BurnsABRUPTNCT03144427
The Acute Burn Resuscitation Multicenter Prospective Observational Trial
An observational study of Burns and Shock, run by American Burn Association at 1 site in United States.
Trial summary
This is a prospective, non-interventional, observational study of consecutive burn patients admitted to 20 selected burn centers in North America. Primarily, data collection will be continuous "real-time" documentation of fluid infusion rates, vital signs and laboratory values of patients receiving fluid resuscitation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Type of treatment
- Injection or infusion
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2017to 15 Jul 2021
- Phase
- Observational
- 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
Study population: Patients must be ≥ 18 years of age with a TBSA burn of ≥ 20%, and they must have been admitted to the burn center ≤ 12 hours following the injury.
Who may be able to join
- Age ≥ 18 years
- ≥ 20% TBSA burns
- Admitted to the burn center ≤ 12 post injury
Who cannot join
- Significant associated trauma
- High voltage (≥ 1000 volts) electrical burns
- Surgery anticipated within 48 hours from injury
- Fresh frozen plasma (FFP) anticipated to be given at any time ≤ 48 hours from injury
- Hypertonic saline (HTS) anticipated to be given at any time ≤ 48 hours from injury
- Hydroxyethyl starch (HES) anticipated to be given at any time ≤ 48 hours from injury
- High dose Vitamin C infusion is anticipated to be given at any time ≤ 48 hours from injury
- Death occurs or comfort measures are instituted within ≤ 48 hours from injury
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Medical Center-Regional Burn Center
Sacramento, California, 95817
About this study
This is a prospective, non-interventional, observational study of consecutive burn patients admitted to 20 selected burn centers in North America. Primarily, data collection will be continuous "real-time" documentation of fluid infusion rates, vital signs and laboratory values of patients receiving fluid resuscitation during the first 48 hours following burn injury. All aspects of the resuscitation and all investigations performed will be according to the participating center's regular protocol, as this is purely an observational and non-interventional study. Further data collection on outcomes (organ function, ventilation duration, length of stay, and survival) will be collected at 72h, 96 h, and at hospital discharge.
Read the detailed description
This is a prospective observational study with no intervention. Study sites have been selected to include wide cross-representation of resuscitation practices using crystalloids alone, crystalloid plus albumin, and among sites that use albumin, variable approaches to the timing of albumin initiation.
Detailed data will be continuously collected in "real time" during fluid resuscitation over the 1st 48 hours following a burn injury. Data collection during this phase will be done prospectively, hour-by-hour, by the bedside nurse caring for the patient. Primarily this data collection will involve recording of resuscitation fluid volumes, urinary output, vital signs (heart rate and blood pressure), and use of vasopressors and inotropes. Outcome data (organ function, need for mechanical ventilation, hospital length of stay, and survival) will be collected at various time points during the subjects' acute care stay.
At completion of the study we intend to make the following comparisons:
- Subjects that received crystalloids only compared to subjects that received crystalloids plus albumin.
- Subjects that had albumin started "early" (< 8 hours post burn), compared to subjects that had albumin started "intermediate" (8-12 hours post burn), compared to subjects that had albumin started "late" (>12 hours post burn).
- Characteristics of resuscitation prior to the start of albumin ("pre-albumin") compared to characteristics of resuscitation following initiation of albumin ("post albumin").
- Keywords
- albumin, resuscitation, burns, shock, fluid creep
- Medical subject headings
- Burns, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Burns | Patients with burns to 20% or more of their BSA (body surface area) require resuscitation with intravenous crystalloid fluids in order to avoid organ failure and death |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid resuscitation volume
Total fluid resuscitation volume in mL/kg/% TBSA (total body surface area) burn
Measured: 24 hours post burn injury
albumin : crystalloid ratio
albumin : crystalloid ratio ( mL albumin : mL crystalloid, and, grams albumin : mL crystalloid)
Measured: 24 hours hours post burn injury
Fluid resuscitation volume
Total fluid resuscitation volume in mL/kg/% TBSA burn
Measured: 48 hours post burn injury
albumin : crystalloid ratio
albumin : crystalloid ratio ( mL albumin : mL crystalloid, and, grams albumin : mL crystalloid)
Measured: 48 hours post burn injury
Secondary outcomes (18)
I/O Ratio
Total intake and output ratio
Measured: 24 hours post burn injury
I/O Ratio
Total intake and output ratio
Measured: 48 hours post burn injury
Doses of vasopressors and inotropes
Total doses of vasopressors and inotropes
Measured: 24 hours post burn injury
Doses of vasopressors and inotropes
Total doses of vasopressors and inotropes
Measured: 48 hours post burn injury
Fasciotomy
Documentation of fasciotomy performed
Measured: during the first 48 hours post burn injury
abdominal compartment syndrome
Occurrence of abdominal compartment syndrome
Measured: during the first 48 hours post burn injury
completion of resuscitation
Time to completion of resuscitation
