Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000550909
Ethics application status
Approved
Date submitted
25/05/2011
Date registered
31/05/2011
Date last updated
6/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Adrenergic blockade in adult burns patients
Scientific title
The effect of adrenergic blockade on hypermetabolism in patients post burn injury
Secondary ID [1] 262159 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn injury greater than 30% body surface area 265844 0
Condition category
Condition code
Injuries and Accidents 265998 265998 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The medication propranolol hydrochloride for 30 days with 1mg/kg/day in four divided doses titrated upwards to decrease resting heart rate by 20%
Intervention code [1] 264571 0
Treatment: Drugs
Comparator / control treatment
The control group will be given no extra medication. Standard care only including appropriate fluid resuscitation, early debridement and split skin grafting, optimal nutrition, infection surveillance, compression garments, exercise and splinting will be provided. There will be no placebo.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266746 0
Body composition (% fat and lean soft tissue mass) will be estimated with dual energy X-ray absorptometry (DXA, Lunar Prodigy Advance, Madison, WI, USA). Results will be expressed as a % of predicted matched in reference populations.
Timepoint [1] 266746 0
Baseline, four weeks and three months.
Secondary outcome [1] 276297 0
Cardiac function- Echocardiography - cardiac output, ejection fraction and wall thickness will be measured
Timepoint [1] 276297 0
Baseline and four weeks
Secondary outcome [2] 276298 0
Physical work capacity - tested by the modified shuttle walk test. This is an externally-paced, incremental, symptom-limited maximal test .
Timepoint [2] 276298 0
Four weeks and three months from enrolment
Secondary outcome [3] 276299 0
Resting energy expenditure via metalyzer MetaMax 3B analyser (Cortex:biophysik, GMbH, Germany) actual % REE will be compared with predicted % REE for BMI and age after an overnight fast, resting conditions and controlled ambient temperature 270C, based on the Respiratory quotient based equation.
Timepoint [3] 276299 0
Enrolment (baseline), and every week until discharge from hospital then once at the final three month point
Secondary outcome [4] 276300 0
Insulin sensitivity, glucose and fat metabolism - Eleven mls of blood will be taken after an overnight fast and at least 24 hours since any exercise. Plasma glucose and lipids measured by Beckman DXC
Serum cortisol, plasma insulin will be measured using Beckman DXI. Insulin resistance will be measured by the reciprocal index of homoeostasis model assessment (HOMA-IR)21.
Timepoint [4] 276300 0
Baseline, four weeks and three months
Secondary outcome [5] 276301 0
Plasma adrenaline & noradrenaline - Ten mls of venous blood collected into precooled lithium heparin tubes with antioxidant (0.1mL sodium metabisulphite)- will be analysed by HPLC with electrochemical detection.
Timepoint [5] 276301 0
Baseline, four weeks and three months
Secondary outcome [6] 276302 0
Wound healing - The time to donor site wound healing and to 10% residual burn wound (of original burn size) remaining unhealed, compared between groups. Wound healing will be judged by experienced burn health care practitioners
Timepoint [6] 276302 0
Baseline and every week until three months
Secondary outcome [7] 276303 0
Analysis of gait (walking) using 3-dimensional Vicon motion analysis system, EMG and force plates to quantify gait analysis
Timepoint [7] 276303 0
Three months post enrolment

Eligibility
Key inclusion criteria
Acute burns patients
18years of age and over
30% total burns surface area,
Ready for discharge from intensive care, at a stage when they do not require inotropic support, are non septic, antibiotic free and capable of spontaneous breathing on a high flow humidifier
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Concomitant multi-trauma,
Pregnancy,
Lactation,
A premorbid history of asthma or bronchospasm,
Peripheral arterial disease,
Diabetes,
Systolic blood pressure<100mmHg or mean arterial pressure of < 65mmHg,
Heart rate<60bpm,
Heart block on ECG,
Previous use of beta blockers before the burn injury, or previous prescription for greater than 24 hours within the preceding 24 hours,
Allergic disorders
Any cardiovascular conditions (hypertension, coronary artery disease, left ventricular systolic impairment, pulmonary hypertension, right ventricular impairment, sick sinus syndrome, heart block),
Renal or hepatic impairment,
Hyperthyroidism,
Previous depressive illness
Compassionate care only

