ArrestNCT05805553
Anabolic Steroid and Propranolol in Paediatric Burn
A study testing Propranolol and Nandrolone Decanoate in people with Arrest and Bone, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
propranolol and anabolic steroids have a role in pediatric burn patients and their combined effects are to be studied here. They decrease the catabolic response to burn trauma and minimize the duration of growth arrest hence improving the outcome Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Arrest, Bone, Development
- What is being tested?
- Propranolol and Nandrolone Decanoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2020to 28 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients presenting within 48 hours of burn
- more than 20% and less than 40 %of TBSA burn (measured via modified rule of nine for pediatric burn according to age)
- age 2-12 years (as safety of anabolic steroids is not established in <2years of age)
- Scald and flame burn
Who cannot join
- Diabetics (diagnosed before hospital admission)
- Renal disease (diagnosed before hospital admission)
- Asthmatics (on medication previously)
- Cardiac anomalies (previously diagnosed)
- Patients requiring cardiac support (norepinephrine, dobutamine at any dose and dopamine >7ug/kg).
- All 4 limbs burnt
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
King Edward Medical University, Mayo Hospital
Lahore, Punjab Province, 54000
Azwa Janjua, 03326223344, azwamunim@gmail.com
About this study
Official title: Role of Anabolic Steroid and Propranolol in Paediatric Burn- A Randomized Controlled Trial
propranolol and anabolic steroids have a role in pediatric burn patients and their combined effects are to be studied here. They decrease the catabolic response to burn trauma and minimize the duration of growth arrest hence improving the outcome
Read the detailed description
Burn is a major cause of morbidity and mortality worldwide; rate being seven times higher in low- and middle- income countries than high income countries. According to WHO, worldwide 11million people require medical attention secondary to burns. In Pakistan, 17% of burn patients have temporary disability while 18% suffer from a permanent disability Various studies have been done to improve patient outcome in terms of morbidity and mortality. Different medical interventions seem to have promising role in improving patient outcome in burn population.
Majority of pathological problems are due to catecholamines, an integral part of systemic metabolic drive, which increase approximately 10-fold as a response to injury . Hypermetabolic state has two aspects-the "ebb" and "flow" phases. The "ebb" phase lasts till first 48hours and has decreased metabolic rate and oxygen consumption while "flow" phase, which starts after resuscitation and has huge metabolic turnover, is the problematic one and needs intervention to decrease grave outcomes on patient's health. Systemic effects of catecholamines are significant once burned surface area increases more than 20% of the TBSA and persist for years . Various studies show that Propranolol and Oxandrolone have beneficial effects on decreasing morbidity and mortality in burn population Propranolol, a non-selective beta adrenergic blocker, has been used to minimize systemic effects of catecholamines and hypothetically results in anti-catabolic effects especially when given during ebb phase of the process i.e. decreases heart rate (HR) and blood pressure (BP) while during flow phase it increases hematocrit levels by increasing the renal erythropoietin secretion and decreases number of transfusions as well as blood loss during skin grafting "Herndon et al demonstrated that the cardiac effort was significantly reduced by 20% to 36% when the patients were given 2 mg/kg every 24 hours for 5 days. They determined that an ideal dose of 0.5 to 1.0 mg/kg intravenously every 6 to 8 hours should be given to adequately reduce left ventricular work without adversely affecting oxygen delivery or other cardiac functions" In another study done by Minifee et al, propranolol does not affect overall body delivery and consumption of oxygen but significantly decreases cardiac muscle requirement of oxygen . Moreover hyper-/hypo-glycemia, hypotension, azotemia, hypothermia, arrythmias and peripheral ischemia are also not observed as adverse effects . Another study by Baron et al showed that prolonged administration of oral or IV propranolol does not have an adverse effect on morbidity or mortality
Anabolic steroid (Oxandrolone/nandrolone) has a definite role in building up body's protein stores. Unlike testosterone, its adverse effects, acne, hirsutism, behavioral changes and liver functions are not documented, so they are considered safe. Use of oxandrolone alone and in combination with propranolol has a definitive effect as anti-catabolic agent and helps in better recovery and long-term outcomes on child's growth and decreases cardiac load.
A study done by Sylvia Ojeda et al at university of Texan in 2018 showed that propranolol is both safe and effective in managing the cardiovascular effects of hypermetabolic state in burn patients. A couple of other studies show that both propranolol and oxandrolone have a role in reducing the burden of disease in burn but data is lacking on effects of administration of both the drugs combined. Moreover, how the medication will affect our population is yet to be determined. This study will help us compare the effects of both drugs in our population and decrease the morbidity and mortality in burn patients.
