BurnsPhase 2/3NCT06224777
Comparison of Fluid Resuscitation in Pediatric Burn Patients Using Crystalloids and With Albumin on Day Two.
A Phase 2/3 study testing 5% Albumin (human) Solution and Paeds solution in people with Burns, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
The goal of this comparative, interventional randomized controlled trial is to use albumin during resuscitation in pediatric burn patients on day 2, as it can reduce extravasation of fluids and decrease the overall fluid requirements, along with mortality and maintain circulation. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Burns
- What is being tested?
- 5% Albumin (human) Solution and Paeds solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2022to 17 May 2023
- Phase
- Phase 2/3
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 25-40%, less than 12 hours old, scald or flame burn patients
- Full thickness
Who cannot join
- Burns with inhalational injury.
- Patients hypersensitive to Albumin.
- Deranged renal or hepatic profile.
- Patients with known Cardiac or debilitating Congenital anomalies.
- Patients with known metabolic disease.
- Burns associated with trauma including fractures, head injuries, intra-abdominal bleed etc.
- Albumin level lower than 1.8g/dl at time of admission.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
King Edward Medical University, Mayo Hospital
Lahore, Punjab Province, 54000
About this study
The goal of this comparative, interventional randomized controlled trial is to use albumin during resuscitation in pediatric burn patients on day 2, as it can reduce extravasation of fluids and decrease the overall fluid requirements, along with mortality and maintain circulation.
Participants will be divided into 2 groups. Albumin will be administered additionally in group A, while only crystalloids will be used for resuscitation in group B.
Read the detailed description
The randomized controlled trial will be done at Department of Pediatric Surgery, Mayo Hospital Lahore from January 2022 to December 2022. Ninety patients (forty-five patients in each group) will be enrolled using a non probability convenient sampling technique. Patients will be randomly divided into 2 groups. Albumin solution will be administered in group A and in group B only routine crystalloids will be given. Basic demographic information will be noted. Effect modifiers (hemoglobin, Albumin level, weight and height) will be noted.
Group A: After first 24 hours, maintenance fluid, N/2+5%Dextrose solution will be started according to weight(100ml/kg/day for first 10kg, 50ml/kg/day for next 10kg and 20ml/kg/day for the remainder) and will be increased or decreased by 1/3 to maintain the urinary output to 1-1.5ml/kg/hour. 12, 75 5% Albumin solution will be administered @0.5ml/kg/%burn over initial 8 hours of day 2 and It's amount will be subtracted from the 24 hours fluid calculated earlier.
Group B: After first 24 hours, maintenance fluid, N/2+5%Dextrose solution will be started according to weight (100ml/kg/day for first 10kg, 50ml/kg/day for next 10kg and 20ml/kg/day for the remainder) and will be increased or decreased by 1/3 to maintain the urinary output to 1-1.5ml/kg/hour.
- Conditions
- Burns
- Being tested
- 5% Albumin (human) Solution, Paeds solution
- Keywords
- Albumin, Resuscitation, Pediatric Burns, Fluid creep, Shock, Crystalloids
- Medical subject headings
- Burns, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% Albumin (human) SolutionBiological
Also called ALBURX® 5
Albumin is a biological product derived from human blood donors.
Paeds solutionDrug
Also called Revasol-Paeds IV Infusion
Paeds solution contains dextrose 4.3%, and Sodium Chloride 0.18%
| Study group | Role | What they receive |
|---|---|---|
| Albumin Group A | Experimental | 5% Albumin solution will be administered on day 2 @0.5ml/kg/%burn over 8 hours,in addition to required crystalloids. Receives: Biological: 5% Albumin (human) Solution; Drug: Paeds solution |
| Crystalloid Group B | Active comparator | Routine Crystalloids will be administered according to weight of the patient. Receives: Drug: Paeds solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resuscitation Volume
Total volume of fluid required to maintain a urine output of 1-1.5ml/hour on the day 2 of admission.
Measured: 24-48 hours
Serum Albumin levels
Albumin level in patient after day 2 of admission
Measured: 24-48 hours
Urine Output
Amount of urine passed on day 2 of admission. Should be 1-2.5ml/kh/hr
Measured: 24-48 hours
Secondary outcomes (2)
Requirement of inotropic support
Patients in shock not responding to additional fluid administration, with reduced urine output requiring dopamine or dobutamine.
Measured: 24-48 hours
Mortality
Any death occuring within 5 days of admission
Measured: First 5 days of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Jan 2022
- Primary completion18 Dec 2022
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatima Naumeri, MBBS,FCPS, Principal investigator, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224777
- Sponsor's protocol ID
- 260/RC/KEMU
- Status last verified
- Sep 2023
- First submitted
- 16 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Romanowski KS, Palmieri TL. Pediatric burn resuscitation: past, present, and future. Burns Trauma. 2017 Sep 4;5:26. doi: 10.1186/s41038-017-0091-y. eCollection 2017.
PubMed 28879205O'Mara MS, Slater H, Goldfarb IW, Caushaj PF. A prospective, randomized evaluation of intra-abdominal pressures with crystalloid and colloid resuscitation in burn patients. J Trauma. 2005 May;58(5):1011-8. doi: 10.1097/01.ta.0000162732.39083.15.
