Effect of Semi-elemental Enteral Nutrition on Gastrointestinal Tolerance in Patients With Traumatic Brain Injury.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTang-Du Hospital
About this trial
Study Objective This clinical trial primarily aims to investigate whether semi-elemental enteral nutrition (SEN) improves gastrointestinal tolerance in patients with severe traumatic brain injury (TBI) and to evaluate its impact on clinical outcomes. The safety profile of SEN will also be assessed.
Key Research Questions Does SEN reduce the incidence of acute gastrointestinal injury (AGI) in severe TBI patients?
Study Design
Participants will be randomized 1:1 into either:
Intervention group: Receives SEN initiated within 48 hours post-injury and continued for ≥7 days.
Control group: Receives standard enteral nutrition over the same period.
Eligibility criteria
Qualifiers
Aged 18-75 years;
Clinically diagnosed with closed traumatic brain injury;
Glasgow Coma Scale (GCS) score ≤ 8;
Ability to initiate enteral nutrition within 48 hours post-injury;
Disqualifiers
GCS=3 with bilateral fixed and dilated pupils;
Hemodynamic instability or respiratory failure: mean arterial pressure <70mmHg, PaO2/FiO2<150, PaCO2<30 mmHg or >45 mmHg, or lactate >5 mmol/l;
Contraindications to both nasogastric and nasojejunal tube placement, or inability to complete tube placement within 48 hours of onset;
Contraindications to enteral nutrition therapy or semi-recumbent positioning;
Trial design
Treatments tested in this trial
- Semi-elemental formula
- Standard formula
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tang-Du Hospital
Lead sponsor
Ankang Central Hospital
Collaborator
Qilu Hospital of Shandong University (Qingdao)
Collaborator
960th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Collaborator
904th Hospital of the Joint Logistics Support Force of the PLA
Collaborator
West China Hospital
Collaborator
Qianfoshan Hospital
Collaborator
The First Affiliated Hospital of Xinxiang Medical College
Collaborator
Hanzhong Central Hospital
Collaborator
The General Hospital of Western Theater Command
Collaborator
The General Hospital of Northern Theater Command
Collaborator
Tangshan Gongren Hospital
Collaborator
987th Hospital of the Chinese People's Liberation Army Joint Logistic Support Force
Collaborator
Source ClinicalTrials.gov