Burn InjuryABRUPT2NCT04356859
The Acute Burn ResUscitation Multicenter Prospective Trial
A study testing Albumin Human in people with Burn Injury, run by American Burn Association at 26 sites in 2 countries.
Trial summary
This is a prospective randomized multi-center study which will compare acute fluid resuscitation using a colloid strategy (LR + 5% Albumin) to a crystalloid strategy (LR alone), in adults with an acute burn involving at least 25% of their total body surface area. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Injury
- What is being tested?
- Albumin Human
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 22 Apr 2021to 29 Sep 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Total burn size (second and third degree) is ≥ 25% of the TBSA
- Burn center admission within 12 hours of injury.
- There is a plan for formal fluid resuscitation.
Who cannot join
- Significant associated trauma
- High voltage (≥ 1000 volts) electrical burns
- Burn wound excision surgery within 48 hours from injury
- Fresh frozen plasma (FFP) given at any time ≤ 48 hours from injury
- Hypertonic saline (HTS) given at any time ≤ 48 hours from injury
- Hydroxyethyl starch (HES) given at any time ≤ 48 hours from injury
Show all 13Show fewer
- High dose Vitamin C infusion given at any time ≤ 48 hours from injury
- Administration of human albumin prior to randomization
- Palliative comfort measures are instituted ≤ 48 hours from injury
- Pregnancy
- Pre-injury chronic renal insufficiency equal to or greater than stage 3
- Pre-injury chronic hepatic disease (Child-Pugh B or C)
- Pre-injury left ventricular (LV) dysfunction (echocardiography LV grade II-IV or ejection fraction ≤ 35%)
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States24 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Erie County Medical Center
Buffalo, New York, 14215
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
Metrohealth Medical Center
Cleveland, Ohio, 44109
University of Florida Health
Gainesville, Florida, 32608
University of Iowa Healthcare
Iowa City, Iowa, 52242
University of Kansas Health System
Kansas City, Kansas, 66160
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
University of Wisconsin Health
Madison, Wisconsin, 53792
Loyola Medicine
Maywood, Illinois, 60153
The University of Tennessee Health Science Center
Memphis, Tennessee, 38163
University of Miami Health System
Miami, Florida, 33136
Hennepin Healthcare
Minneapolis, Minnesota, 55404
Arizona Burn Center Valleywise Health
Phoenix, Arizona, 85008
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
Legacy Health
Portland, Oregon, 97227
University of California Davis, Regional Burn Center
Sacramento, California, 95817
University of Utah Health
Salt Lake City, Utah, 84132
Regional Burn Center at Harborview
Seattle, Washington, 98014
University of South Florida
Tampa, Florida, 33606
Torrance Memorial
Torrance, California, 90505
Westchester Medical Center Health Network
Valhalla, New York, 10595
Ascension Via Christi St. Francis
Wichita, Kansas, 67214
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Canada2 sites
University of Alberta
Edmonton, Alberta, AB T6G 1Z1
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
About this study
Official title: The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)
This is a prospective randomized multi-center study which will compare acute fluid resuscitation using a colloid strategy (LR + 5% Albumin) to a crystalloid strategy (LR alone), in adults with an acute burn involving at least 25% of their total body surface area.
Read the detailed description
Enrolled subjects will be randomly assigned to either the Colloid Group or the Crystalloid Group. Randomization will be based on an intent-to-treat basis. In order to ensure that the two groups have comparable injury severity at baseline, randomization will be block- stratified based on age (18-50 and > 50 years), burn size (25-50% and > 50% TBSA), and presence of inhalation injury confirmed by bronchoscopy (present or absent). In the Colloid Group resuscitation starts with LR and then 5% albumin will be introduced between 8 and 12 hours post burn in a ratio of 1/3 albumin to 2/3 LR. In the Crystalloid Group resuscitation is with LR only. Each group will have their study fluid maintained for the 1st 48 hours post burn and study fluids in each group will be identically titrated to the urinary output.