Measured: up to 48 hours post burn injury
AKIN Score (acute kidney injury network)
Acute Kidney Injury Network stage
Measured: 24 hours post burn injury
AKIN Score
Acute Kidney Injury Network stage
Measured: 48 hours post burn injury
AKIN Score
Acute Kidney Injury Network stage
Measured: 72 hours post burn injury
AKIN Score
Acute Kidney Injury Network stage
Measured: 96 hours post burn injury
SOFA score (sequential organ failure assessment)
Sequential Organ Failure Assessment
Measured: 24 hours post burn injury
SOFA score
Sequential Organ Failure Assessment
Measured: 48 hours post burn injury
SOFA score
Sequential Organ Failure Assessment
Measured: 72 hours post burn injury
SOFA score
Sequential Organ Failure Assessment
Measured: 96 hours post burn injury
Mechanical Ventilation
Duration of mechanical ventilation and ventilator free days
Measured: from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months
Hospital Stay
Length of hospital stay
Measured: from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months
Survival
In hospital and 28 day survival
Measured: 28 days post burn injury or death, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start24 Feb 2017
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Burn Association
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research Acquisition Activity, University of California, Davis
- Responsible party
- Sponsor
- Investigators
- David Greenhalgh, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144427
- Sponsor's protocol ID
- ABuRN-001
- Other IDs
- W81XWH-16-2-0048 Log#MB150076
- Acronym
- ABRUPT
- Status last verified
- Jul 2021
- First submitted
- 27 Apr 2017
- Last updated
- 21 Jul 2021
- 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 17414612Holcomb JB, del Junco DJ, Fox EE, Wade CE, Cohen MJ, Schreiber MA, Alarcon LH, Bai Y, Brasel KJ, Bulger EM, Cotton BA, Matijevic N, Muskat P, Myers JG, Phelan HA, White CE, Zhang J, Rahbar MH; PROMMTT Study Group. The prospective, observational, multicenter, major trauma transfusion (PROMMTT) study: comparative effectiveness of a time-varying treatment with competing risks. JAMA Surg. 2013 Feb;148(2):127-36. doi: 10.1001/2013.jamasurg.387.
PubMed 23560283Holcomb JB, Fox EE, Wade CE; PROMMTT Study Group. The PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study. J Trauma Acute Care Surg. 2013 Jul;75(1 Suppl 1):S1-2. doi: 10.1097/TA.0b013e3182983876. No abstract available.
PubMed 23778505Rahbar MH, Fox EE, del Junco DJ, Cotton BA, Podbielski JM, Matijevic N, Cohen MJ, Schreiber MA, Zhang J, Mirhaji P, Duran SJ, Reynolds RJ, Benjamin-Garner R, Holcomb JB; PROMMTT Investigators. Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study. Resuscitation. 2012 Apr;83(4):459-64. doi: 10.1016/j.resuscitation.2011.09.019. Epub 2011 Oct 12.
PubMed 22001613Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.
PubMed 25647203Cartotto 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 4973463Baxter CR, Marvin J, Curreri PW. Fluid and electrolyte therapy of burn shock. Heart Lung. 1973 Sep-Oct;2(5):707-13. No abstract available.
PubMed 4490375Pruitt 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 12142578Engrav LH, Colescott PL, Kemalyan N, Heimbach DM, Gibran NS, Solem LD, Dimick AR, Gamelli RL, Lentz CW. A biopsy of the use of the Baxter formula to resuscitate burns or do we do it like Charlie did it? J Burn Care Rehabil. 2000 Mar-Apr;21(2):91-5. doi: 10.1097/00004630-200021020-00002.
PubMed 10752739
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Burn Resuscitation Multicenter Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT03144427
- Acronym / sponsor ID
- ABRUPT / ABuRN-001
- Keywords
- albumin, resuscitation, burns, shock, fluid creep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- American Burn AssociationUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research Acquisition Activity, University of California, Davis
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 8 May 2017 (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, non-interventional, observational study of consecutive burn patients admitted to 20 selected burn centers in North America. Primarily, data collection will be continuous "real-time" documentation of fluid infusion rates, vital signs and laboratory values of patients receiving fluid resuscitation during the first 48 hours following burn injury. All aspects of the resuscitation and all investigations performed will be according to the participating center's regular protocol, as this is purely an observational and non-interventional study. Further data collection on outcomes (organ function, ventilation duration, length of stay, and survival) will be collected at 72h, 96 h, and at hospital discharge.
Detailed description
This is a prospective observational study with no intervention. Study sites have been selected to include wide cross-representation of resuscitation practices using crystalloids alone, crystalloid plus albumin, and among sites that use albumin, variable approaches to the timing of albumin initiation.
Detailed data will be continuously collected in "real time" during fluid resuscitation over the 1st 48 hours following a burn injury. Data collection during this phase will be done prospectively, hour-by-hour, by the bedside nurse caring for the patient. Primarily this data collection will involve recording of resuscitation fluid volumes, urinary output, vital signs (heart rate and blood pressure), and use of vasopressors and inotropes. Outcome data (organ function, need for mechanical ventilation, hospital length of stay, and survival) will be collected at various time points during the subjects' acute care stay.
At completion of the study we intend to make the following comparisons:
- Subjects that received crystalloids only compared to subjects that received crystalloids plus albumin.
- Subjects that had albumin started "early" (< 8 hours post burn), compared to subjects that had albumin started "intermediate" (8-12 hours post burn), compared to subjects that had albumin started "late" (>12 hours post burn).
- Characteristics of resuscitation prior to the start of albumin ("pre-albumin") compared to characteristics of resuscitation following initiation of albumin ("post albumin").
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Burns | – | –Patients with burns to 20% or more of their BSA (body surface area) require resuscitation with intravenous crystalloid fluids in order to avoid organ failure and death |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients must be ≥ 18 years of age with a TBSA burn of ≥ 20%, and they must have been admitted to the burn center ≤ 12 hours following the injury.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- ≥ 20% TBSA burns
- Admitted to the burn center ≤ 12 post injury
Key exclusion criteria (8 listed)
- Significant associated trauma
- High voltage (≥ 1000 volts) electrical burns
- Surgery anticipated within 48 hours from injury
- Fresh frozen plasma (FFP) anticipated to be given at any time ≤ 48 hours from injury
- Hypertonic saline (HTS) anticipated to be 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.
Primary outcome
Fluid resuscitation volume
Time frame: 24 hours post burn injury
Total fluid resuscitation volume in mL/kg/% TBSA (total body surface area) burn
albumin : crystalloid ratio
Time frame: 24 hours hours post burn injury
albumin : crystalloid ratio ( mL albumin : mL crystalloid, and, grams albumin : mL crystalloid)
Fluid resuscitation volume
Time frame: 48 hours post burn injury
Total fluid resuscitation volume in mL/kg/% TBSA burn
albumin : crystalloid ratio
Time frame: 48 hours post burn injury
albumin : crystalloid ratio ( mL albumin : mL crystalloid, and, grams albumin : mL crystalloid)
18 secondary outcomes
I/O Ratio
Time frame: 24 hours post burn injury
I/O Ratio
Time frame: 48 hours post burn injury
Doses of vasopressors and inotropes
Time frame: 24 hours post burn injury
Doses of vasopressors and inotropes
Time frame: 48 hours post burn injury
Fasciotomy
Time frame: during the first 48 hours post burn injury
abdominal compartment syndrome
Time frame: during the first 48 hours post burn injury
completion of resuscitation
Time frame: up to 48 hours post burn injury
AKIN Score (acute kidney injury network)
Time frame: 24 hours post burn injury
AKIN Score
Time frame: 48 hours post burn injury
AKIN Score
Time frame: 72 hours post burn injury
AKIN Score
Time frame: 96 hours post burn injury
SOFA score (sequential organ failure assessment)
Time frame: 24 hours post burn injury
SOFA score
Time frame: 48 hours post burn injury
SOFA score
Time frame: 72 hours post burn injury
SOFA score
Time frame: 96 hours post burn injury
Mechanical Ventilation
Time frame: from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months
Hospital Stay
Time frame: from date of hospital admit until date of hospital discharge, assessed over duration of hospitalization up to 12 months
Survival
Time frame: 28 days post burn injury or death, whichever occurs first
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 21 Jul 2021.
- 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 23560283Holcomb JB, del Junco DJ, Fox EE, Wade CE, Cohen MJ, Schreiber MA, Alarcon LH, Bai Y, Brasel KJ, Bulger EM, Cotton BA, Matijevic N, Muskat P, Myers JG, Phelan HA, White CE, Zhang J, Rahbar MH; PROMMTT Study Group. The prospective, observational, multicenter, major trauma transfusion (PROMMTT) study: comparative effectiveness of a time-varying treatment with competing risks. JAMA Surg. 2013 Feb;148(2):127-36. doi: 10.1001/2013.jamasurg.387.
- Background: PubMed 23778505Holcomb JB, Fox EE, Wade CE; PROMMTT Study Group. The PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study. J Trauma Acute Care Surg. 2013 Jul;75(1 Suppl 1):S1-2. doi: 10.1097/TA.0b013e3182983876. No abstract available.
- Background: PubMed 22001613Rahbar MH, Fox EE, del Junco DJ, Cotton BA, Podbielski JM, Matijevic N, Cohen MJ, Schreiber MA, Zhang J, Mirhaji P, Duran SJ, Reynolds RJ, Benjamin-Garner R, Holcomb JB; PROMMTT Investigators. Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study. Resuscitation. 2012 Apr;83(4):459-64. doi: 10.1016/j.resuscitation.2011.09.019. Epub 2011 Oct 12.
- Background: PubMed 25647203Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.
- 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 4490375Baxter CR, Marvin J, Curreri PW. Fluid and electrolyte therapy of burn shock. Heart Lung. 1973 Sep-Oct;2(5):707-13. 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
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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.
David Greenhalgh, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns and Shock, run by American Burn Association 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 8 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 21 Jul 2021. 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.
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?
Fluid resuscitation volume (time frame: 24 hours post burn injury). The study lists 4 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 NCT03144427, which also lists 32 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 21 Jul 2021.