 DK73349 (completed)
Other IDs: R03DK073349
Status last verified: Feb 2018
First submitted: 24 Jul 2006
Last updated: 15 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Trauma trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Beta-blockade Reduces Catabolism in Severely Injured Trauma Patients
ClinicalTrials.gov ID: NCT00356187
Acronym / sponsor ID: R03 DK73349 (completed)
Conditions: Trauma
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow enrollment, end of funding
Enrolment: 15 participants (actual)
Lead sponsor: Denver Health and Hospital AuthorityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 15 Feb 2006 (actual)
Primary completion: 31 Jan 2009 (actual)
Study completion: 31 Jan 2009 (actual)
First posted: 25 Jul 2006 (estimated)
Results: Posted 7 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Propranol Treatment	Experimental	Drug: Propranolol
Standard of Care	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Propranolol	Drug	Propranol Treatment

Primary outcome

Change in REE vs. Controls
Time frame: ICU admission date to ICU discharge or death

3 secondary outcomes

Changes in Protein Metabolism Measurements
Time frame: ICU admission date to ICU discharge or death
Alterations in Neuroendocrine and Immunoinflammatory Measurements
Time frame: ICU admission date to ICU discharge or death
Clinical Outcome Measurements
Time frame: ICU admission date to ICU discharge or death

Results and safety

Results posted to the registry on 7 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Propranol Treatment	0	0
Standard of Care	0	0

Primary outcome: Change in REE vs. Controls

Time frame: ICU admission date to ICU discharge or death

Population analysed: Insufficient enrollment to derive any results. Study closed in 2009 and is past data retention. PI has left institution and does not have any access to any data.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Propranol Treatment	0 of 0	0 of 0	Not reported
Standard of Care	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Trauma

Not yet recruitingObservational study
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RecruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Propranolol in people with Trauma, run by Denver Health and Hospital Authority at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in REE vs. Controls (time frame: ICU admission date to ICU discharge or death). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00356187.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.