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients will be identified and consent will be sought by the chief and principal investigators, with next of kin or substitute decision maker. The randomization sequence will be generated and re-identifiable serial numbers will be assigned by a research personnel not involved in the study. They will be concealed from consent designee research staff for group allocation to prevent selection bias and protected by an electronic password.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants recruited will be randomized into control and intervention arms using computer generated randomization; http://www.randomization.com/ with stratification of females
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 265071 0
Charities/Societies/Foundations
Name [1] 265071 0
Royal Brisbane & Womens Hospital Research Foundation
Country [1] 265071 0
Australia
Primary sponsor type
University
Name
Burns, Trauma & Critical Care Research Centre
Address
Dept of Intensive Care Medicine,
Level 3, NHB,
Royal Brisbane & Womens Hospital
Butterfield St,
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 264209 0
Hospital
Name [1] 264209 0
Royal Brisbane & Womens Hospital
Address [1] 264209 0
Dept of Intensive Care Medicine,
Level 3, NHB,
Royal Brisbane & Womens Hospital
Butterfield St,
Herston QLD 4029
Country [1] 264209 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267051 0
Royal Brisbane & Womens Hospital HREC
Ethics committee address [1] 267051 0
Floor 7, Block 7
Royal Brisbane & Womens Hospitral,
Butterfield St, Herston 4029 QLD
Ethics committee country [1] 267051 0
Australia
Date submitted for ethics approval [1] 267051 0
22/03/2011
Approval date [1] 267051 0
28/04/2011
Ethics approval number [1] 267051 0
HREC/11QRBW/128

Summary
Brief summary
Post burn injury, survivors undergo a “hypermetabolic” response resulting in loss of muscle mass and increase in fat tissue, increased cardiac work, and delays in wound healing. Consequently these patients have weakness, increased length of hospital stay decreased functional ability and delayed return to work rates.
One way to counteract this problem is by pharmacological blockade ie using medication to block the hypermetabolic response. One drug that has been trialled extensively in paediatrics are beta - blockers which decrease the work of the heart. The studies in children have shown these drugs can improve donor site and graft healing, attenuate muscle mass loss, prevent loss of lean muscle mass, improve immune function and decrease in the high temperature, high heart rate, increased cardiac work, and fatty infiltration of the liver. There have been two small trials in adults who did not blind investigators, investigate long term factors and included patients with burns less than 30% total body surface area.
We plan to complete a single blinded, randomized trial on beta -adrenergic blockade in large severe adult burns patients investigating a number of important long term outcomes including lean muscle mass, cardiac function, wound healing, exercise capacity and metabolic profile.
The specific aim is to investigate whether Propranolol)1mg/kg/day) a nonselective beta(1,) beta(2)-receptor antagonist, can prevent the loss of lean muscle mass and improve cardiac function, wound healing, exercise capacity and metabolic profile following severe thermal injury
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32602 0
Address 32602 0
Country 32602 0
Phone 32602 0
Fax 32602 0
Email 32602 0
Contact person for public queries
Name 15849 0
Dr Jason Roberts
Address 15849 0
Dept Intensive Care Medicine,
Level 3, NHB,
Royal Brisbane & Womens Hospital,
Butterfield St,
Herston, Queensland 4029
Country 15849 0
Australia
Phone 15849 0
61 7 36364108
Fax 15849 0
61 7 36363542
Email 15849 0
j.roberts2@uq.edu.au
Contact person for scientific queries
Name 6777 0
Dr Jennifer Paratz
Address 6777 0
Dept Intensive Care Medicine,
Level 3, NHB,
Royal Brisbane & Womens Hospital,
Butterfield St,
Herston, Queensland 4029
Country 6777 0
Australia
Phone 6777 0
61 7 36361980
Fax 6777 0
61 7 36363542
Email 6777 0
j.paratz@uq.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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