Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202207838635151 Date of Approval: 05/07/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Enteral Resuscitation (4F EnteroResus) for Moderate-Size Burn Injuries ( 10 – 60% TBSA): A Hybrid Type I Effectiveness-Implementation Cluster Randomized Trial.
Official scientific title Enteral Resuscitation (4F EnteroResus) for Moderate-Size Burn Injuries ( 10 – 60% TBSA): A Hybrid Type I Effectiveness-Implementation Cluster Randomized Trial.
Brief summary describing the background and objectives of the trial Evaluate the effectiveness of enteral resuscitation in austere settings (primary goal); and Evaluate uptake of enteral resuscitation in austere environments and generate more effective implementation strategies (secondary goal).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) 4F EnteroResus
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Entero intervention
Anticipated trial start date 10/10/2021
Actual trial start date
Anticipated date of last follow up 10/10/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Enteral resuscitation Parkland Formula Calculations (for burn resuscitation fluid rate per hour) Target Urine Output (between 0.5 – 1.0 mL/kg/hr) 72 hours Our proposed intervention is an enteral resuscitation bundle. Enteral resuscitation relies on World Health Organization (WHO) Oral Rehydration Salts/Solution (ORS), supplied in small sachets of specific ratios of glucose and electrolytes that can be reconstituted with water. The volume to be provided will be estimated per the Parkland formula and hourly follow up of patients will be their hourly urine output. Hospitals randomised into this group will receive training workshop, reference videos, burn bag, worksheets and protocols, and communication strategy that ensures continuous support from the study team 120
Control Group Enhanced standard of care Estimated with Parkland formula 72 hours The control group will consent to an enhanced standard of care (IV resuscitation). District and regional hospitals in Ghana are sometimes staffed by providers who have limited trauma and burn care training. To create a control group most applicable for producing generalizable findings, we will enhance the standard of care in control hospitals to ensure that best possible care is being provided. The enhanced standard of care control bundle will still include the training workshop, reference videos, burn bag, worksheets and protocols, and communication strategy. However, the resuscitation supplies and protocol will recommend IV resuscitation instead of enteral resuscitation. NOTE: All burn patients, regardless if they are in the study get IVs placed, urinary catheters and NG tubes for feeding. 120 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with burn size from 10-60% TBSA • Flame, flash, scald or contact burn injury mechanism • Patients of all ages arriving to a participating hospital within 12 hours of injury Clinicians at participating hospitals who were part of the study training • Burn size smaller than 10% TBSA or larger than 60% • Patients arriving more than 12 hours from injury at participating hospital • Electrical burn injury mechanism • Chemical burn injury mechanism • Patients who are pregnant or lactating • Patients with polytrauma injuries • Patients with abnormal gastrointestinal anatomy or pathology such as oesophageal or gastric cancer • Patients with severe or symptomatic reflux 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 1 Day(s) 200 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/11/2021 COMMITTEE ON HUMAN RESEARCH PUBLICATIONS AND ETHICS KWAME NKRUMAH UNIVERSITY OF SCIENCE AND TECHNOLOGY SCHOOL OF MEDICAL SCIENCES and KOMFO ANOKYE TEACHING HOSPITAL
Ethics Committee Address
Street address City Postal code Country
Accra Rd KUMASI AK-039-50 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be average urine output (UOP) in milliliters (mL) per kilogram (kg) per hour (hr) during the first 24-hours after presentation to the hospital (Table 2). This will be used to create a dichotomous variable – successful or unsuccessful resuscitation. Given that under-resuscitation and over-resuscitation are both problematic, we will consider UOP less than 0.5mL/kg/hr and greater than 1mL/kg/hr to be unsuccessful. UOP between 0.5 and 1mL/kg/hr will be considered successful.(14) Differences in under- and over-resuscitation between the two arms will also be evaluated. hourly
Secondary Outcome Secondary outcomes will include those that occur during the resuscitation phase of burn injury and those during the remainder of the hospitalization (Table 2). Given that delay in resuscitation is a primary cause of poor outcomes after moderate burn injury, we will measure time to initiation of resuscitation. District and regional hospital providers may not have access to certain laboratory tests (e.g., chemistry, blood gas analysis) and or advanced diagnostics (e.g., ultrasound, X-ray). Therefore, our outcome measures do not rely on these testing resources. As examples, we will use simple measurements of volume status (e.g., urine output), the field definition of shock (i.e., altered mental status and weak/absent radial pulse), a clinical case definition for acute kidney injury (i.e., Kidney Disease Improving Global Outcomes (KDIGO) definition], and WHO clinical case definitions for lung injury, pneumonia, and sepsis. hourly
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
COMMITTEE ON HUMAN RESEARCH PUBLICATIONS AND ETHICS KNUST Accra Rd KUMASI Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
US Department of Defence 820 Chandler Street Fort Detrick MD 21702 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Defense Gerberding Hall G80 Box 351202 Seattle, WA 98195 US United States of America University
COLLABORATORS
Name Street address City Postal code Country
Barclay Stewart Department of Surgery, University of Washington Seattle 98195 United States of America
Kwesi Nsaful Department of Surgery, 37 Military Hospital Accra 0000 Ghana
Ighowho Etuh Department of Surgery, Tamale Teaching Hospital Tamale 0000 Ghana
Paa Ekow Hoyte Williams Department of Surgery, Komfo Anokye Teaching Hospital Kumasi 0000 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ADAM GYEDU drgyedu@gmail.com 0248228838 Accra Rd
City Postal code Country Position/Affiliation
KUMASI Ghana KATH
Role Name Email Phone Street address
Public Enquiries Mohammed Abdullah munhaminna1@gmail.com 0267070247 airport rd
City Postal code Country Position/Affiliation
kumasi AS-714-37 Ghana KNUST
Role Name Email Phone Street address
Scientific Enquiries Adam Gyedu drgyedu@gmail.com 0248228838 bekwai rd
City Postal code Country Position/Affiliation
kumasi Ghana KATH
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We intend to provide summary results of our study Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol We plan to share the additional documents 3 years after the study for a period of 5 years Deidentified data will be made available on reasonable request to Dr. Gyedu (drgyedu@gmail.com) pending approval from Kwame Nkrumah University of Science and Technology and University of Washington
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information