Status:
RECRUITING
Achieving nuTritional Target in criticAlly Ill patieNts With iMpairEd gastroiNtesTinal Dysfunction
Lead Sponsor:
Romanian Society for Enteral and Parenteral Nutrition
Collaborating Sponsors:
Fresenius Kabi
Carol Davila University of Medicine and Pharmacy
Conditions:
Parenteral Nutrition
Gastroparesis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Clear study hypothesis / research question It has already been proven that a prolonged negative energy balance during intensive care stay is an independent risk factor for mortality. Although it was ...
Detailed Description
Rationale and clinical significance of the hypothesis It has already been stated that nutritional support represents a crucial component in the care of critically ill patients. High metabolic demand ...
Eligibility Criteria
Inclusion
- All adults (\> 18 years old)
- Mechanical ventilation for more than four days,
- Controlled shock state (hemodynamic and tissue perfusion goals are reached) - Impaired intestinal absorbtion, defiend by both ultrasound measurement of gastric residual volume and paracetamol absorbtion test
Exclusion
- patients on non-invasive mechanichal ventilation
- contraindication for EN for \> 48 h after admission
- patients with gastrointestinal surgical intervention within 3 months,
- history of malabsorption, inflammatory bowel disease
- short bowel syndrom
- anorexia nervosa
- gastrointestinal bleeding
- cirrhosis
- traumatic brain injury
- subarahnoidal hemorrhage
- neoplasia
- post cardiac arrest patients
- patients on chronic therapy with corticosteroids
- pregnant women.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT06510348
Start Date
October 1 2024
End Date
December 31 2026
Last Update
November 6 2024
Active Locations (1)
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1
Clinical Emergency Hospital of Bucharest
Bucharest, Romania