Improving nutrition in critically ill patients with gastrointestinal issues
Achieving nuTritional Target in criticAlly Ill patieNts With iMpairEd gastroiNtesTinal Dysfunction
This study tests if combining two types of nutrition methods can help critically ill patients with gut issues get the right amount of food they need to recover.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Romanian Society for Enteral and Parenteral Nutrition Academic / other |
| Locations | 1 site (Bucharest) |
| Trial ID | NCT06510348 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of combining enteral and supplemental parenteral nutrition (SPN) to achieve nutritional targets in critically ill patients experiencing gastrointestinal dysfunction. It aims to address the challenges of providing adequate nutrition in patients who are mechanically ventilated and may have impaired absorption. The study will monitor the nutritional intake and uptake to ensure that patients receive the necessary calories and protein without the risks associated with overfeeding. By focusing on both the delivery and absorption of nutrients, the study seeks to improve patient outcomes in intensive care settings.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 who have been on mechanical ventilation for more than four days and have impaired intestinal absorption.
Not a fit: Patients who may not benefit include those with recent gastrointestinal surgery, severe malabsorption conditions, or other significant contraindications.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of complications and improve recovery times for critically ill patients.
How similar studies have performed: While some studies have explored nutritional support in critically ill patients, this specific combination of enteral and supplemental parenteral nutrition is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Bucharest
- Clinical Emergency Hospital of Bucharest — Bucharest, Romania (Recruiting)
Study contacts
- Principal investigator: Cristian Cobilinschi, MD, PhD — Bucharest Emergency Hospital
- Study coordinator: Cristian Cobilinschi, MD, PhD
- Email: cristian.cobilinschi@umfcd.ro
- Phone: +40765018776
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.