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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of Washington
Collaborator:
Fogarty International Center of the National Institute of Health