Trial Outcomes & Findings for Enteral Resuscitation Nepal (Pilot Study) (NCT NCT04732624)
NCT ID: NCT04732624
Last Updated: 2023-10-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
24 hours
Results posted on
2023-10-11
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Enteral-based Protocolized Resuscitation
n=15 Participants
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
|
Intravenous Fluid Protocolized Resuscitation
n=15 Participants
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
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=15 Participants
|
12 Participants
n=15 Participants
|
23 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=15 Participants
|
3 Participants
n=15 Participants
|
7 Participants
n=30 Participants
|
|
Age, Continuous
|
48 years
n=15 Participants
|
50 years
n=15 Participants
|
49 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=15 Participants
|
11 Participants
n=15 Participants
|
22 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=15 Participants
|
4 Participants
n=15 Participants
|
8 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Nepal
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
30 participants
n=30 Participants
|
|
Total Body Surface Area (TBSA) with Burn Injury
|
25 percentage of burned surface area
n=15 Participants
|
30 percentage of burned surface area
n=15 Participants
|
30 percentage of burned surface area
n=30 Participants
|
PRIMARY outcome
Timeframe: 24 hoursCalculated 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.
Outcome measures
| Measure |
Enteral-based Protocolized Resuscitation
n=15 Participants
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
|
Intravenous Fluid Protocolized Resuscitation
n=15 Participants
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
|
|---|---|---|
|
24 Hour Average Urine Output (UOP)
|
0.7 ml/kg/hr
Interval 0.6 to 0.9
|
1 ml/kg/hr
Interval 0.7 to 1.2
|
PRIMARY outcome
Timeframe: 24 hoursCalculated 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)
Outcome measures
| Measure |
Enteral-based Protocolized Resuscitation
n=15 Participants
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
|
Intravenous Fluid Protocolized Resuscitation
n=15 Participants
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
|
|---|---|---|
|
24-hour Resuscitation Volume
|
6.7 ml/kg/% of TBSA burned
Interval 5.4 to 9.9
|
4.1 ml/kg/% of TBSA burned
Interval 3.6 to 5.7
|
PRIMARY outcome
Timeframe: Point measurement (Once at the start of resuscitation)Hours calculated from point of injury to starting of resuscitation.
Outcome measures
| Measure |
Enteral-based Protocolized Resuscitation
n=15 Participants
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
|
Intravenous Fluid Protocolized Resuscitation
n=15 Participants
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
|
|---|---|---|
|
Hours From Injury to Resuscitation
|
8.5 hours
Interval 4.3 to 12.5
|
13.5 hours
Interval 13.0 to 15.5
|
SECONDARY outcome
Timeframe: 24 hoursAny "check" for nausea, vomiting, distention, diarrhea
Outcome measures
| Measure |
Enteral-based Protocolized Resuscitation
n=15 Participants
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
|
Intravenous Fluid Protocolized Resuscitation
n=15 Participants
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
|
|---|---|---|
|
Number of Participants With GI Discomfort
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 24hoursPopulation: Not applicable to IV resuscitation arm as already on the standard of care arm
Number of participants crossover to standard of care (IV resuscitation) due to GI intolerance like nausea, vomitting
Outcome measures
| Measure |
Enteral-based Protocolized Resuscitation
n=15 Participants
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
|
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
|
|---|---|---|
|
Number of Participants Crossover to IV Due to GI Intolerance
|
9 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 72 hoursMeasured 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.
Outcome measures
| Measure |
Enteral-based Protocolized Resuscitation
n=15 Participants
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
|
Intravenous Fluid Protocolized Resuscitation
n=15 Participants
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
|
|---|---|---|
|
Number of Participants With Acute Kidney Injury
On Admission
|
4 Participants
|
2 Participants
|
|
Number of Participants With Acute Kidney Injury
At 72 hours
|
4 Participants
|
0 Participants
|
|
Number of Participants With Acute Kidney Injury
Renal Failure within 72 hours
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 72 hoursSecondary 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.
Outcome measures
| Measure |
Enteral-based Protocolized Resuscitation
n=15 Participants
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
|
Intravenous Fluid Protocolized Resuscitation
n=15 Participants
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
|
|---|---|---|
|
Participants Death Within 72 Hours of Resuscitation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured over complete course of hospitalization until discharge or death, assessed every 24 hours after enrollment in the study. Maximum timeframe 6 months.Outcome of hospital stay
Outcome measures
| Measure |
Enteral-based Protocolized Resuscitation
n=15 Participants
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
|
Intravenous Fluid Protocolized Resuscitation
n=15 Participants
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
|
|---|---|---|
|
Discharge Outcome
Discharged home
|
6 Participants
|
5 Participants
|
|
Discharge Outcome
Left against medical advice
|
3 Participants
|
6 Participants
|
|
Discharge Outcome
Death
|
6 Participants
|
4 Participants
|
Adverse Events
Enteral-based Protocolized Resuscitation
Serious events: 0 serious events
Other events: 8 other events
Deaths: 6 deaths
Intravenous Fluid Protocolized Resuscitation
Serious events: 0 serious events
Other events: 5 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Enteral-based Protocolized Resuscitation
n=15 participants at risk
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
|
Intravenous Fluid Protocolized Resuscitation
n=15 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
GI discomfort during resuscitation
|
53.3%
8/15 • 72 hours
|
33.3%
5/15 • 72 hours
|
Additional Information
Dr. Raslina Shrestha
University of Washington/Nepal cleft and burn center
Phone: +977 9849978888
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place