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ICU ulcer prevention drug under scrutiny: does pantoprazole help or harm?

NCT ID NCT02467621

Disease control Sponsor: Dr. Morten Hylander Møller Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving pantoprazole (a stomach acid reducer) to critically ill ICU patients prevents stress ulcers and reduces death. Over 3,300 adults at high risk were randomly assigned to receive pantoprazole or a placebo daily while in the ICU. Researchers tracked deaths, bleeding, pneumonia, and other complications to weigh benefits and risks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pantoprazole (a proton pump inhibitor, given intravenously)
What this could lead to
If successful, this could confirm that pantoprazole safely prevents stress ulcers in ICU patients without increasing serious side effects.
What could go wrong
This is a completed Phase 4 trial, but the results may not apply to all ICU patients. Potential harms like pneumonia or infection were also tracked.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

3,350 people

The number who actually took part.

Started

Jan 2016

Finished

Jan 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA: * Acute admission to the ICU * Age ≥ 18 years * One or more of the following risk factors: * Shock (continuous infusion with vasopressors or inotropes, systolic blood pressure \< 90 mmHg, mean arterial blood pressure \< 70 mmHg or lactate \> 4 mmol/l) * Acute or chronic intermittent or continuous renal replacement therapy * Invasive mechanical ventilation which is expected to last \> 24 hours * Coagulopathy (platelets \< 50 x 109/l or international normalized ratio (INR) \> 1.5 or prothrombin time (PT) \> 20 seconds) documented within the last 24 hours * Ongoing treatment with anticoagulant drugs (prophylaxis doses excluded) * History of coagulopathy (platelets \< 50 x 109/l or INR \> 1.5 or PT \> 20 seconds) within 6 months prior to hospital admission * History of chronic liver disease (portal hypertension, cirrhosis proven by biopsy, computed tomography (CT) scan or ultrasound, history of variceal bleeding or hepatic encephalopathy in the past medical history) EXCLUSION CRITERIA: * Contraindications to PPI * Ongoing treatment with PPI and/or H2RA on a daily basis * GI bleeding of any origin during current hospital admission * Diagnosed with peptic ulcer during current hospital admission * Organ transplant during current hospital admission * Withdrawal from active therapy or brain death * Fertile woman with positive urine human chorionic gonadotropin (hCG) or plasma-hCG * Consent according to national regulations not obtainable

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Conditions

The condition(s) this trial relates to.

Clostridium infectious disease Gastrointestinal Hemorrhage pneumonia duodenal ulcer prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastrointestinal bleeding Stress ulcers

Contacts and locations

Locations

  • Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet

    Copenhagen, 2100, Denmark

  • Dept. of Intensive Care, Aalborg University Hospital

    Aalborg, 9000, Denmark

  • Dept. of Intensive Care, Akershus University Hospital

    Lørenskog, 1478, Norway

  • Dept. of Intensive Care, Basel University Hospital

    Basel, 4056, Switzerland

  • Dept. of Intensive Care, Bergen University Hospital

    Bergen, 5021, Norway

  • Dept. of Intensive Care, Bern University Hospital

    Bern, 3010, Switzerland

  • Dept. of Intensive Care, Bispebjerg Hospital

    Copenhagen, 2400, Denmark

  • Dept. of Intensive Care, Copenhagen University Hospital Herlev

    Herlev, 2730, Denmark

  • Dept. of Intensive Care, Heerlen Hospital

    Heerlen, 6419, Netherlands

  • Dept. of Intensive Care, Helsinki University Hospital

    Helsinki, 00120, Finland

  • Dept. of Intensive Care, Herning Hospital

    Herning, 7400, Denmark

  • Dept. of Intensive Care, Hillerød Hospital

    Hillerød, 3400, Denmark

  • Dept. of Intensive Care, Hjørring Hospital

    Hjørring, 9800, Denmark

  • Dept. of Intensive Care, Holbæk Hospital

    Holbæk, 4300, Denmark

  • Dept. of Intensive Care, Holstebro Hospital

    Holstebro, 7500, Denmark

  • Dept. of Intensive Care, Kuopio University Hospital

    Kuopio, 70029, Finland

  • Dept. of Intensive Care, Køge University Hospital

    Køge, 4600, Denmark

  • Dept. of Intensive Care, Nykøbing Falster Sygehus

    Nykøbing Falster, 4800, Denmark

  • Dept. of Intensive Care, Oslo University Hospital

    Oslo, 0450, Norway

  • Dept. of Intensive Care, Oulu University Hospital

    Oulu, 90210, Finland

  • Dept. of Intensive Care, Randers Hospital

    Randers, 8930, Denmark

  • Dept. of Intensive Care, Roskilde Hospital

    Roskilde, 4000, Denmark

  • Dept. of Intensive Care, Slagelse Hospital

    Slagelse, 4200, Denmark

  • Dept. of Intensive Care, Stavanger University Hospital

    Stavanger, 4011, Norway

  • Dept. of Intensive Care, Tampere University Hospital

    Tampere, 33520, Finland

  • Dept. of Intensive Care, Turku University Hospital

    Turku, 20521, Finland

  • Dept. of Intensive Care, University Hospital of Wales

    Cardiff, United Kingdom

  • Dept. of Intensive Care, University Medical Center Groningen

    Groningen, 9713, Netherlands

  • Dept. of Intensive Care, Vejle Hospital

    Vejle, 7100, Denmark

  • Dept. of Intensive Care, Viborg Hospital

    Viborg, 8800, Denmark

  • Dept. of Intensive Care, Århus University Hospital Nørrebrogade

    Aarhus, 8000, Denmark

  • Dept. of Intensive Care, Århus University Hospital Skejby

    Aarhus, 8000, Denmark

  • Dept. of Neurointensive Care, Copenhagen University Hospital Rigshospitalet

    Copenhagen, 2100, Denmark

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