What is this study trying to find out about nutritional support in critically ill patients?

This study is evaluating how to best achieve energy and protein intake in critically ill patients with impaired gastrointestinal function. Researchers aim to compare enteral nutrition alone versus combined enteral and supplemental parenteral nutrition. The goal is to improve nutritional delivery and muscle function, sponsored by the Romanian Society for Enteral and Parenteral Nutrition.

Who may be eligible for this critical illness clinical trial?

Adults 18 years and older who require mechanical ventilation expected to last more than four days, have controlled shock state, and show impaired intestinal absorption may be eligible. Both men and women can participate, but people with recent gastrointestinal surgery or certain medical conditions are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this critical illness clinical trial?

Study-related care, including the study nutrition protocol and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect all necessary treatments and assessments to be included without charge.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06510348

Nutritional Support Strategies for Critically Ill Adults with Impaired Gastrointestinal Function Comparing Enteral Nutrition Alone Versus Enteral Plus Supplemental Parenteral Nutrition

Led by Romanian Society for Enteral and Parenteral Nutrition · Updated on 2024-11-06

164

Participants Needed

Research Sites

N/A

Total Duration

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

Research Team

Cristian Cobilinschi, MD, PhD

Liliana Mirea, MD, PhD

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