Critical IllnessGastro Intestinal SurgeryEnteral Feeding IntoleranceGastro-Intestinal DisorderQuality of Lifte
Investigational drug(s) / intervention(s)
Enteral fluidIntravenous fluid
Enteral fluid: GNAK will be administered to the gastrointestinal tract with EN in the same volume.
Intravenous fluid: Undiluted EN will be given to the gastrointestinal tract. GNAK, in the same volume, will be administered intravenously.
Study summary
Adult patients after elective major abdominal surgeries who are planned to be admitted to the Intensive Care Unit (ICU) can be included in the trial. Each patient will be fed via the gastrointestinal tract. Half of the patients will receive enteral nutrition (EN) with additional fluids, and the rest will receive undiluted EN. The primary aim of this study is to assess feeding intolerance in both patient groups.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Adults, ≥18, Scheduled for major abdominal surgery requiring ICU admission Having access to the GI tract (gastric or jejunal) Planned to be fed enterally
Exclusion Criteria:
Patients unable to give informed consent After emergency surgeries Without access to the GI tract Individuals with contraindications to EN, such as short bowel syndrome, uncompensated shock, acidosis (pH \< 7.1; lactate \> 5 mmol/l), bleeding from the upper GI tract, obstruction, intestinal ischemia, abdominal compartment syndrome Patients with symptomatic gastro-esophageal reflux Expected ICU stay \< 3 days Pregnancy and lactation
Primary outcome measure(s)
Number of patients having vomiting. — From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first Any incidents of vomiting.
Number of participants who received prokinetic agents. — From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first Administration of prokinetic agents starting with both erythromycin (125mg twice daily enterally) and metoclopramide (10mg three times per day i.v.) due to significant EN intolerance, i.e. ≥ 2 incidents of vomiting/24h; \> 500 mL of gastric volume/6h; presence of gastric contents/nutrition in the endotracheal tube due to regurgitation
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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