Enteral Resuscitation Nepal (Pilot Study)

NCT ID: NCT04732624

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2022-06-04

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enteral-based Protocolized Resuscitation

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.

Group Type: EXPERIMENTAL

Oral Rehydration Solution

Intervention Type: 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

Lactated Ringer

Intervention Type: DRUG

Standard-of-care Intravenous Fluid resuscitation

Intravenous Fluid Protocolized Resuscitation

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).

Group Type: ACTIVE_COMPARATOR

Lactated Ringer

Intervention Type: DRUG

Standard-of-care Intravenous Fluid resuscitation

Interventions

Oral Rehydration Solution

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

Intervention Type: DRUG

Lactated Ringer

Standard-of-care Intravenous Fluid resuscitation

Intervention Type: DRUG

Other Intervention Names

Enteral-based Resuscitation; Intravenous Fluid Resuscitation

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Kajal Mehta, MD MPH

Global Health Research Fellow, School of Medicine: Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kajal Mehta, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Nepal Cleft and Burn Center at Kirtipur Hospital

Ki̇̄rtipur, Bagmati, Nepal

Countries

Nepal

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

D43TW009345

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00010934

Identifier Type: -

Identifier Source: org_study_id