- Conditions
- Arrest, Bone, Development, Growth
- Being tested
- Propranolol, Nandrolone Decanoate
- Keywords
- Pediatric, Burn, Propranolol, Steroid, Growth, arrest
- Medical subject headings
- Heart Arrest, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
2mg/kg/day in 3-4 dividd doses
Nandrolone DecanoateDrug
1mg/kg weekly
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Propranolol will be given to this group Receives: Drug: Propranolol |
| group b | Experimental | steroid will be given Receives: Drug: Nandrolone Decanoate |
| group c | Experimental | both propranolol and steroids will be given Receives: Drug: Propranolol; Drug: Nandrolone Decanoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
reversal of growth arrest
BMI in kg/m^2
Measured: at 1 year after burn
Bone mineral density measure
Bone mineral density as g/cm^2 (Z-score)
Measured: at 1 year
Secondary outcomes (1)
no of blood transfusions
number of blood transfusions during hospital stay
Measured: at 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Dec 2020
- Primary completion28 Sep 2023 (estimated)
- Study completion28 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrestStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Three groups are made. one will receive steroid (control group). other will receive propranolol and third will receive both propranolol and steroid. their results will be compared
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805553
- Sponsor's protocol ID
- 126/RC/KEMU
- Status last verified
- Mar 2023
- First submitted
- 26 Jan 2021
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Anabolic Steroid and Propranolol in Paediatric Burn- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05805553
- Acronym / sponsor ID
- 126/RC/KEMU
- Conditions
- Arrest, Bone, Development, Growth
- Keywords
- Pediatric, Burn, Propranolol, Steroid, Growth, arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 28 Sep 2023 (estimated)
- Study completion
- 28 Sep 2023 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
propranolol and anabolic steroids have a role in pediatric burn patients and their combined effects are to be studied here. They decrease the catabolic response to burn trauma and minimize the duration of growth arrest hence improving the outcome
Detailed description
Burn is a major cause of morbidity and mortality worldwide; rate being seven times higher in low- and middle- income countries than high income countries. According to WHO, worldwide 11million people require medical attention secondary to burns. In Pakistan, 17% of burn patients have temporary disability while 18% suffer from a permanent disability Various studies have been done to improve patient outcome in terms of morbidity and mortality. Different medical interventions seem to have promising role in improving patient outcome in burn population.
Majority of pathological problems are due to catecholamines, an integral part of systemic metabolic drive, which increase approximately 10-fold as a response to injury . Hypermetabolic state has two aspects-the "ebb" and "flow" phases. The "ebb" phase lasts till first 48hours and has decreased metabolic rate and oxygen consumption while "flow" phase, which starts after resuscitation and has huge metabolic turnover, is the problematic one and needs intervention to decrease grave outcomes on patient's health. Systemic effects of catecholamines are significant once burned surface area increases more than 20% of the TBSA and persist for years . Various studies show that Propranolol and Oxandrolone have beneficial effects on decreasing morbidity and mortality in burn population Propranolol, a non-selective beta adrenergic blocker, has been used to minimize systemic effects of catecholamines and hypothetically results in anti-catabolic effects especially when given during ebb phase of the process i.e. decreases heart rate (HR) and blood pressure (BP) while during flow phase it increases hematocrit levels by increasing the renal erythropoietin secretion and decreases number of transfusions as well as blood loss during skin grafting "Herndon et al demonstrated that the cardiac effort was significantly reduced by 20% to 36% when the patients were given 2 mg/kg every 24 hours for 5 days. They determined that an ideal dose of 0.5 to 1.0 mg/kg intravenously every 6 to 8 hours should be given to adequately reduce left ventricular work without adversely affecting oxygen delivery or other cardiac functions" In another study done by Minifee et al, propranolol does not affect overall body delivery and consumption of oxygen but significantly decreases cardiac muscle requirement of oxygen . Moreover hyper-/hypo-glycemia, hypotension, azotemia, hypothermia, arrythmias and peripheral ischemia are also not observed as adverse effects . Another study by Baron et al showed that prolonged administration of oral or IV propranolol does not have an adverse effect on morbidity or mortality
Anabolic steroid (Oxandrolone/nandrolone) has a definite role in building up body's protein stores. Unlike testosterone, its adverse effects, acne, hirsutism, behavioral changes and liver functions are not documented, so they are considered safe. Use of oxandrolone alone and in combination with propranolol has a definitive effect as anti-catabolic agent and helps in better recovery and long-term outcomes on child's growth and decreases cardiac load.
A study done by Sylvia Ojeda et al at university of Texan in 2018 showed that propranolol is both safe and effective in managing the cardiovascular effects of hypermetabolic state in burn patients. A couple of other studies show that both propranolol and oxandrolone have a role in reducing the burden of disease in burn but data is lacking on effects of administration of both the drugs combined. Moreover, how the medication will affect our population is yet to be determined. This study will help us compare the effects of both drugs in our population and decrease the morbidity and mortality in burn patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Three groups are made. one will receive steroid (control group). other will receive propranolol and third will receive both propranolol and steroid. their results will be compared
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: PropranololPropranolol will be given to this group |
| group b | Experimental | Drug: Nandrolone Decanoatesteroid will be given |
| group c | Experimental | Drug: Propranolol, Drug: Nandrolone Decanoateboth propranolol and steroids will be given |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients presenting within 48 hours of burn
- more than 20% and less than 40 %of TBSA burn (measured via modified rule of nine for pediatric burn according to age)
- age 2-12 years (as safety of anabolic steroids is not established in <2years of age)
- Scald and flame burn
Key exclusion criteria (6 listed)
- Diabetics (diagnosed before hospital admission)
- Renal disease (diagnosed before hospital admission)
- Asthmatics (on medication previously)
- Cardiac anomalies (previously diagnosed)
- Patients requiring cardiac support (norepinephrine, dobutamine at any dose and dopamine >7ug/kg).
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 |
|---|---|---|
| Propranolol2mg/kg/day in 3-4 dividd doses | Drug | Group A, group c |
| Nandrolone Decanoate1mg/kg weekly | Drug | group b, group c |
Primary outcome
reversal of growth arrest
Time frame: at 1 year after burn
BMI in kg/m^2
Bone mineral density measure
Time frame: at 1 year
Bone mineral density as g/cm^2 (Z-score)
1 secondary outcome
no of blood transfusions
Time frame: at 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propranolol and Nandrolone Decanoate in people with Arrest and Bone, run by King Edward Medical University at 1 site in Pakistan.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Apr 2023. 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 Pakistan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azwa Janjua (03326223344, azwamunim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reversal of growth arrest (time frame: at 1 year after burn). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2023.