Improving burn care with enteral resuscitation in Nepal
Implementation of an Enteral Resuscitation Bundle for the Moderate-sized Burn at Kirtipur Hospital, Nepal
PHASE3 · Nepal Health Research Council · NCT05559489
This study tests if giving fluids through drinking solutions helps people with moderate burns in Nepal recover better than the usual IV fluids.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | Nepal Health Research Council (other gov) |
| Locations | 1 site (Kirtipur, Bagmati) |
| Trial ID | NCT05559489 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of enteral resuscitation using oral rehydration solutions in patients with moderate-sized burn injuries in Nepal. The study aims to provide timely fluid resuscitation to patients who often arrive at the hospital with minimal prior treatment. By comparing enteral methods to the standard intravenous fluid resuscitation, the trial seeks to improve patient outcomes in a resource-limited setting. The focus is on patients presenting within 24 hours of their burn injury, addressing a critical gap in burn care in the region.
Who should consider this trial
Good fit: Ideal candidates are patients with moderate-sized burns (15-40% TBSA) who present to the Nepal Cleft and Burn Center within 24 hours of injury.
Not a fit: Patients with severe burns, electrical or chemical injuries, or those in overt shock will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce morbidity and mortality associated with burn injuries in low-resource settings.
How similar studies have performed: While the standard of care for burn resuscitation is intravenous, this enteral approach is novel and has not been widely tested in similar settings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kirtipur, Bagmati
- Nepal Cleft and Burn Center, Kirtipur Hospital — Kirtipur, Bagmati, Nepal (RECRUITING)
Study contacts
- Principal investigator: Kiran K Nakarmi, MBBS,MCh — Nepal Cleft and Burn Center,Kirtipur Hospital
- Study coordinator: Raslina Shrestha, MBBS
- Email: raslinas@uw.edu
- Phone: +977-984-997-8888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Burn Body Region Unspecified, Burn Shock, Burns, Enteral Resuscitation, Oral Rehydration Solution, Austere condition, Low and middle income countries