PubMed 15920417Comish P, Walsh M, Castillo-Angeles M, Kuhlenschmidt K, Carlson D, Arnoldo B, Kubasiak J. Adoption of rescue colloid during burn resuscitation decreases fluid administered and restores end-organ perfusion. Burns. 2021 Dec;47(8):1844-1850. doi: 10.1016/j.burns.2021.02.005. Epub 2021 Feb 20.
PubMed 33658146
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fluid Resuscitation in Pediatric Burn Patients Using Crystalloids and With Albumin on Day Two.
- ClinicalTrials.gov ID
- NCT06224777
- Acronym / sponsor ID
- 260/RC/KEMU
- Conditions
- Burns
- Keywords
- Albumin, Resuscitation, Pediatric Burns, Fluid creep, Shock, Crystalloids
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 18 Dec 2022 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 25 Jan 2024 (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.
The goal of this comparative, interventional randomized controlled trial is to use albumin during resuscitation in pediatric burn patients on day 2, as it can reduce extravasation of fluids and decrease the overall fluid requirements, along with mortality and maintain circulation.
Participants will be divided into 2 groups. Albumin will be administered additionally in group A, while only crystalloids will be used for resuscitation in group B.
Detailed description
The randomized controlled trial will be done at Department of Pediatric Surgery, Mayo Hospital Lahore from January 2022 to December 2022. Ninety patients (forty-five patients in each group) will be enrolled using a non probability convenient sampling technique. Patients will be randomly divided into 2 groups. Albumin solution will be administered in group A and in group B only routine crystalloids will be given. Basic demographic information will be noted. Effect modifiers (hemoglobin, Albumin level, weight and height) will be noted.
Group A: After first 24 hours, maintenance fluid, N/2+5%Dextrose solution will be started according to weight(100ml/kg/day for first 10kg, 50ml/kg/day for next 10kg and 20ml/kg/day for the remainder) and will be increased or decreased by 1/3 to maintain the urinary output to 1-1.5ml/kg/hour. 12, 75 5% Albumin solution will be administered @0.5ml/kg/%burn over initial 8 hours of day 2 and It's amount will be subtracted from the 24 hours fluid calculated earlier.
Group B: After first 24 hours, maintenance fluid, N/2+5%Dextrose solution will be started according to weight (100ml/kg/day for first 10kg, 50ml/kg/day for next 10kg and 20ml/kg/day for the remainder) and will be increased or decreased by 1/3 to maintain the urinary output to 1-1.5ml/kg/hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin Group A | Experimental | Biological: 5% Albumin (human) Solution, Drug: Paeds solution5% Albumin solution will be administered on day 2 @0.5ml/kg/%burn over 8 hours,in addition to required crystalloids. |
| Crystalloid Group B | Active comparator | Drug: Paeds solutionRoutine Crystalloids will be administered according to weight of the patient. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 25-40%, less than 12 hours old, scald or flame burn patients
- Full thickness
Key exclusion criteria (7 listed)
- Burns with inhalational injury.
- Patients hypersensitive to Albumin.
- Deranged renal or hepatic profile.
- Patients with known Cardiac or debilitating Congenital anomalies.
- Patients with known metabolic disease.
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 |
|---|---|---|
| 5% Albumin (human) SolutionAlso: ALBURX® 5Albumin is a biological product derived from human blood donors. | Biological | Albumin Group A |
| Paeds solutionAlso: Revasol-Paeds IV InfusionPaeds solution contains dextrose 4.3%, and Sodium Chloride 0.18% | Drug | Albumin Group A, Crystalloid Group B |
Primary outcome
Resuscitation Volume
Time frame: 24-48 hours
Total volume of fluid required to maintain a urine output of 1-1.5ml/hour on the day 2 of admission.
Serum Albumin levels
Time frame: 24-48 hours
Albumin level in patient after day 2 of admission
Urine Output
Time frame: 24-48 hours
Amount of urine passed on day 2 of admission. Should be 1-2.5ml/kh/hr
2 secondary outcomes
Requirement of inotropic support
Time frame: 24-48 hours
Mortality
Time frame: First 5 days of admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Background: PubMed 28879205Romanowski KS, Palmieri TL. Pediatric burn resuscitation: past, present, and future. Burns Trauma. 2017 Sep 4;5:26. doi: 10.1186/s41038-017-0091-y. eCollection 2017.
- Background: PubMed 15920417O'Mara MS, Slater H, Goldfarb IW, Caushaj PF. A prospective, randomized evaluation of intra-abdominal pressures with crystalloid and colloid resuscitation in burn patients. J Trauma. 2005 May;58(5):1011-8. doi: 10.1097/01.ta.0000162732.39083.15.
- Background: PubMed 33658146Comish P, Walsh M, Castillo-Angeles M, Kuhlenschmidt K, Carlson D, Arnoldo B, Kubasiak J. Adoption of rescue colloid during burn resuscitation decreases fluid administered and restores end-organ perfusion. Burns. 2021 Dec;47(8):1844-1850. doi: 10.1016/j.burns.2021.02.005. Epub 2021 Feb 20.
- RationaleLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Burns
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
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.
Fatima Naumeri, MBBS,FCPS principal investigator
King Edward Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 5% Albumin (human) Solution and Paeds solution in people with Burns, 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 25 Jan 2024. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Resuscitation Volume (time frame: 24-48 hours). The study lists 3 primary outcomes in all. 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 NCT06224777, which also lists 3 linked publications.
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 25 Jan 2024.