Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04732624
Status:
COMPLETED
Last Update Posted:
2023-10-11
First Post:
2021-01-20
Brief Title:
Enteral Resuscitation Nepal Pilot Study
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| D43TW009345 | NIH | None | httpsreporternihgovquickSearchD43TW009345 |