UnknownNot Applicable

Effects of Enteral Nutrition on Stress Ulcer Hemorrage. Multicenter Randomized Controlled Trial

Turkey (Türkiye)500 participantsStarted 2016-08-01

Plain-language summary

Enteral nutrition can provides prophylaxis against stress ulcer bleeding in critically ill patients and there may be no need to use acid suppressing drugs for stress ulcer bleeding prophylaxis in these patients. Half of the patients on enteral nutrition will not receive any acid suppressing drugs while other half receives it. They will be followed for gastrointestinal bleeding.

Who can participate

Age range

18 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: * Age 18 years or older * Admission to ICU * Expected to stay in ICU \>24 hours * No contraindications to EN within the first 24 hours after admission to the intensive care unit Exclusion Criteria: * Evidence of active GI bleeding during current hospitalization prior to study entry * Coagulopathy (PLT\<50.000, INR\>1.5, aPTT\>2xcontrol) * Patients receiving acid suppressing drugs prior to admission * Pregnancy or lactation * History/documented gastric ulcer * Burn\>30% body surface area * Head injury or increased intracranial pressure * Partial or complete gastrectomy * Shock * Multi-system trauma * Exposure to gastric irritant drugs * Patients not giving informed consent

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

GI bleeding

Timeframe: Subjects will be followed from date of randomization until discharge from the ICU or cessation of enteral nutrition up to four weeks

Trial details

NCT IDNCT03098537

SponsorTC Erciyes University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08-01

Contact for this trial

Kurat Gundogan, MD

+90 352 207 6666 kgundogan@erciyes.edu.tr

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