- Conditions
- Burn Injury
- Being tested
- Albumin Human
- Keywords
- Resuscitation
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin HumanDrug
Also called albumin
Addition of albumin during acute resuscitation following burn injury
| Study group | Role | What they receive |
|---|---|---|
| Crystalloid | No intervention | Subjects in the crystalloid group will receive fluid resuscitation with Lactated Ringer's titrated each hour to achieve a urine output of 0.5-1mL/kg predicted body weight. |
| Colloid | Active comparator | Subjects in the colloid group will receive fluid resuscitation with Lactated Ringer's and 5% human albumin solution introduced no earlier than 8 hours post burn and no later than 12 hours post burn in a ratio by volume of 1/3 albumin to 2/3 Lactated Ringer's, and titrated each hour to achieve a urine output of 0.5-1mL/kg (milliliter/kilogram) predicted body weight. Receives: Drug: Albumin Human |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of fluid received during resuscitation for burn injury
Total fluid resuscitation volume at 24 hours post burn in mL/kg/% TBSA burn
Measured: 24 hours post burn injury
Secondary outcomes (13)
Volume of fluid received during resuscitation for burn injury
Total resuscitation volume at 48 hours in mL/kg/%TBSA burn.
Measured: 48 hours post burn injury
Urine output during resuscitation for burn injury
Mean hourly urine output during resuscitation for burn injury
Measured: 24 and 48 hours post burn injury
Number of crossovers
Number of crossovers between study arms during resuscitation for burn injury
Measured: 48 hours post burn injury
Peak lactate and delta lactate
peak lactate level and delta lactate (peak lactate minus admission lactate)
Measured: 48 hours post burn injury
Peak intra-abdominal pressure (IAP) and delta IAP
Peak intra-abdominal pressure (IAP) and delta IAP (peak IAP minus admission IAP)
Measured: 48 hours post burn injury
Occurrence of Abdominal compartment syndrome
Abdominal compartment syndrome during resuscitation for burn injury
Measured: 48 hours post burn injury
Occurrence of Limb or abdominal fasciotomy
Limb or abdominal fasciotomy during resuscitation for burn injury
Measured: 48 hours post burn injury
Sequential Organ Failure Assessment (SOFA) score
Assessment of organ function or failure by Sequential Organ Failure Assessment (SOFA)score, with the higher score(s) indicating organ failure
Measured: 48, 72, and 96 hours post burn injury
Acute kidney injury (AKI)
Diagnosis of AKI
Measured: 96 hours post burn injury
Duration of intubation/mechanical ventilation
Duration of intubation/mechanical ventilation
Measured: 96 hours post burn injury
PaO2/FiO2 ratios
PaO2(partial pressure of oxygen)/FiO2(fraction of inspired oxygen inspired oxygen) ratios
Measured: 24, 48, 72, and 96 hours post burn injury
Time to wound healing
Time to wound healing defined as 7 days post last grafting surgery
Measured: 7 days post last surgery for grafting of burn injury
Survival
28 day survival and hospital stay survival
Measured: 28 days post injury and hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start22 Apr 2021
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Burn InjuryStudies 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
- Parallel groups
- Model description
- Randomization will be based on "intent to treat." Consecutively admitted and eligible burn patients will be assigned to one of two treatment groups (Colloid or Crystalloid) within 12 hours of burn injury.
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Burn Association
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- David G Greenhalgh, MD, Principal investigator, UC Davis Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356859
- Sponsor's protocol ID
- 1528946
- Other IDs
- CDMRP-JW180038
- Acronym
- ABRUPT2
- Status last verified
- May 2026
- First submitted
- 16 Apr 2020
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pruitt BA Jr. Protection from excessive resuscitation: "pushing the pendulum back". J Trauma. 2000 Sep;49(3):567-8. doi: 10.1097/00005373-200009000-00030. No abstract available.
