Enteral Resuscitation Nepal (Pilot Study)
Condition: Burn Body Region Unspecified; Burn Shock
MeSH terms: Shock; Burns
Intervention: Oral Rehydration Solution; Lactated Ringer
Intervention description: 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; Standard-of-care Intravenous Fluid resuscitation
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Burns; Enteral Resuscitation; Oral Rehydration Solution; Burn Shock; Austere Conditions; Low- and middle-income country

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.