Enteral Resuscitation Nepal (Pilot Study)

NCT04732624 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: STUDY00010934D43TW009345
• Study Type: interventional
• Target: 30
• 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 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.

Conditions

Burn Body Region Unspecified; Burn Shock

Keywords

Burns; Enteral Resuscitation; Oral Rehydration Solution; Burn Shock; Austere Conditions; Low- and middle-income country

Outcome Measures

Primary Outcomes (3)

• 24 Hour Average Urine Output (UOP)

  Calculated by totaling all of the recorded urine output (adding up the columns labelled HR 1-2 UO, HR 3-4 UO, etc. until HR 23-24), then dividing by their weight in Kg (column labelled Admission weight) and dividing by 24 hours. The units of this measurement will be mL/kg/hr.

  24 hours

• 24-hour Resuscitation Volume

  Calculated by totaling the total resuscitative fluids administered in first 24 hours of resuscitation, divided by admission weight and % TBSA of burn injury. (cc/kg/% TBSA of burn injury)

  24 hours

• Hours From Injury to Resuscitation

  Hours calculated from point of injury to starting of resuscitation.

  Point measurement (Once at the start of resuscitation)

Secondary Outcomes (5)

• Number of Participants With GI Discomfort

  24 hours

• Number of Participants Crossover to IV Due to GI Intolerance

  24hours

• Number of Participants With Acute Kidney Injury

  72 hours

• Participants Death Within 72 Hours of Resuscitation

  72 hours

• Discharge Outcome

  Measured over complete course of hospitalization until discharge or death, assessed every 24 hours after enrollment in the study. Maximum timeframe 6 months.

Study Arms (2)

Enteral-based Protocolized Resuscitation

EXPERIMENTAL

Administration of Enteral-based Resuscitation using Oral Rehydration Solution (ORS) either by mouth of via naso-enteric access for moderate sized burn injuries (20-40% 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 (20-40% TBSA).

Drug: Lactated Ringer

Interventions

Oral Rehydration Solution DRUG

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

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: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Nepal Cleft and Burn Center at Kirtipur Hospital

Ki̇̄rtipur, Bagmati, Nepal

Location

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

Results Point of Contact

• Title: Dr. Raslina Shrestha
• Organization: University of Washington/Nepal cleft and burn center

raslinas@uw.edu

+977 9849978888

Study Officials

• Kajal Mehta, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: Feasibility study of 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: January 20, 2021
• First Posted: February 1, 2021
• Study Start: September 30, 2021
• Primary Completion: May 31, 2022
• Study Completion: June 4, 2022
• Last Updated: October 11, 2023
• Results First Posted: October 11, 2023

Record last verified: 2023-10

Locations

NE (1)