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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Semi-elemental formula
Dietary supplementTreatment: Semi-elemental enteral nutrition Objective: To assess the efficacy of semi-elemental enteral nutrition in enhancing gastrointestinal tolerance in patients with severe traumatic brain injury.
Standard formula
Dietary supplementTreatment: Standard enteral nutrition Objective: To serve as the control for evaluating the efficacy and safety of semi-elemental enteral nutrition versus standard nutritional therapy
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Gastrointestinal Intolerance
Proportion of patients developing gastrointestinal intolerance within 7 days of enteral nutrition initiation. (Composite endpoint including: vomiting, diarrhea, constipation, gastroparesis, gastrointestinal bleeding, and abdominal distension.)
Time frame
Within 7 days.Secondary outcomes
1
Hospitalization length of stay (LOS)
Total length of stay in the hospital.
Time frame
Periprocedural.2
NICU LOS
Total length of stay in the neurological intensive care unit (NICU)
Time frame
Periprocedural3
In-hospital mortality
Mortality rate in hospital.
Time frame
Periprocedural.4
ICU mortality
Mortality rate in NICU
Time frame
PeriproceduralSponsors and contacts
Click on the lead sponsor to view all of their trials.
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