NCT06510348 Achieving nuTritional Target in criticAlly Ill patieNts With iMpairEd gastroiNtesTinal Dysfunction
| NCT ID | NCT06510348 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Romanian Society for Enteral and Parenteral Nutrition |
| Condition | Parenteral Nutrition |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 164 participants in total. It began in 2024-10-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 thought that achivieng optimal delivery of calories will prevent nutritional deficits in critically ill patients, published randomized controlled trials failed to confirm this hypothesis. Combinging enteral and parenteral support may be an efficent strategy to reach nutritional target in critically ill patients. According to the current guidelines the use of suplemental parenteral nutrition (SPN) should be considered when energy targets are not achieved by enteral (EN) route, however, no clear data regarding timing, amount and composition is specified. Moreover, based on recente published data overfeeding should also be avoided, considering the negative impact on outcome. Nutritional support for critically ill patients was focused more on preventing caloric and protein deficits and no great emphasis was placed on the efficiency of intestinal absorption. Gastrointestinal dysfunction is a prevalent reported complication that may contribute to falling short of meeting nutritional goals. This encompasses a wide spectrum of symptoms, such as impaired gastric emptying, ileus or impaired intestinal absorbtion, exposing patients to feeding intolerance, malnutrition and worse outcomes. No standard definition and monitoring techniques are so far available for the diagnostic of feeding intolerance. Although increased gastric residual volume (GRV) is the most used parameter for highlighting feeding intolerance, a controversy regarding the adequate threshold of GRV persists. Acetaminophen absorption test has been previously proposed as a diagnostic tool to asses impaired gastric emptying and intestinal absorbtion. Besides intestinal absorbtion, efficient utilization of macronutients should also be assessed, considering that critically ill patients have varying metabolic conditions and may not be able to metabolically handle adminsitered substrates. As a result body composition analysis should be taken into account in order to obtain a dynamic quantification, especially, of the mucle mass compartiments. Therefore the following low-interventional study is designed to investigate the hypothesis regarding energy and protein intake achievement in critically ill patients with diagnosed impaired gastrointestinal dysfunction to whom tailored nutritional support is administered. Taking into account that we aim to identify patients with early-phase gastrointestinal dysfunction impaired gastric emptying and reduced intestinal absorbtion (diagnosed using ultrasound gastric residual volume and byacetaminiphen absorbtion test) will serve as defining factors. Patients will be randomized to receive nutritional support either according to the EN protocol or enteral trophic feed + SPN protocol. Differences in rectus femoris thickness measured on admission, on day 10 and 15, variation of lean body mass measured by bioelectrical impedance on admission on day 10 and 15, and differences between groups in muscle function using handgrip dynamometer will also be evaluated in both groups.
Eligibility 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.
Contact & Investigator
Cristian Cobilinschi, MD, PhD
PRINCIPAL INVESTIGATOR
Bucharest Emergency Hospital
Frequently Asked Questions
Who can join the NCT06510348 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parenteral Nutrition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06510348 currently recruiting?
Yes, NCT06510348 is actively recruiting participants. Contact the research team at cristian.cobilinschi@umfcd.ro for enrollment information.
Where is the NCT06510348 trial being conducted?
This trial is being conducted at Bucharest, Romania.
Who is sponsoring the NCT06510348 clinical trial?
NCT06510348 is sponsored by Romanian Society for Enteral and Parenteral Nutrition. The principal investigator is Cristian Cobilinschi, MD, PhD at Bucharest Emergency Hospital. The trial plans to enroll 164 participants.