Enteral Resuscitation (4F EnteroResus) for Moderate-Size Burn Injuries ( 10 – 60% TBSA): A Hybrid Type I Effectiveness-Implementation Cluster Randomized Trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202207838635151

Enrollment

240

Registered

2022-07-05

Start date

2021-10-10

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury, Occupational Diseases, Poisoning

Interventions

Enteral resuscitation

Enhanced standard of care

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Ghana

Contacts

Public ContactMohammed Abdullah

KNUST

munhaminna1@gmail.com0267070247

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026