PubMed 11003341Zak AL, Harrington DT, Barillo DJ, Lawlor DF, Shirani KZ, Goodwin CW. Acute respiratory failure that complicates the resuscitation of pediatric patients with scald injuries. J Burn Care Rehabil. 1999 Sep-Oct;20(5):391-9. doi: 10.1097/00004630-199909000-00011.
PubMed 10501327Hobson KG, Young KM, Ciraulo A, Palmieri TL, Greenhalgh DG. Release of abdominal compartment syndrome improves survival in patients with burn injury. J Trauma. 2002 Dec;53(6):1129-33; discussion 1133-4. doi: 10.1097/00005373-200212000-00016.
PubMed 12478039Klein MB, Hayden D, Elson C, Nathens AB, Gamelli RL, Gibran NS, Herndon DN, Arnoldo B, Silver G, Schoenfeld D, Tompkins RG. The association between fluid administration and outcome following major burn: a multicenter study. Ann Surg. 2007 Apr;245(4):622-8. doi: 10.1097/01.sla.0000252572.50684.49.
PubMed 17414612Recinos PR, Hartford CA, Ziffren SE. Fluid resuscitation of burn patients comparing a crystalloid with a colloid containing solution: a prospective study. J Iowa Med Soc. 1975 Oct;65(10):426-32. No abstract available.
PubMed 1194720Goodwin CW, Dorethy J, Lam V, Pruitt BA Jr. Randomized trial of efficacy of crystalloid and colloid resuscitation on hemodynamic response and lung water following thermal injury. Ann Surg. 1983 May;197(5):520-31. doi: 10.1097/00000658-198305000-00004.
PubMed 6342554Cooper AB, Cohn SM, Zhang HS, Hanna K, Stewart TE, Slutsky AS; ALBUR Investigators. Five percent albumin for adult burn shock resuscitation: lack of effect on daily multiple organ dysfunction score. Transfusion. 2006 Jan;46(1):80-9. doi: 10.1111/j.1537-2995.2005.00667.x.
PubMed 16398734O'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 15920417Muller Dittrich MH, Brunow de Carvalho W, Lopes Lavado E. Evaluation of the "Early" Use of Albumin in Children with Extensive Burns: A Randomized Controlled Trial. Pediatr Crit Care Med. 2016 Jun;17(6):e280-6. doi: 10.1097/PCC.0000000000000728.
PubMed 27077832Cartotto R, Callum J. A review of the use of human albumin in burn patients. J Burn Care Res. 2012 Nov-Dec;33(6):702-17. doi: 10.1097/BCR.0b013e31825b1cf6.
PubMed 23143614Baxter CR, Shires T. Physiological response to crystalloid resuscitation of severe burns. Ann N Y Acad Sci. 1968 Aug 14;150(3):874-94. doi: 10.1111/j.1749-6632.1968.tb14738.x. No abstract available.
PubMed 4973463Pruitt BA Jr. Fluid and electrolyte replacement in the burned patient. Surg Clin North Am. 1978 Dec;58(6):1291-1312. doi: 10.1016/s0039-6109(16)41692-0. No abstract available.
PubMed 734610Pruitt BA Jr. The burn patient: II. Later care and complications of thermal injury. Curr Probl Surg. 1979 May;16(5):1-95. doi: 10.1016/s0011-3840(79)80009-x.
PubMed 376227Cartotto RC, Innes M, Musgrave MA, Gomez M, Cooper AB. How well does the Parkland formula estimate actual fluid resuscitation volumes? J Burn Care Rehabil. 2002 Jul-Aug;23(4):258-65. doi: 10.1097/00004630-200207000-00006.
PubMed 12142578Cartotto R, Zhou A. Fluid creep: the pendulum hasn't swung back yet! J Burn Care Res. 2010 Jul-Aug;31(4):551-8. doi: 10.1097/BCR.0b013e3181e4d732.
PubMed 20616649
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Burn ResUscitation Multicenter Prospective Trial (ABRUPT2)
- ClinicalTrials.gov ID
- NCT04356859
- Acronym / sponsor ID
- ABRUPT2 / 1528946
- Conditions
- Burn Injury
- Keywords
- Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- American Burn AssociationUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 22 Apr 2020 (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.
