Enteral Resuscitation Nepal

• ClinicalTrials.gov Identifier: NCT04732624
• Recruitment Status: Recruiting
• First Posted: February 1, 2021
• Last Update Posted: December 30, 2021
• Sponsor: University of Washington
• Information provided by (Responsible Party): Kajal Mehta, MD MPH, University of Washington

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Burn Body Region Unspecified; Burn Shock	Drug: Oral Rehydration Solution; Drug: Lactated Ringer	Early Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Feasibility study of randomized trial of enteral-based resuscitation (intervention arm) vs. IV fluid resuscitation (standard-of-care arm) for moderate sized burn injuries.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Implementation of an Enteral Resuscitation Bundle for Moderate-sized Burn Injuries (20-40% Total Body Surface Area) to Prevent Shock, Coagulopathy, and Kidney and Lung Injury in Nepal
• Actual Study Start Date: September 30, 2021
• Estimated Primary Completion Date: April 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: 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; Other Name: Enteral-based Resuscitation; Drug: Lactated Ringer; Standard-of-care Intravenous Fluid resuscitation; Other Name: Intravenous Fluid Resuscitation
Active Comparator: 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).	Drug: Lactated Ringer; Standard-of-care Intravenous Fluid resuscitation; Other Name: Intravenous Fluid Resuscitation

Outcome Measures

Primary Outcome Measures :

1. Frequency of protocol adherence for recommended fluid adjustments [ Time Frame: 4 months ]

   Measured frequency of adherence to the recommend fluid adjustments for both enteral-based resuscitation and IV fluid resuscitation protocols by measuring completion rate of appropriate fluid rate adjustments made, as documented in the Documentation Chart for each patient.

   The Documentation Chart will be analyzed for correct ("appropriate") adjustment at each time check interval (every 2 hours) during the resuscitation period, as demonstrated by fluid adjustment documentation on the Documentation Chart. The assessment will be reported as the proportion of "'appropriate" fluid adjustments out of total fluid adjustments, for each patient in the IV fluid resuscitation arm and each patient in the Enteral-based resuscitation arm.

2. Frequency of protocol adherence for documentation [ Time Frame: 4 months ]
   Measured frequency of adherence to both enteral-based resuscitation and IV fluid resuscitation protocols by measuring completeness of documentation based on the proportion of rows filled out on the Documentation Chart during the acute resuscitation time period. This assessment will be reported as a proportion (percentage), and with a range from 0-100 percent, for each patient in the IV fluid resuscitation intervention arm and each patient in the Enteral-based resuscitation intervention arm.
3. Frequency of protocol adherence for laboratory assessments [ Time Frame: 4 months ]
   Measured frequency of adherence to both enteral-based resuscitation and IV fluid resuscitation protocols by measuring completion rate of the recommended 8-hourly laboratory assessments as documented on the laboratory section of the Documentation Chart. The completeness will be measured based on the proportion of rows filled out in the laboratory section of the Documentation Chart during the acute resuscitation time period. This assessment will be reported as a proportion (percentage), and with a range from 0-100 percent, for each patient in the IV fluid resuscitation intervention arm and each patient in the enteral-based resuscitation intervention arm.
4. Challenges and facilitators to enteral-based resuscitation and IV fluid resuscitation protocols [ Time Frame: 4 months ]

   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.

Secondary Outcome Measures :

1. Frequency of successful resuscitation [ Time Frame: 4 months ]

   Measure 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Kajal Mehta, MD; +1-979-824-5064; kajalm@uw.edu

Locations

Nepal

Nepal Cleft and Burn Center at Kirtipur Hospital; Recruiting

Kirtipur, Bagmati, Nepal

Contact: Shankar M Rai, MBBS +977 984-1295062 shankarrai1956@gmail.com

Sponsors and Collaborators

University of Washington

Investigators

• Principal Investigator: Kajal Mehta, MD; University of Washington

More Information

• Responsible Party: Kajal Mehta, MD MPH, Resident Physician, Global Health Research Fellow, School of Medicine: Surgery, University of Washington
• ClinicalTrials.gov Identifier: NCT04732624
• Other Study ID Numbers: STUDY00010934
• First Posted: February 1, 2021
• Last Update Posted: December 30, 2021
• Last Verified: December 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Kajal Mehta, MD MPH, University of Washington:

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

Additional relevant MeSH terms:

Shock; Burns; Pathologic Processes; Wounds and Injuries