Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
3350 participants
INTERVENTIONAL
2016-01-31
2018-01-21
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Proton pump inhibitor (PPI)
Pantoprazole 40 mg
Pantoprazole
40 mg x 1 daily intravenously from ICU admission to ICU discharge
Normal saline
Saline (0.9%)
Saline (0.9%)
10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
Interventions
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Pantoprazole
40 mg x 1 daily intravenously from ICU admission to ICU discharge
Saline (0.9%)
10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
Dr. Morten Hylander Møller
OTHER
Responsible Party
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Dr. Morten Hylander Møller
Principal investigator
Principal Investigators
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Morten Hylander Møller, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Anders Perner, MD, PhD
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Locations
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Dept. of Intensive Care, Aalborg University Hospital
Aalborg, , Denmark
Dept. of Intensive Care, Århus University Hospital Nørrebrogade
Aarhus, , Denmark
Dept. of Intensive Care, Århus University Hospital Skejby
Aarhus, , Denmark
Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet
Copenhagen, , Denmark
Dept. of Neurointensive Care, Copenhagen University Hospital Rigshospitalet
Copenhagen, , Denmark
Dept. of Intensive Care, Bispebjerg Hospital
Copenhagen, , Denmark
Dept. of Intensive Care, Copenhagen University Hospital Herlev
Herlev, , Denmark
Dept. of Intensive Care, Herning Hospital
Herning, , Denmark
Dept. of Intensive Care, Hillerød Hospital
Hillerød, , 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, 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, Vejle Hospital
Vejle, , 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, Turku University Hospital
Turku, , 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, Oslo University Hospital
Oslo, , Norway
Dept. of Intensive Care, Stavanger University Hospital
Stavanger, , Norway
Dept. of Intensive Care, Basel University Hospital
Basel, , Switzerland
Dept. of Intensive Care, Bern University Hospital
Bern, , Switzerland
Dept. of Intensive Care, University Hospital of Wales
Cardiff, , United Kingdom
Countries
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References
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Krag M, Perner A, Wetterslev J, Wise MP, Hylander Moller M. Stress ulcer prophylaxis versus placebo or no prophylaxis in critically ill patients. A systematic review of randomised clinical trials with meta-analysis and trial sequential analysis. Intensive Care Med. 2014 Jan;40(1):11-22. doi: 10.1007/s00134-013-3125-3. Epub 2013 Oct 19.
Krag M, Perner A, Wetterslev J, Wise MP, Borthwick M, Bendel S, McArthur C, Cook D, Nielsen N, Pelosi P, Keus F, Guttormsen AB, Moller AD, Moller MH; SUP-ICU co-authors. Prevalence and outcome of gastrointestinal bleeding and use of acid suppressants in acutely ill adult intensive care patients. Intensive Care Med. 2015 May;41(5):833-45. doi: 10.1007/s00134-015-3725-1. Epub 2015 Apr 10.
Halling CMB, Moller MH, Marker S, Krag M, Kjellberg J, Perner A, Gyrd-Hansen D. The effects of pantoprazole vs. placebo on 1-year outcomes, resource use and employment status in ICU patients at risk for gastrointestinal bleeding: a secondary analysis of the SUP-ICU trial. Intensive Care Med. 2022 Apr;48(4):426-434. doi: 10.1007/s00134-022-06631-2. Epub 2022 Feb 5.
Granholm A, Marker S, Krag M, Zampieri FG, Thorsen-Meyer HC, Kaas-Hansen BS, van der Horst ICC, Lange T, Wetterslev J, Perner A, Moller MH. Heterogeneity of treatment effect of prophylactic pantoprazole in adult ICU patients: a post hoc analysis of the SUP-ICU trial. Intensive Care Med. 2020 Apr;46(4):717-726. doi: 10.1007/s00134-019-05903-8. Epub 2020 Jan 14.
