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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Copenhagen Trial Unit, Center for Clinical Intervention Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton pump inhibitor (PPI) | Experimental | Pantoprazole 40 mg |
|
| Normal saline | Placebo Comparator | Saline (0.9%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole | Drug | 40 mg x 1 daily intravenously from ICU admission to ICU discharge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Landmark mortality 90-days after randomization | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia | Composite outcome of the number of participants with one or more of the mentioned conditions in the ICU | Until ICU discharge, maximum 90 days |
| Number of Participants With Clinically Important GI Bleeding |
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INCLUSION CRITERIA:
Acute admission to the ICU
Age ≥ 18 years
One or more of the following risk factors:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Morten Hylander Møller, MD, PhD | Rigshospitalet, Denmark | Principal Investigator |
| Anders Perner, MD, PhD | Rigshospitalet, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Intensive Care, Aalborg University Hospital | Aalborg | 9000 | Denmark | |||
| Dept. of Intensive Care, Århus University Hospital Nørrebrogade |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24141808 | Background | 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. | |
| 25860444 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Proton Pump Inhibitor (PPI) | Pantoprazole 40 mg Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge |
| FG001 | Normal Saline | Saline (0.9%) Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2017 |
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| Saline (0.9%) | Other | 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge |
|
Number of participants with one or more episodes of clinically important GI bleeding in the ICU |
| Until ICU discharge, maximum 90 days |
| Number of Participants With One or More Infectious Adverse Events | Number of participants with one or more episodes of pneumonia or clostridium difficile infection in the ICU | Until ICU discharge, maximum 90 days |
| Mortality | Data for landmark mortality 1 year after randomization. | 1 year |
| Percentage of Days Alive Without Organ Support | Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy | Within 90 days |
| Number of Serious Adverse Reactions | Serious adverse reactions are: anaphylactic reactions, agranulocytosis, pancytopenia, acute hepatic failure, Steven Johnsons Syndrome and toxic epidermal necrolysis, interstitial nephritis and angioedema. | Until ICU discharge, maximum 90 days |
| A Health Economic Analysis | This has not been completed yet. | 90 days |
| Aarhus |
| 8000 |
| Denmark |
| Dept. of Intensive Care, Ã…rhus University Hospital Skejby | Aarhus | 8000 | Denmark |
| Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet | Copenhagen | 2100 | Denmark |
| Dept. of Neurointensive Care, Copenhagen University Hospital Rigshospitalet | Copenhagen | 2100 | Denmark |
| Dept. of Intensive Care, Bispebjerg Hospital | Copenhagen | 2400 | Denmark |
| Dept. of Intensive Care, Copenhagen University Hospital Herlev | Herlev | 2730 | Denmark |
| 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, Køge University Hospital | Køge | 4600 | Denmark |
| Dept. of Intensive Care, Nykøbing Falster Sygehus | Nykøbing Falster | 4800 | Denmark |
| 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, Vejle Hospital | Vejle | 7100 | Denmark |
| Dept. of Intensive Care, Viborg Hospital | Viborg | 8800 | Denmark |
| Dept. of Intensive Care, Helsinki University Hospital | Helsinki | 00120 | Finland |
| Dept. of Intensive Care, Kuopio University Hospital | Kuopio | 70029 | Finland |
| Dept. of Intensive Care, Oulu University Hospital | Oulu | 90210 | Finland |
| 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 Medical Center Groningen | Groningen | 9713 | Netherlands |
| Dept. of Intensive Care, Heerlen Hospital | Heerlen | 6419 | Netherlands |
| Dept. of Intensive Care, Bergen University Hospital | Bergen | 5021 | Norway |
| Dept. of Intensive Care, Akershus University Hospital | Lørenskog | 1478 | Norway |
| Dept. of Intensive Care, Oslo University Hospital | Oslo | 0450 | Norway |
| Dept. of Intensive Care, Stavanger University Hospital | Stavanger | 4011 | Norway |
| Dept. of Intensive Care, Basel University Hospital | Basel | 4056 | Switzerland |
| Dept. of Intensive Care, Bern University Hospital | Bern | 3010 | Switzerland |
| Dept. of Intensive Care, University Hospital of Wales | Cardiff | United Kingdom |
| 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. |
| 35122105 | Derived | 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. |
| 31938829 | Derived | 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. |
| 31441031 | Derived | 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. |
| 31321771 | Derived | 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. |
| 31282567 | Derived | 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. |
| 30863936 | Derived | 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. |
| 30354950 | Derived | 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. |
| 27093939 | Derived | 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. |
|
| COMPLETED | 1644/1647 in the secondary outcome analyses 1642/1640 in the primary outcome analysis |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Proton Pump Inhibitor (PPI) | Pantoprazole 40 mg Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge |
| BG001 | Normal Saline | Saline (0.9%) Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality | Landmark mortality 90-days after randomization | Intention-to-treat | Posted | Count of Participants | Participants | 90 days |
|
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| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia | Composite outcome of the number of participants with one or more of the mentioned conditions in the ICU | Intention-to-treat | Posted | Count of Participants | Participants | Until ICU discharge, maximum 90 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Important GI Bleeding | Number of participants with one or more episodes of clinically important GI bleeding in the ICU | Posted | Count of Participants | Participants | Until ICU discharge, maximum 90 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With One or More Infectious Adverse Events | Number of participants with one or more episodes of pneumonia or clostridium difficile infection in the ICU | Posted | Count of Participants | Participants | Until ICU discharge, maximum 90 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Mortality | Data for landmark mortality 1 year after randomization. | Twenty-one patients were lost to follow-up, as compared to the primary outcome (90-day mortality): 7 patients in the PPI arm and 14 patients in the placebo arm | Posted | Count of Participants | Participants | 1 year |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Days Alive Without Organ Support | Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy | Posted | Number | percentage of days | Within 90 days |
|
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| Secondary | Number of Serious Adverse Reactions | Serious adverse reactions are: anaphylactic reactions, agranulocytosis, pancytopenia, acute hepatic failure, Steven Johnsons Syndrome and toxic epidermal necrolysis, interstitial nephritis and angioedema. | Posted | Count of Participants | Participants | Until ICU discharge, maximum 90 days |
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| Secondary | A Health Economic Analysis | This has not been completed yet. | Not Posted | Jan 2030 | 90 days | Participants |
90 days (for mortality 1 year)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Proton Pump Inhibitor (PPI) | Pantoprazole 40 mg Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge | 610 | 1,635 | 0 | 1,644 | 360 | 1,644 |
| EG001 | Normal Saline | Saline (0.9%) Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge | 601 | 1,626 | 0 | 1,647 | 372 | 1,647 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinically important events | General disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Morten Hylander Møller | Copenhagen University Hospital Rigshospitalet, Dept. of Intensive Care 4131 | 22555343 | +45 | mortenhylander@gmail.com |
| Oct 29, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D004381 | Duodenal Ulcer |
| D011014 | Pneumonia |
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Norway |
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| Finland |
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| Denmark |
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| United Kingdom |
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| Switzerland |
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