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| ID | Type | Description | Link |
|---|---|---|---|
| D43TW009345 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Rehydration Solution | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | 24 hours |
| Hours From Injury to Resuscitation | Hours calculated from point of injury to starting of resuscitation. | Point measurement (Once at the start of resuscitation) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With GI Discomfort | Any "check" for nausea, vomiting, distention, diarrhea | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kajal Mehta, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nepal Cleft and Burn Center at Kirtipur Hospital | Ki̇̄rtipur | Bagmati | Nepal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39798346 | Derived | 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. | |
| 39577105 | Derived | Shrestha 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enteral-based Protocolized Resuscitation | 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. Oral Rehydration Solution: 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 Ringer: Standard-of-care Intravenous Fluid resuscitation |
| FG001 | Intravenous Fluid Protocolized Resuscitation | 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). Lactated Ringer: Standard-of-care Intravenous Fluid resuscitation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enteral-based Protocolized Resuscitation | 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. Oral Rehydration Solution: 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 Ringer: Standard-of-care Intravenous Fluid resuscitation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | ml/kg/hr | 24 hours |
|
72 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enteral-based Protocolized Resuscitation | 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. Oral Rehydration Solution: 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 Ringer: Standard-of-care Intravenous Fluid resuscitation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI discomfort during resuscitation | Gastrointestinal disorders | Non-systematic Assessment | Check with any nausea, vomiting, distention, diarrhea during resuscitation period i.e. 24 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Raslina Shrestha | University of Washington/Nepal cleft and burn center | +977 9849978888 | raslinas@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 28, 2022 | Jul 17, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C044142 | World Health Organization oral rehydration solution |
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Feasibility study of randomized trial of enteral-based resuscitation (intervention arm) vs. IV fluid resuscitation (standard-of-care arm) for moderate sized burn injuries.
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|
| Lactated Ringer | Drug | Standard-of-care Intravenous Fluid resuscitation |
|
|
| 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. | 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. | 72 hours |
| Discharge Outcome | Outcome of hospital stay | Measured over complete course of hospitalization until discharge or death, assessed every 24 hours after enrollment in the study. Maximum timeframe 6 months. |
| BG001 | Intravenous Fluid Protocolized Resuscitation | 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). Lactated Ringer: Standard-of-care Intravenous Fluid resuscitation |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Total Body Surface Area (TBSA) with Burn Injury | Median | Inter-Quartile Range | percentage of burned surface area |
|
| OG001 | Intravenous Fluid Protocolized Resuscitation | 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). Lactated Ringer: Standard-of-care Intravenous Fluid resuscitation |
|
|
| Primary | 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) | Posted | Median | Inter-Quartile Range | ml/kg/% of TBSA burned | 24 hours |
|
|
|
| Primary | Hours From Injury to Resuscitation | Hours calculated from point of injury to starting of resuscitation. | Posted | Median | Inter-Quartile Range | hours | Point measurement (Once at the start of resuscitation) |
|
|
|
| Secondary | Number of Participants With GI Discomfort | Any "check" for nausea, vomiting, distention, diarrhea | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | 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 | Not applicable to IV resuscitation arm as already on the standard of care arm | Posted | Count of Participants | Participants | 24hours |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 72 hours |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 72 hours |
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| Secondary | Discharge Outcome | Outcome of hospital stay | Posted | Count of Participants | Participants | Measured over complete course of hospitalization until discharge or death, assessed every 24 hours after enrollment in the study. Maximum timeframe 6 months. |
|
|
|
| 6 |
| 15 |
| 0 |
| 15 |
| 8 |
| 15 |
| EG001 | Intravenous Fluid Protocolized Resuscitation | 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). Lactated Ringer: Standard-of-care Intravenous Fluid resuscitation | 4 | 15 | 0 | 15 | 5 | 15 |
|
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| D012216 |
| Rheumatic Diseases |
| Renal Failure within 72 hours |
|
| Death |
|