This is a prospective randomized multi-center study which will compare acute fluid resuscitation using a colloid strategy (LR + 5% Albumin) to a crystalloid strategy (LR alone), in adults with an acute burn involving at least 25% of their total body surface area.
Detailed description
Enrolled subjects will be randomly assigned to either the Colloid Group or the Crystalloid Group. Randomization will be based on an intent-to-treat basis. In order to ensure that the two groups have comparable injury severity at baseline, randomization will be block- stratified based on age (18-50 and > 50 years), burn size (25-50% and > 50% TBSA), and presence of inhalation injury confirmed by bronchoscopy (present or absent). In the Colloid Group resuscitation starts with LR and then 5% albumin will be introduced between 8 and 12 hours post burn in a ratio of 1/3 albumin to 2/3 LR. In the Crystalloid Group resuscitation is with LR only. Each group will have their study fluid maintained for the 1st 48 hours post burn and study fluids in each group will be identically titrated to the urinary output.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization will be based on "intent to treat." Consecutively admitted and eligible burn patients will be assigned to one of two treatment groups (Colloid or Crystalloid) within 12 hours of burn injury.
| Arm | Type | Receives |
|---|---|---|
| Crystalloid | No intervention | –Subjects in the crystalloid group will receive fluid resuscitation with Lactated Ringer's titrated each hour to achieve a urine output of 0.5-1mL/kg predicted body weight. |
| Colloid | Active comparator | Drug: Albumin HumanSubjects in the colloid group will receive fluid resuscitation with Lactated Ringer's and 5% human albumin solution introduced no earlier than 8 hours post burn and no later than 12 hours post burn in a ratio by volume of 1/3 albumin to 2/3 Lactated Ringer's, and titrated each hour to achieve a urine output of 0.5-1mL/kg (milliliter/kilogram) predicted body weight. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Total burn size (second and third degree) is ≥ 25% of the TBSA
- Burn center admission within 12 hours of injury.
- There is a plan for formal fluid resuscitation.
Key exclusion criteria (13 listed)
- Significant associated trauma
- High voltage (≥ 1000 volts) electrical burns
- Burn wound excision surgery within 48 hours from injury
- Fresh frozen plasma (FFP) given at any time ≤ 48 hours from injury
- Hypertonic saline (HTS) given at any time ≤ 48 hours from injury
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 |
|---|---|---|
| Albumin HumanAlso: albuminAddition of albumin during acute resuscitation following burn injury | Drug | Colloid |
Primary outcome
Volume of fluid received during resuscitation for burn injury
Time frame: 24 hours post burn injury
Total fluid resuscitation volume at 24 hours post burn in mL/kg/% TBSA burn
13 secondary outcomes
Volume of fluid received during resuscitation for burn injury
Time frame: 48 hours post burn injury
Urine output during resuscitation for burn injury
Time frame: 24 and 48 hours post burn injury
Number of crossovers
Time frame: 48 hours post burn injury
Peak lactate and delta lactate
Time frame: 48 hours post burn injury
Peak intra-abdominal pressure (IAP) and delta IAP
Time frame: 48 hours post burn injury
Occurrence of Abdominal compartment syndrome
Time frame: 48 hours post burn injury
Occurrence of Limb or abdominal fasciotomy
Time frame: 48 hours post burn injury
Sequential Organ Failure Assessment (SOFA) score
Time frame: 48, 72, and 96 hours post burn injury
Acute kidney injury (AKI)
Time frame: 96 hours post burn injury
Duration of intubation/mechanical ventilation
Time frame: 96 hours post burn injury
PaO2/FiO2 ratios
Time frame: 24, 48, 72, and 96 hours post burn injury
Time to wound healing
Time frame: 7 days post last surgery for grafting of burn injury
Survival
Time frame: 28 days post injury and hospital discharge
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 20 May 2026.
