Achieving nuTritional Target in criticAlly Ill patieNts With iMpairEd gastroiNtesTinal Dysfunction
Key facts
- Who runs it
- Romanian Society for Enteral and Parenteral Nutrition
- Where
- Romania1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 164 people, planned
- Started
- 1 Oct 2024
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Supplemental Parenteral Nutrition (SPN)
- Record updated
- 6 November 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- patients with gastrointestinal surgical intervention within 3 months,
- patients on chronic therapy with corticosteroids
- history of malabsorption, inflammatory bowel disease
- gastrointestinal bleeding
- subarahnoidal hemorrhage
- post cardiac arrest patients
- patients on non-invasive mechanichal ventilation
- contraindication for EN for > 48 h after admission
- short bowel syndrom
- anorexia nervosa
- cirrhosis
- traumatic brain injury
- neoplasia
- pregnant women
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Clear study hypothesis / research question
Read full original descriptionShow less
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.
The 2 groups in the trial
- EN groupNo study treatment, for comparison
enteral nutrition intake will progressively be increased according to the gastrointestinal tolerance (evaluated based on ultrasound guided gastric residual volume measurement) until the target of 100% is attained following admission to the ICU.
- Supplemental parenteral nutrition (SPN) groupTreatment being tested
gradually initiate supplemental parenteral nutrition in order to achieve the target of 80% by the fifth day. Trophic feed will be administered to cover the remaining 20% of the targeted nutrition intake.
Treatment: Supplemental Parenteral Nutrition (SPN)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 6 November 2024