Far-Forward, Fluid First, (4F) Enteral Resuscitation (EnteroResus) for Moderate-Size Burns (20 percent-40 percent TBSA): A Hybrid Type 1 Effectiveness-Implementation Study
Abstract
Short- and long-term outcomes of soldiers and civilians with burn injuries are greatly impacted by the care provided in the first hours and days after injury, particularly fluid resuscitation. (1-3) Profound inflammation-induced capillary leak syndrome (CLS) is a hallmark of moderate and severe burn injury. (4) If un-or under-treated, CLS results in dehydration, hypovolemic shock, wound progression, organ failure and death. Patients with burn injuries greater than or equal to 10-20 percent total body surface area (TBSA) are typically resuscitated with intravenous (IV) fluids to prevent these sequelae. However, in austere settings, patients often present to medics, health posts, and first-level hospitals that do not have the resources to provide goal-directed IV fluid resuscitation. (5) To address the complexity of goal-directed IV fluid resuscitation while acknowledging resource constraints in LMICs, burn care experts have recommended implementation of enteral resuscitation-based protocols. (6-11) burn injured soldiers and civilians around the world. We plan to perform a hybrid effectiveness implementation cluster-randomized controlled trial of enteral resuscitation to IV resuscitation in Ghana. The first year has been focused on developing materials (e.g., study protocol revisions, resuscitation protocols, documentation, educational/training materials, DSMB documents), navigating the labyrinth of US and Ghanaian regulatory bodies with conflicting priorities/perspectives (e.g., eligibility of children, safety of enteral resuscitation, role of IV fluids in the intervention clusters), establishing agreements and infrastructure to facilitate the project (e.g., sub-contracts, financial sharing platform), and bringing co-investigators and sites to speed on research operations. With these initial steps and processes in place, we will overcome the regulatory hurdles, onboard sites and begin enrollment within the coming year.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2022
- Accession Number
- AD1190957
Entities
People
- Barclay T. Stewart
Organizations
- University of Washington