Stress Ulcer Prophylaxis in the Intensive Care Unit

Phase 4

Completed

• Conditions: Gastrointestinal Bleeding; Stress Ulcers
• Interventions: Other: Saline (0.9%); Drug: Pantoprazole

• Registration Number: NCT02467621
• Lead Sponsor: Dr. Morten Hylander Møller

Brief Summary

Stress ulcer prophylaxis (SUP) is standard of care in the intensive care unit (ICU), however the quantity and quality of evidence is low and potential harm has been reported.

The aim of the SUP-ICU trial is to asses the overall benefits and harms of SUP with proton pump inhibitor in adult critically ill patients in the ICU.

Detailed Description

Critically ill patients in the ICU are at risk of stress related gastrointestinal (GI) bleeding, and SUP is recommended. However, the quantity and quality of evidence supporting SUP is low and has been questioned. Furthermore studies have shown that proton pump inhibitors (PPIs) may increase the risk of pneumonia, clostridium difficile infection and acute myocardial ischemia. The aim of the SUP-ICU trial is to assess the benefits and harms of SUP with PPI in adult critically ill patients in the ICU.

Study Timeline

• Study First Submitted: 2015-06-05
• Study First Submitted QC: 2015-06-09
• Study First Posted: 2015-06-10
• Study Start: 2016-01
• Primary Completion: 2017-10-22
• Study Completion: 2018-01-21
• Results First Submitted: 2018-10-29
• Results First Submitted QC: 2019-03-05
• Results First Posted: 2019-06-07
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3350

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Saline (0.9%)	Saline (0.9%)
Proton pump inhibitor (PPI)	Pantoprazole	Pantoprazole 40 mg

Primary Outcome Measures

Name	Time	Method
Mortality	90 days	Landmark mortality 90-days after randomization

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Clinically Important GI Bleeding	Until ICU discharge, maximum 90 days	Number of participants with one or more episodes of clinically important GI bleeding in the ICU
Number of Serious Adverse Reactions	Until ICU discharge, maximum 90 days	Serious adverse reactions are: anaphylactic reactions, agranulocytosis, pancytopenia, acute hepatic failure, Steven Johnsons Syndrome and toxic epidermal necrolysis, interstitial nephritis and angioedema.
Percentage of Days Alive Without Organ Support	Within 90 days	Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia	Until ICU discharge, maximum 90 days	Composite outcome of the number of participants with one or more of the mentioned conditions in the ICU
Number of Participants With One or More Infectious Adverse Events	Until ICU discharge, maximum 90 days	Number of participants with one or more episodes of pneumonia or clostridium difficile infection in the ICU
Mortality	1 year	Data for landmark mortality 1 year after randomization.
A Health Economic Analysis	90 days	This has not been completed yet.

Trial Locations

Locations (33)

Dept. of Intensive Care, Århus University Hospital Skejby; 🇩🇰 Arhus, Denmark

Dept. of Intensive Care, Basel University Hospital; 🇨🇭 Basel, Switzerland

Dept. of Intensive Care, University Hospital of Wales; 🇬🇧 Cardiff, United Kingdom

Dept. of Intensive Care, Bern University Hospital; 🇨🇭 Bern, Switzerland

Dept. of Intensive Care, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Dept. of Intensive Care, Copenhagen University Hospital Herlev; 🇩🇰 Herlev, Denmark

Dept. of Intensive Care, Hillerød Hospital; 🇩🇰 Hillerød, Denmark

Dept. of Intensive Care, Viborg Hospital; 🇩🇰 Viborg, Denmark

Dept. of Intensive Care, Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Dept. of Intensive Care, Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Dept. of Intensive Care, Oulu University Hospital; 🇫🇮 Oulu, Finland

Dept. of Intensive Care, Tampere University Hospital; 🇫🇮 Tampere, Finland

Dept. of Intensive Care, University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Dept. of Intensive Care, Heerlen Hospital; 🇳🇱 Heerlen, Netherlands

Dept. of Intensive Care, Bergen University Hospital; 🇳🇴 Bergen, Norway

Dept. of Intensive Care, Akershus University Hospital; 🇳🇴 Lørenskog, Norway

Dept. of Intensive Care, Stavanger University Hospital; 🇳🇴 Stavanger, Norway

Dept. of Intensive Care, Århus University Hospital Nørrebrogade; 🇩🇰 Aarhus, Denmark

Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Dept. of Intensive Care, Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Dept. of Intensive Care, Herning Hospital; 🇩🇰 Herning, Denmark

Dept. of Intensive Care, Hjørring Hospital; 🇩🇰 Hjørring, Denmark

Dept. of Intensive Care, Holbæk Hospital; 🇩🇰 Holbæk, Denmark

Dept. of Intensive Care, Holstebro Hospital; 🇩🇰 Holstebro, Denmark

Dept. of Intensive Care, Køge University Hospital; 🇩🇰 Køge, Denmark

Dept. of Intensive Care, Vejle Hospital; 🇩🇰 Vejle, Denmark

Dept. of Intensive Care, Nykøbing Falster Sygehus; 🇩🇰 Nykøbing Falster, Denmark

Dept. of Intensive Care, Randers Hospital; 🇩🇰 Randers, Denmark

Dept. of Intensive Care, Roskilde Hospital; 🇩🇰 Roskilde, Denmark

Dept. of Intensive Care, Slagelse Hospital; 🇩🇰 Slagelse, Denmark

Dept. of Intensive Care, Oslo University Hospital; 🇳🇴 Oslo, Norway

Dept. of Intensive Care, Turku University Hospital; 🇫🇮 Turku, Finland

Dept. of Neurointensive Care, Copenhagen University Hospital Rigshospitalet; 🇩🇰 Copenhagen, Denmark