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Trial record 1 of 2 for:    sup-icu
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Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU)

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ClinicalTrials.gov Identifier: NCT02467621
Recruitment Status : Completed
First Posted : June 10, 2015
Results First Posted : June 7, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
Information provided by (Responsible Party):
Dr. Morten Hylander Møller, Scandinavian Critical Care Trials Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Gastrointestinal Bleeding
Stress Ulcers
Interventions Drug: Pantoprazole
Other: Saline (0.9%)
Enrollment 3350
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Proton Pump Inhibitor (PPI) Normal Saline
Hide Arm/Group Description

Pantoprazole 40 mg

Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge

Saline (0.9%)

Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge

Period Title: Overall Study
Started [1] 1645 1653
Completed [2] 1644 1647
Not Completed 1 6
[1]

52 patients were randomised in error BEFORE receiving the first dose of IMP/placebo.

3350-52=3298

[2]
1644/1647 in the secondary outcome analyses 1642/1640 in the primary outcome analysis
Arm/Group Title Proton Pump Inhibitor (PPI) Normal Saline Total
Hide Arm/Group Description

Pantoprazole 40 mg

Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge

Saline (0.9%)

Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge

Total of all reporting groups
Overall Number of Baseline Participants 1644 1647 3291
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 1644 participants 1647 participants 3291 participants
67
(56 to 75)
67
(55 to 75)
67
(55 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1644 participants 1647 participants 3291 participants
Female
605
  36.8%
580
  35.2%
1185
  36.0%
Male
1039
  63.2%
1067
  64.8%
2106
  64.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1644 participants 1647 participants 3291 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1644
 100.0%
1647
 100.0%
3291
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1644 participants 1647 participants 3291 participants
Netherlands 88 84 172
Norway 96 101 197
Finland 128 130 258
Denmark 1061 1064 2125
United Kingdom 34 33 67
Switzerland 237 235 472
1.Primary Outcome
Title Mortality
Hide Description Landmark mortality 90-days after randomization
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Proton Pump Inhibitor (PPI) Normal Saline
Hide Arm/Group Description:

Pantoprazole 40 mg

Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge

Saline (0.9%)

Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge

Overall Number of Participants Analyzed 1642 1640
Measure Type: Count of Participants
Unit of Measure: Participants
510
  31.1%
499
  30.4%
2.Secondary Outcome
Title Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia
Hide Description Composite outcome of the number of participants with one or more of the mentioned conditions in the ICU
Time Frame Until ICU discharge, maximum 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Proton Pump Inhibitor (PPI) Normal Saline
Hide Arm/Group Description:

Pantoprazole 40 mg

Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge

Saline (0.9%)

Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge

Overall Number of Participants Analyzed 1644 1647
Measure Type: Count of Participants
Unit of Measure: Participants
360
  21.9%
372
  22.6%
3.Secondary Outcome
Title Number of Participants With Clinically Important GI Bleeding
Hide Description Number of participants with one or more episodes of clinically important GI bleeding in the ICU
Time Frame Until ICU discharge, maximum 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proton Pump Inhibitor (PPI) Normal Saline
Hide Arm/Group Description:

Pantoprazole 40 mg

Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge

Saline (0.9%)

Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge

Overall Number of Participants Analyzed 1644 1647
Measure Type: Count of Participants
Unit of Measure: Participants
41
   2.5%
69
   4.2%
4.Secondary Outcome
Title Number of Participants With One or More Infectious Adverse Events
Hide Description Number of participants with one or more episodes of pneumonia or clostridium difficile infection in the ICU
Time Frame Until ICU discharge, maximum 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proton Pump Inhibitor (PPI) Normal Saline
Hide Arm/Group Description:

Pantoprazole 40 mg

Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge

Saline (0.9%)

Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge

Overall Number of Participants Analyzed 1644 1647
Measure Type: Count of Participants
Unit of Measure: Participants
276
  16.8%
279
  16.9%
5.Secondary Outcome
Title Mortality
Hide Description Data for landmark mortality 1 year after randomization.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Proton Pump Inhibitor (PPI) Normal Saline
Hide Arm/Group Description:

Pantoprazole 40 mg

Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge

Saline (0.9%)

Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge

Overall Number of Participants Analyzed 1635 1626
Measure Type: Count of Participants
Unit of Measure: Participants
610
  37.3%
601
  37.0%
6.Secondary Outcome
Title Percentage of Days Alive Without Organ Support
Hide Description Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
Time Frame Within 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proton Pump Inhibitor (PPI) Normal Saline
Hide Arm/Group Description:

Pantoprazole 40 mg

Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge

Saline (0.9%)

Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge

Overall Number of Participants Analyzed 1644 1647
Measure Type: Number
Unit of Measure: percentage of days
92 92
7.Secondary Outcome
Title Number of Serious Adverse Reactions
Hide Description Serious adverse reactions are: anaphylactic reactions, agranulocytosis, pancytopenia, acute hepatic failure, Steven Johnsons Syndrome and toxic epidermal necrolysis, interstitial nephritis and angioedema.
Time Frame Until ICU discharge, maximum 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proton Pump Inhibitor (PPI) Normal Saline
Hide Arm/Group Description:

Pantoprazole 40 mg

Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge

Saline (0.9%)

Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge

Overall Number of Participants Analyzed 1644 1647
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title A Health Economic Analysis
Hide Description This has not been completed yet.
Time Frame 90 days
Outcome Measure Data Not Reported
Time Frame 90 days (for mortality 1 year)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Proton Pump Inhibitor (PPI) Normal Saline
Hide Arm/Group Description

Pantoprazole 40 mg

Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge

Saline (0.9%)

Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge

All-Cause Mortality
Proton Pump Inhibitor (PPI) Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   610/1635 (37.31%)   601/1626 (36.96%) 
Hide Serious Adverse Events
Proton Pump Inhibitor (PPI) Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1644 (0.00%)   0/1647 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Proton Pump Inhibitor (PPI) Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   360/1644 (21.90%)   372/1647 (22.59%) 
General disorders     
Clinically important events   360/1644 (21.90%)  372/1647 (22.59%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Morten Hylander Møller
Organization: Copenhagen University Hospital Rigshospitalet, Dept. of Intensive Care 4131
Phone: 22555343 ext +45
EMail: mortenhylander@gmail.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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, Elkjær JM, Palmqvist DF, Bäcklund M, Laake JH, Bådstøløkken PM, Grönlund J, Breum O, Walli A, Winding R, Iversen S, Jarnvig IL, White JO, Brand B, Madsen MB, Quist L, Thornberg KJ, Møller A, Wiis J, Granholm A, Anthon CT, Meyhoff TS, Hjortrup PB, Aagaard SR, Andreasen JB, Sørensen CA, Haure P, Hauge J, Hollinger A, Scheuzger J, Tuchscherer D, Vuilliomenet T, Takala J, Jakob SM, Vang ML, Pælestik KB, Andersen KLD, van der Horst ICC, Dieperink W, Fjølner J, Kjer CKW, Sølling C, Sølling CG, Karttunen J, Morgan MPG, Sjøbø B, Engstrøm J, Agerholm-Larsen B, Møller 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.
Layout table for additonal information
Responsible Party: Dr. Morten Hylander Møller, Scandinavian Critical Care Trials Group
ClinicalTrials.gov Identifier: NCT02467621    
Other Study ID Numbers: RH-ITA-006
First Submitted: June 5, 2015
First Posted: June 10, 2015
Results First Submitted: October 29, 2018
Results First Posted: June 7, 2019
Last Update Posted: October 3, 2019