Clinical trial NCT04732624: Enteral Resuscitation Nepal (Pilot 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Burn Body Region Unspecified
Burn Shock
Keywords: Burns
Enteral Resuscitation
Oral Rehydration Solution
Burn Shock
Austere Conditions
Low- and middle-income country
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2021-02-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 24 Hour Average Urine Output (UOP)
timeFrame: 24 hours
measure: 24-hour Resuscitation Volume
timeFrame: 24 hours
measure: Hours From Injury to Resuscitation
timeFrame: Point measurement (Once at the start of resuscitation)
Secondary outcomes:
measure: Number of Participants With GI Discomfort
timeFrame: 24 hours
measure: Number of Participants Crossover to IV Due to GI Intolerance
timeFrame: 24hours
measure: Number of Participants With Acute Kidney Injury
timeFrame: 72 hours
measure: Participants Death Within 72 Hours of Resuscitation
timeFrame: 72 hours
measure: Discharge 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.
Other outcomes:
Locations:
city: Kirtipur
country: Nepal
facility: Nepal Cleft and Burn Center at Kirtipur Hospital
state: Bagmati
Study officials:
affiliation: University of Washington
name: Kajal Mehta, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: