Clinical trial NCT05559489: Enteral Resuscitation Nepal
Official title: Implementation of an Enteral Resuscitation Bundle for the Moderate-sized Burn at Kirtipur Hospital, Nepal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Burn Body Region Unspecified
Burn Shock
Keywords: Burns
Enteral Resuscitation
Oral Rehydration Solution
Burn Shock
Austere condition
Low and middle income countries
Lead sponsor: Nepal Health Research Council
Sponsor class: OTHER_GOV
First posted: 2022-09-29
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: hybrid type 1 effectiveness-implementation study of a 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 associated high morbidity and mortality. Nepal currently has one major center equipped for comprehensive burn care, in Kirtipur, Nepal, and receives patients who are referred from around the country. At the time of presentation, most patients with major burns have had minimal to no resuscitation on arrival, and often present hours to days after the burn injury was sustained. Timely fluid resuscitation, initiated as soon as possible after a 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. However, in low- and middle-income countries such as Nepal, adequately trained and equipped hospitals for the treatment of burn care are not widely available (for a variety of reasons). Additionally, there is no systematic emergency medical transport system available to provide medical care and resuscitation during transport. Enteral-based resuscitation-drinking or administering fluids via the gastrointestinal tract-with substances like the WHO Oral Rehydration Solution (ORS) is recommended by burn experts and professional burn societies when resources and access to intravenous fluid resuscitation are not available. 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 resource-constrained settings. Therefore, the investigators seek to ultimately address the problem of pre-hospital and pre-burn center admission resuscitation by studying the effectiveness of enteral resuscitation with Oral Rehydration Solution (ORS) in preventing burn shock. A recent feasibility and pilot study(n=30) of this Enteral-based implementation bundle (EResus) i.e., training resources, protocol, and toolkit were conducted. The pilot study allowed for protocol development and testing, established the feasibility, provided key insights into implementation and helped develop infrastructure and study standard operating procedures at the study site. With the current study, the investigators aim to expand the trial to a full effectiveness-implementation trial, which will allow to further hone the EResus protocol and bundle, generate more effective implementation strategies, and obtain a clearer understanding of efficacy and frequency of specific outcomes.

This study examines enteral-based resuscitation (i.e. enteral with/without IV Fluids) versus enhanced standard of care 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 15-40% total body surface area (TBSA) to an enteral-based resuscitation versus the standard of care IV fluid resuscitation. The intervention will continue through the acute resuscitation period.

The primary study variables will include measures of urine output, vital signs, planned and administered resuscitation volumes, and routes of resuscitation along with frequency, timing, and treatment of any gastrointestinal symptomology, and serious adverse events such as kidney injury and aspiration events

Further, there will be a qualitative component to the study with focus group discussions of the bedside healthcare providers (doctors and nurses) caring for the enrolled patients, in order to understand the challenges and facilitators of enteral resuscitation. In-depth interviews will be conducted with enrolled patients and their families to further understand the patient perception, experience and challenges and facilitators. Qualitative analysis will be done to understand the major themes of challenges and facilitators to enteral resuscitation.


Eligibility criteria: Inclusion Criteria:

* Patients who present with moderate-sized burn injuries \[15- 40% total body surface areas (TBSA)\] to the Nepal Cleft and Burn Center within 24 hours of injury.
* All gender

Exclusion Criteria:

* Breastfeeding patients
* Patients with electrical burns, chemical burns, and suspected severe inhalation injuries.
* Patients in overt shock (defined as serum lactate \>2.5, or hypotension and altered mental status).
* Pregnant patients
* Patients with oropharyngeal defects and/or previously known diagnoses leading to a high risk of aspiration, and/or precluding safe nasal-enteric access will be excluded.
* Patients and/or family members who are unable to understand and provide informed consent for data abstraction or the interview will be excluded.

Primary outcomes:
measure: Effectiveness of enteral-based resuscitation
timeFrame: 2 years
measure: Challenges and facilitators to enteral-based resuscitation and IV fluid resuscitation protocols
timeFrame: 2 years
Secondary outcomes:
measure: Frequency of protocol adherence for recommended fluid adjustments
timeFrame: 2 years
measure: Frequency of protocol adherence for documentation
timeFrame: 2 years
measure: Frequency of protocol adherence for laboratory assessments
timeFrame: 2 years
Other outcomes:
Locations:
city: Kirtipur
country: Nepal
facility: Nepal Cleft and Burn Center, Kirtipur Hospital
state: Bagmati
Study officials:
affiliation: Nepal Cleft and Burn Center,Kirtipur Hospital
name: Kiran K Nakarmi, MBBS,MCh
role: PRINCIPAL_INVESTIGATOR
References: