Burn Body Region UnspecifiedPhase 3NCT04732624
Enteral Resuscitation Nepal (Pilot Study)
A Phase 3 study testing Oral Rehydration Solution and Lactated Ringer in people with Burn Body Region Unspecified and Burn Shock, run by University of Washington at 1 site in Nepal.
Trial summary
Nepal and the South Asian sub-continent carry some of the highest rates of burn injury globally, with an associated high morbidity and mortality. Nepal currently has one major center equipped for burn care, in Kirtipur, Nepal and receives referred patients from around the country. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Body Region Unspecified, Burn Shock
- What is being tested?
- Oral Rehydration Solution and Lactated Ringer
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNepal
- Study dates
- 30 Sep 2021to 4 Jun 2022
- Phase
- Phase 3
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
- All genders
- Adults aged ≥18 years who present with moderate-sized burn injuries [20 - 40% total body surface areas (TBSA)] to the Nepal Cleft and Burn Center within 24 hours of injury.
Who cannot join
- Patients with electrical burns, chemical burns, inhalation injury.
- Patients in overt shock (defined as serum lactate >2.5, or hypotension and altered mental status).
- Pregnant patients, psychiatrically unstable patients will be excluded.
- Patients with oropharyngeal defects and/or previously known diagnoses leading to high risk of aspiration, and/or precluding safe nasal-enteric access will be excluded.
- Patients will history of chronic nausea and/or vomiting, including those with a diagnosis of gastroparesis due to diabetes mellitus will be excluded.
- Patients with a Baux score of over 100 (age + TBSA), patients with declared palliative intent on admission, and patients for whom clinicians have high level of clinical concern based on clinical judgement will also be excluded.
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Nepal Cleft and Burn Center at Kirtipur Hospital
Ki̇̄rtipur, Bagmati
About this study
Official title: Implementation of an Enteral Resuscitation Bundle for Moderate-sized Burn Injuries (20-40% Total Body Surface Area) to Prevent Shock, Coagulopathy, and Kidney and Lung Injury in Nepal
Nepal and the South Asian sub-continent carry some of the highest rates of burn injury globally, with an associated high morbidity and mortality. Nepal currently has one major center equipped for burn care, in Kirtipur, Nepal and receives referred patients from around the country. At presentation, most patients with major burns have had minimal to no resuscitation on arrival, often hours to days after the burn injury was sustained.
Timely fluid resuscitation, initiated as soon as possible after major burn injury, is the main tenet of acute burn care. Lack of adequate resuscitation in major burn injuries leads to kidney injury, progression of burn injury, sepsis, burn shock, and death. The current standard of care for major burn resuscitation is intravenous fluid resuscitation. In Nepal, however, adequately trained and equipped hospitals for treatment of burn care are not available (for a variety of reasons). Additionally, there is not a systematic emergency medical transport system available for provision of medical care and resuscitation during transport. Enteral-based resuscitation with substances like the WHO Oral Rehydration Solution (ORS) is recommended by burn experts and the professional burn societies when resources and access to intravenous fluid resuscitation are not available in resource-constrained settings such as rural areas, low- and middle-income countries, and military battlefield scenarios. Studies have previously demonstrated the efficacy and safety of enteral-based resuscitation in controlled, high-resource settings, however there have not been real-world effectiveness trials in austere settings. Therefore, the investigators seek to ultimately address the problem of pre-hospital and pre-burn center admission resuscitation by studying the feasibility and effectiveness of enteral resuscitation with Oral Rehydration Solution (ORS) in preventing burn shock.
Read more
This study examines enteral (oral)-based resuscitation with ORS and IV Fluids versus only IV Fluids for the treatment of major burn injuries. The intervention portion of the study will entail randomization of patients presenting with acute burn injuries of 20-40% total body surface area (TBSA) to an enteral-based resuscitation versus the standard of care IV fluid resuscitation. The intervention will continue through the 24-72 hours of the acute resuscitation period.
This is a feasibility study, primarily to develop and establish the research infrastructure and practices at the study site for future pilot study and eventually randomized-controlled trial research on this intervention. The primary outcomes will be measures of feasibility such as the adherence rate to the resuscitation protocols. Further, there will be a qualitative component to the study with focus group interviews of the bedside healthcare providers (doctors and nurses) who are caring for the enrolled patients, in order to understand the challenges and facilitators of enteral resuscitation. Qualitative analysis will be done to understand the major themes of challenges and facilitators to enteral resuscitation.