Granholm A, Lange T, Anthon CT, Marker S, Krag M, Meyhoff TS, Wise MP, Borthwick M, Bendel S, Keus F, Guttormsen AB, Schefold JC, Wetterslev J, Perner A, Moller MH. Time to onset of gastrointestinal bleeding in the SUP-ICU trial: A pre-planned substudy. Acta Anaesthesiol Scand. 2019 Nov;63(10):1346-1356. doi: 10.1111/aas.13459. Epub 2019 Sep 11.
Granholm A, Marker S, Krag M, Zampieri FG, Thorsen-Meyer HC, Kaas-Hansen BS, van der Horst ICC, Lange T, Wetterslev J, Perner A, Moller MH. Heterogeneity of treatment effect of stress ulcer prophylaxis in ICU patients: A secondary analysis protocol. Acta Anaesthesiol Scand. 2019 Oct;63(9):1251-1256. doi: 10.1111/aas.13432. Epub 2019 Jul 18.
Marker S, Krag M, Perner A, Wetterslev J, Lange T, Wise MP, Borthwick M, Bendel S, Keus F, Guttormsen AB, Schefold JC, Rasmussen BS, Elkmann T, Bestle M, Arenkiel B, Laake JH, Kamper MK, Lang M, Pawlowicz-Dworzanska MB, Karlsson S, Liisanantti J, Dey N, Knudsen H, Granholm A, Moller MH; SUP-ICU trial investigators. Pantoprazole in ICU patients at risk for gastrointestinal bleeding-1-year mortality in the SUP-ICU trial. Acta Anaesthesiol Scand. 2019 Oct;63(9):1184-1190. doi: 10.1111/aas.13436. Epub 2019 Jul 19.
Marker S, Perner A, Wetterslev J, Krag M, Lange T, Wise MP, Borthwick M, Bendel S, Keus F, Guttormsen AB, Schefold JC, Moller MH; SUP-ICU investigators. Pantoprazole prophylaxis in ICU patients with high severity of disease: a post hoc analysis of the placebo-controlled SUP-ICU trial. Intensive Care Med. 2019 May;45(5):609-618. doi: 10.1007/s00134-019-05589-y. Epub 2019 Mar 12.
Krag M, Marker S, Perner A, Wetterslev J, Wise MP, Schefold JC, Keus F, Guttormsen AB, Bendel S, Borthwick M, Lange T, Rasmussen BS, Siegemund M, Bundgaard H, Elkmann T, Jensen JV, Nielsen RD, Liboriussen L, Bestle MH, Elkjaer JM, Palmqvist DF, Backlund M, Laake JH, Badstolokken PM, Gronlund J, Breum O, Walli A, Winding R, Iversen S, Jarnvig IL, White JO, Brand B, Madsen MB, Quist L, Thornberg KJ, Moller A, Wiis J, Granholm A, Anthon CT, Meyhoff TS, Hjortrup PB, Aagaard SR, Andreasen JB, Sorensen CA, Haure P, Hauge J, Hollinger A, Scheuzger J, Tuchscherer D, Vuilliomenet T, Takala J, Jakob SM, Vang ML, Paelestik KB, Andersen KLD, van der Horst ICC, Dieperink W, Fjolner J, Kjer CKW, Solling C, Solling CG, Karttunen J, Morgan MPG, Sjobo B, Engstrom J, Agerholm-Larsen B, Moller MH; SUP-ICU trial group. Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU. N Engl J Med. 2018 Dec 6;379(23):2199-2208. doi: 10.1056/NEJMoa1714919. Epub 2018 Oct 24.
Krag M, Perner A, Wetterslev J, Wise MP, Borthwick M, Bendel S, Pelosi P, Keus F, Guttormsen AB, Schefold JC, Moller MH; SUP-ICU investigators. Stress ulcer prophylaxis with a proton pump inhibitor versus placebo in critically ill patients (SUP-ICU trial): study protocol for a randomised controlled trial. Trials. 2016 Apr 19;17(1):205. doi: 10.1186/s13063-016-1331-3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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RH-ITA-006
Identifier Type: -
Identifier Source: org_study_id
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