Not Yet RecruitingNot Applicable

Diluted and Undiluted Enteral Nutrition

Poland60 participantsStarted 2025-01-02

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants having nausea and vomiting

Timeframe: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

Number of participants having diarrhea

Timeframe: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

Number of participants having increased gastric residual volume

Timeframe: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

Number of participants in whom target EN will not be achieved

Timeframe: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

Number of participants in whom prokinetic agents will be used

Timeframe: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

Trial details

NCT IDNCT06516835

SponsorMedical University of Lublin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-31

Contact for this trial

Michal Borys, MD, PhD

+48 506350569 michalborys1@gmail.com

View on ClinicalTrials.gov More Critical Illness trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants having nausea and vomiting

Timeframe: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

Number of participants having diarrhea

Timeframe: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

Number of participants having increased gastric residual volume

Timeframe: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

Number of participants in whom target EN will not be achieved

Timeframe: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first

Number of participants in whom prokinetic agents will be used

Timeframe: From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first