Diluted and Undiluted Enteral Nutrition

Condition(s) studied

Investigational drug(s) / intervention(s)

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 feeding intolerance assessment in both groups of patients.

Eligibility

Primary outcome measure(s)

• Number of participants having nausea and vomiting — From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
  Incidents of nausea and vomiting (nausea measured with a 4-point verbal descriptive scale (0=no nausea, 1=mild, 2=moderate, 3=severe))
• Number of participants having diarrhea — From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
  Incidents of diarrhea (≥ three loose stools per day)
• Number of participants having increased gastric residual volume — From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
  Increased gastric residual volume (\> 500 ml of gastric aspirate/ 6 hours). Only in patients after lower GI tract surgeries (with intact stomach and gastric feeding)
• Number of participants in whom target EN will not be achieved — From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
  Achieving target EN on day three and later: 80% of protein requirements according to ESPEN (1.3/kg of ideal body weight (patients BMI \< 30) or adjusted body weight, BMI ≥ 30)
• Number of participants in whom prokinetic agents will be used — 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 according to the intensivist discretion. Starting with both erythromycin (125 mg twice daily enterally) and metoclopramide (10mg three times per day i.v.)

Trial sites (5)

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