- Conditions
- Burn Body Region Unspecified, Burn Shock
- Being tested
- Oral Rehydration Solution, Lactated Ringer
- Keywords
- Burns, Enteral Resuscitation, Oral Rehydration Solution, Burn Shock, Austere Conditions, Low- and middle-income country
- Medical subject headings
- Burns, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Rehydration SolutionDrug
Also called Enteral-based Resuscitation
Feasibility study of Enteral-based resuscitation with Oral Rehydration Solution (ORS) vs standard-of-care Intravenous Fluid resuscitation for moderate-sized burn injuries in Nepal
Lactated RingerDrug
Also called Intravenous Fluid Resuscitation
Standard-of-care Intravenous Fluid resuscitation
| Study group | Role | What they receive |
|---|---|---|
| Enteral-based Protocolized Resuscitation | Experimental | Administration of Enteral-based Resuscitation using Oral Rehydration Solution (ORS) either by mouth of via naso-enteric access for moderate sized burn injuries (20-40% TBSA) per resuscitation protocol for burn-injured patients. Resuscitation will be administered in the acute resuscitation phase of burn injury (24-72 hours post injury). Patients will receive supplemental Intravenous Fluid (IV Fluid) resuscitation using Lactated Ringer's solution as needed per protocol. Receives: Drug: Oral Rehydration Solution; Drug: Lactated Ringer |
| Intravenous Fluid Protocolized Resuscitation | Active comparator | Administration of Intravenous Fluid using Lactated Ringer's solution per standard of care resuscitation protocol for patients with moderate sized burn injuries (20-40% TBSA). Receives: Drug: Lactated Ringer |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 Hour Average Urine Output (UOP)
Calculated by totaling all of the recorded urine output (adding up the columns labelled HR 1-2 UO, HR 3-4 UO, etc. until HR 23-24), then dividing by their weight in Kg (column labelled Admission weight) and dividing by 24 hours. The units of this measurement will be mL/kg/hr.
Measured: 24 hours
24-hour Resuscitation Volume
Calculated by totaling the total resuscitative fluids administered in first 24 hours of resuscitation, divided by admission weight and % TBSA of burn injury. (cc/kg/% TBSA of burn injury)
Measured: 24 hours
Hours From Injury to Resuscitation
Hours calculated from point of injury to starting of resuscitation.
Measured: Point measurement (Once at the start of resuscitation)
Secondary outcomes (5)
Number of Participants With GI Discomfort
Any "check" for nausea, vomiting, distention, diarrhea
Measured: 24 hours
Number of Participants Crossover to IV Due to GI Intolerance
Number of participants crossover to standard of care (IV resuscitation) due to GI intolerance like nausea, vomitting
Measured: 24hours
Number of Participants With Acute Kidney Injury
Measured with any signs of Acute Kidney injury during first 72 hours of resuscitation according to KDIGO definition i.e., increase in serum creatinine by 0.3mg/dL or more within 48 hours or increase in serum creatinine to 1.5 times baseline or more within the last 7 days or urine output less than 0.5 mL/kg/h for 6 hours. AKI on admission was defined as a serum creatinine greater than 1.5 mg/dL with less than 0.5 mL/kg/h of urine output for the first hour. Urine output was measured every 2 hours for the first 24 hours and serum creatinine was measured on admission then 8,16,24,48 and 72 hours from the commencement of the resuscitation.
Measured: 72 hours
Participants Death Within 72 Hours of Resuscitation
Secondary resuscitation outcome measured daily within study period i.e. 72 hours of resuscitation as participant death related or associated with the study. Monitored by data safety monitoring board and if proven to be associated with the study considered serious adverse event.
Measured: 72 hours
Discharge Outcome
Outcome of hospital stay
Measured: Measured over complete course of hospitalization until discharge or death, assessed every 24 hours after enrollment in the study. Maximum timeframe 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start30 Sep 2021
- Primary completion31 May 2022
- Study completion4 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Burn Body Region UnspecifiedStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility study of randomized trial of enteral-based resuscitation (intervention arm) vs. IV fluid resuscitation (standard-of-care arm) for moderate sized burn injuries.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Kajal Mehta, MD MPH, University of Washington
- Investigators
- Kajal Mehta, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732624
- Sponsor's protocol ID
- STUDY00010934
- Other IDs
- D43TW009345
- Status last verified
- Oct 2023
- First submitted
- 20 Jan 2021
- Last updated
- 11 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Shrestha R, Mehta K, Dahanayake D, Yadav M, Nakarmi K, Bista P, Rai S, Pham T, Stewart BT. Feasibility of a randomized controlled trial of enteral vs intravenous resuscitation for adults with major burn injuries in Nepal. Burns. 2025 Mar;51(2):107347. doi: 10.1016/j.burns.2024.107347. Epub 2024 Dec 27.
PubMed 39798346Shrestha R, Mehta K, Mesic A, Dahanayake D, Yadav M, Rai S, Nakarmi K, Bista P, Pham T, Stewart BT. Barriers and facilitators to implementing enteral resuscitation for major burn injuries: Reflections from Nepalese care providers. Burns. 2025 Feb;51(1):107302. doi: 10.1016/j.burns.2024.107302. Epub 2024 Oct 28.
PubMed 39577105