Enteral Resuscitation Nepal

NCT05559489 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: STUDY00010934-A
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Body Region Unspecified; Burn Shock

Keywords

Burns; Enteral Resuscitation; Oral Rehydration Solution; Burn Shock; Austere condition; Low and middle income countries

Outcome Measures

Primary Outcomes (2)

• Effectiveness of enteral-based resuscitation

  Measure the frequency of successful resuscitation for both enteral-based and IV fluid resuscitation protocols by measuring frequency of achieving goal average urine output of at least 0.5 mL/kg/hr per the resuscitation protocol for the overall 24 hour time period for each patient in the IV-fluid based and enteral-based resuscitation protocol arms as demonstrated on the Documentation Chart. This value will be calculated by taking the sum total of urine produced in milliliters during the resuscitation period (mL), divided by the patient's measured weight on admission in kilograms (kg), and further divided by the length of the resuscitation in hours (hr). The overall urine output in the resuscitation will be calculated for each patient. Based on the urine output and whether it achieved goal (0.5 mL/kg/hr) or not, each will be designated as "successful" or "unsuccessful". For each intervention arm, the proportion of patients with "successful" resuscitation will be calculated.

  2 years

• Challenges and facilitators to enteral-based resuscitation and IV fluid resuscitation protocols

  These are qualitative metrics of the challenges and facilitators of adherance to the IV fluid and enteral-based resuscitation protocols as described by the clinical bedside providers. These will be obtained from focus group interviews with the bedside burn care providers at the study site. The focus group interviews will occur prior to patient enrollment, halfway through patient enrollment and after the conclusion of patient enrollment. The focus group interviews will be audiorecorded, and then will undergo transcription and translated as needed for qualitative thematic analysis. A codebook will be developed and thematic analysis conducted to understand the qualitative frequency and relevancy of each cited "challenge" and "facilitator" for adhering to the resuscitation protocols. These qualitative measures will not be graded with a score, or on a scale.

  2 years

Secondary Outcomes (3)

• Frequency of protocol adherence for recommended fluid adjustments

  2 years

• Frequency of protocol adherence for documentation

  2 years

• Frequency of protocol adherence for laboratory assessments

  2 years

Study Arms (2)

Enteral-based Protocolized Resuscitation

EXPERIMENTAL

Administration of Enteral-based Resuscitation using Oral Rehydration Solution (ORS) either by mouth or via naso-enteric access for moderate sized burn injuries (15-40% TBSA) per resuscitation protocol for burn-injured patients. Resuscitation will be administered in the acute resuscitation phase of burn injury (24-72 hours post injury). Patients will receive supplemental Intravenous Fluid (IV Fluid) resuscitation using Lactated Ringer's solution as needed per protocol.

Drug: Oral Rehydration Solution; Drug: Lactated Ringer

Intravenous Fluid Protocolized Resuscitation

ACTIVE COMPARATOR

Administration of Intravenous Fluid using Lactated Ringer's solution per standard of care resuscitation protocol for patients with moderate sized burn injuries (15-40% TBSA).

Drug: Lactated Ringer

Interventions

Oral Rehydration Solution DRUG

Effectiveness- implementation study of Enteral-based resuscitation with Oral Rehydration Solution (ORS) vs standard-of-care Intravenous Fluid resuscitation for moderate-sized burn injuries in Nepal

Also known as: Enteral-based Resuscitation

Enteral-based Protocolized Resuscitation

Lactated Ringer DRUG

Standard-of-care Intravenous Fluid resuscitation

Also known as: Intravenous Fluid Resuscitation

Enteral-based Protocolized Resuscitation; Intravenous Fluid Protocolized Resuscitation

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nepal Health Research Council: lead

Study Sites (1)

Nepal Cleft and Burn Center, Kirtipur Hospital

Ki̇̄rtipur, Bagmati, Nepal

RECRUITING

MeSH Terms

Conditions

Burns; Osteoarthritis

Interventions

World Health Organization oral rehydration solution; Ringer's Lactate

Condition Hierarchy (Ancestors)

Wounds and Injuries; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Kiran K Nakarmi, MBBS,MCh

  Nepal Cleft and Burn Center,Kirtipur Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raslina Shrestha, MBBS

CONTACT

+977-984-997-8888; raslinas@uw.edu

Shankar M Rai, MBBS,MS,MS

CONTACT

+977-984-129-5062; shankarrai1956@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Global Health Research Fellow

Model Details: 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.

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 29, 2022
• Study Start: December 8, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

NE (1)