Impact of the reduction of the recommended energy target in the ICU on protein delivery and clinical outcomes.
M M Berger, L Soguel, M Charrière...
https://pubmed.ncbi.nlm.nih.gov/26775753Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06510348
Achieving Nutritional Target in Critically Ill Patients With Impaired Gastrointestinal Dysfunction A Randomized Controlled Trial Comparing Enteral Nutrition Alone Versus Enteral Nutrition Plus Supplemental Parenteral Nutrition
Led by Romanian Society for Enteral and Parenteral Nutrition · Updated on 2024-11-06
164
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Romanian Society for Enteral and Parenteral Nutrition
Lead Sponsor
F
Fresenius Kabi
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying nutritional support strategies for critically ill patients with impaired gastrointestinal function, focusing on how to best achieve energy and protein intake goals. The study investigates the use of enteral nutrition alone versus a combination of enteral nutrition and supplemental parenteral nutrition (SPN) in patients who have impaired gastric emptying and reduced intestinal absorption. This research addresses the challenge of feeding intolerance and malnutrition in intensive care patients and explores muscle mass and function as important factors in nutrition efficacy. The study randomly assigns patients with diagnosed gastrointestinal dysfunction to one of two groups: one receiving gradual increases in enteral nutrition based on tolerance, and the other receiving a mix of enteral trophic feeding plus SPN to meet nutritional targets. Nutritional needs are monitored daily by indirect calorimetry, and gastrointestinal function is assessed with ultrasound gastric residual volume and a paracetamol absorption test. The SPN group aims to reach 80% of nutritional goals by day five, while the enteral nutrition group aims for full caloric intake as tolerated. Participants are monitored through various evaluations including muscle thickness via ultrasound, lean body mass by bioelectrical impedance analysis, and muscle strength with a handgrip dynamometer at admission and on days 10 and 15. The study measures daily calorie and protein intake adequacy, metabolic markers, and clinical outcomes such as mortality up to 28 days. Nutritional status, muscle function, and energy utilization are carefully assessed throughout the study to understand the impact of the tailored feeding protocols.
CONDITIONS
Brief Title
Achieving nuTritional Target in criticAlly Ill patieNts With iMpairEd gastroiNtesTinal Dysfunction
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults over 18 years old
- Expected to require mechanical ventilation for more than four days
- Controlled shock state with stable hemodynamic and tissue perfusion goals
- Diagnosed impaired intestinal absorption confirmed by ultrasound measurement of gastric residual volume and paracetamol absorption test
You will not qualify if you...
- Patients on non-invasive mechanical ventilation
- Contraindication for enteral nutrition for more than 48 hours after admission
- Gastrointestinal surgical intervention within the past 3 months
- History of malabsorption or inflammatory bowel disease
- Short bowel syndrome
- Anorexia nervosa
- Gastrointestinal bleeding
- Cirrhosis
- Traumatic brain injury
- Subarachnoid hemorrhage
- Neoplasia
- Post cardiac arrest patients
- Chronic therapy with corticosteroids
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - 4 days
Participants receive daily indirect calorimetry to evaluate energy requirements starting from ICU admission and begin enteral nutrition after 48 hours or once shock state is controlled, gradually increasing feeding to reach 75% of energy targets by day 4.
Daily assessments and nutritional adjustments
Treatment
Duration - Up to 11 days
Participants with impaired gastrointestinal function are randomized to either progressively increase enteral nutrition to 100% tolerance or to receive supplemental parenteral nutrition to reach 80% of target nutrition plus trophic enteral feeding covering 20%.
Daily nutritional support and monitoring visits
Follow-up
Duration - Up to 13 days
Participants undergo assessments including muscle thickness, bioelectrical impedance analysis, and muscle force measurements to evaluate nutritional impact up to day 15, with mortality and other clinical outcomes assessed through day 28.
Assessments on days 10, 15, and 28
Trial Site Locations
Total: 1 location
1
Clinical Emergency Hospital of Bucharest
Bucharest, Romania
Actively Recruiting
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Research Team
C
Cristian Cobilinschi, MD, PhD
L
Liliana Mirea, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Gastrointestinal dysfunction relating to the provision of nutrition in the critically ill.
Marianne J Chapman, Adam M Deane
https://pubmed.ncbi.nlm.nih.gov/25603226Supplemental parenteral nutrition improves immunity with unchanged carbohydrate and protein metabolism in critically ill patients: The SPN2 randomized tracer study.
Mette M Berger, Olivier Pantet, Nathalie Jacquelin-Ravel...
https://pubmed.ncbi.nlm.nih.gov/30448193Clinical nutrition issues in 2022: What is missing to trust supplemental parenteral nutrition (SPN) in ICU patients?
Mette M Berger, Rosa Burgos, Michael P Casaer...
https://pubmed.ncbi.nlm.nih.gov/36088342Peripheral muscular ultrasound as outcome assessment tool in critically ill patients on mechanical ventilation: An observational cohort study.
Diogo Oliveira Toledo, Branca Jardini de Freitas, Rogério Dib...
https://pubmed.ncbi.nlm.nih.gov/34024548Bioelectric impedance analysis for body composition measurement and other potential clinical applications in critical illness.
Hanneke Pierre Franciscus Xaverius Moonen, Arthur Raymond Hubert Van Zanten
https://pubmed.ncbi.nlm.nih.gov/33967207Gastrointestinal dysfunction in the critically ill: a systematic scoping review and research agenda proposed by the Section of Metabolism, Endocrinology and Nutrition of the European Society of Intensive Care Medicine.
Annika Reintam Blaser, Jean-Charles Preiser, Sonja Fruhwald...
https://pubmed.ncbi.nlm.nih.gov/32414423