Status:
NOT_YET_RECRUITING
Diluted and Undiluted Enteral Nutrition
Lead Sponsor:
Medical University of Lublin
Collaborating Sponsors:
Nutricia Fundation
Catholic University of Lublin
Conditions:
Critical Illness
Surgery
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Adult patients after elective major abdominal surgeries who are planned to be admitted to the Intensive Care Unit (ICU) can be included in the trial. Each patient will be fed via the gastrointestinal...
Detailed Description
Approximately 50 % of the intensive care unit (ICU) population has feeding intolerance (FI), which includes nausea, vomiting, diarrhea, and others. Some studies suggest that FI can be alleviated in pa...
Eligibility Criteria
Inclusion
- Scheduled for major abdominal surgery requiring ICU admission
- Having access to the GI tract (gastric or jejunal)
- Planned to be fed enterally
Exclusion
- Patients unable to give informed consent
- After emergency surgeries
- Without access to the GI tract
- Individuals with contraindications to EN, such as short bowel syndrome, uncompensated shock, acidosis (pH \< 7.1; lactate \> 5 mmol/l), bleeding from the upper GI tract, obstruction, intestinal ischemia, abdominal compartment syndrome
- Patients with symptomatic gastro-esophageal reflux
- Expected ICU stay \< 3 days
- Pregnancy and lactation
Key Trial Info
Start Date :
January 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06516835
Start Date
January 2 2025
End Date
April 30 2027
Last Update
July 26 2024
Active Locations (5)
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1
Provincial Hospital in Gorzow Wielkopolski
Gorzów Wielkopolski, Poland, 66-400
2
Fifth Military Hospital
Krakow, Poland, 30-901
3
First Military Hospital
Lublin, Poland, 20-049
4
II Department of Anesthesia and Intensive Care, Medical University of Lublin
Lublin, Poland, 20-081