- Background: PubMed 11003341Pruitt BA Jr. Protection from excessive resuscitation: "pushing the pendulum back". J Trauma. 2000 Sep;49(3):567-8. doi: 10.1097/00005373-200009000-00030. No abstract available.
- Background: PubMed 10501327Zak AL, Harrington DT, Barillo DJ, Lawlor DF, Shirani KZ, Goodwin CW. Acute respiratory failure that complicates the resuscitation of pediatric patients with scald injuries. J Burn Care Rehabil. 1999 Sep-Oct;20(5):391-9. doi: 10.1097/00004630-199909000-00011.
- Background: PubMed 12478039Hobson KG, Young KM, Ciraulo A, Palmieri TL, Greenhalgh DG. Release of abdominal compartment syndrome improves survival in patients with burn injury. J Trauma. 2002 Dec;53(6):1129-33; discussion 1133-4. doi: 10.1097/00005373-200212000-00016.
- Background: PubMed 17414612Klein MB, Hayden D, Elson C, Nathens AB, Gamelli RL, Gibran NS, Herndon DN, Arnoldo B, Silver G, Schoenfeld D, Tompkins RG. The association between fluid administration and outcome following major burn: a multicenter study. Ann Surg. 2007 Apr;245(4):622-8. doi: 10.1097/01.sla.0000252572.50684.49.
- Background: PubMed 1194720Recinos PR, Hartford CA, Ziffren SE. Fluid resuscitation of burn patients comparing a crystalloid with a colloid containing solution: a prospective study. J Iowa Med Soc. 1975 Oct;65(10):426-32. No abstract available.
- Background: PubMed 6342554Goodwin CW, Dorethy J, Lam V, Pruitt BA Jr. Randomized trial of efficacy of crystalloid and colloid resuscitation on hemodynamic response and lung water following thermal injury. Ann Surg. 1983 May;197(5):520-31. doi: 10.1097/00000658-198305000-00004.
- Background: PubMed 16398734Cooper AB, Cohn SM, Zhang HS, Hanna K, Stewart TE, Slutsky AS; ALBUR Investigators. Five percent albumin for adult burn shock resuscitation: lack of effect on daily multiple organ dysfunction score. Transfusion. 2006 Jan;46(1):80-9. doi: 10.1111/j.1537-2995.2005.00667.x.
- 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 27077832Muller Dittrich MH, Brunow de Carvalho W, Lopes Lavado E. Evaluation of the "Early" Use of Albumin in Children with Extensive Burns: A Randomized Controlled Trial. Pediatr Crit Care Med. 2016 Jun;17(6):e280-6. doi: 10.1097/PCC.0000000000000728.
- Background: PubMed 23143614Cartotto R, Callum J. A review of the use of human albumin in burn patients. J Burn Care Res. 2012 Nov-Dec;33(6):702-17. doi: 10.1097/BCR.0b013e31825b1cf6.
- Background: PubMed 4973463Baxter CR, Shires T. Physiological response to crystalloid resuscitation of severe burns. Ann N Y Acad Sci. 1968 Aug 14;150(3):874-94. doi: 10.1111/j.1749-6632.1968.tb14738.x. No abstract available.
- Background: PubMed 734610Pruitt BA Jr. Fluid and electrolyte replacement in the burned patient. Surg Clin North Am. 1978 Dec;58(6):1291-1312. doi: 10.1016/s0039-6109(16)41692-0. No abstract available.
- Individual participant dataSharing planned: No
Related trials for 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
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
Recruiting
Efferon LPS Hemoadsorption in in Patients With Thermal Burns
Burns
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.
David G Greenhalgh, MD principal investigator
UC Davis Health
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albumin Human in people with Burn Injury, run by American Burn Association at 26 sites in 2 countries.
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 13 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 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada. 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?
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?
Volume of fluid received during resuscitation for burn injury (time frame: 24 hours post burn injury). 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 NCT04356859, which also lists 29 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 20 May 2026.