Trial Outcomes & Findings for Stress Ulcer Prophylaxis in the Intensive Care Unit (NCT NCT02467621)
NCT ID: NCT02467621
Last Updated: 2022-11-15
Results Overview
Landmark mortality 90-days after randomization
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
3350 participants
Primary outcome timeframe
90 days
Results posted on
2022-11-15
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
1645
|
1653
|
|
Overall Study
COMPLETED
|
1644
|
1647
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stress Ulcer Prophylaxis in the Intensive Care Unit
Baseline characteristics by cohort
| Measure |
Proton Pump Inhibitor (PPI)
n=1644 Participants
Pantoprazole 40 mg
Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge
|
Normal Saline
n=1647 Participants
Saline (0.9%)
Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
|
Total
n=3291 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
67 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
605 Participants
n=5 Participants
|
580 Participants
n=7 Participants
|
1185 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1039 Participants
n=5 Participants
|
1067 Participants
n=7 Participants
|
2106 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1644 Participants
n=5 Participants
|
1647 Participants
n=7 Participants
|
3291 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
88 participants
n=5 Participants
|
84 participants
n=7 Participants
|
172 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
96 participants
n=5 Participants
|
101 participants
n=7 Participants
|
197 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
128 participants
n=5 Participants
|
130 participants
n=7 Participants
|
258 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
1061 participants
n=5 Participants
|
1064 participants
n=7 Participants
|
2125 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
34 participants
n=5 Participants
|
33 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
237 participants
n=5 Participants
|
235 participants
n=7 Participants
|
472 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Intention-to-treat
Landmark mortality 90-days after randomization
Outcome measures
| Measure |
Proton Pump Inhibitor (PPI)
n=1642 Participants
Pantoprazole 40 mg
Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge
|
Normal Saline
n=1640 Participants
Saline (0.9%)
Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
|
|---|---|---|
|
Mortality
|
510 Participants
|
499 Participants
|
SECONDARY outcome
Timeframe: Until ICU discharge, maximum 90 daysPopulation: Intention-to-treat
Composite outcome of the number of participants with one or more of the mentioned conditions in the ICU
Outcome measures
| Measure |
Proton Pump Inhibitor (PPI)
n=1644 Participants
Pantoprazole 40 mg
Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge
|
Normal Saline
n=1647 Participants
Saline (0.9%)
Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
|
|---|---|---|
|
Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia
|
360 Participants
|
372 Participants
|
SECONDARY outcome
Timeframe: Until ICU discharge, maximum 90 daysNumber of participants with one or more episodes of clinically important GI bleeding in the ICU
Outcome measures
| Measure |
Proton Pump Inhibitor (PPI)
n=1644 Participants
Pantoprazole 40 mg
Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge
|
Normal Saline
n=1647 Participants
Saline (0.9%)
Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
|
|---|---|---|
|
Number of Participants With Clinically Important GI Bleeding
|
41 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: Until ICU discharge, maximum 90 daysNumber of participants with one or more episodes of pneumonia or clostridium difficile infection in the ICU
Outcome measures
| Measure |
Proton Pump Inhibitor (PPI)
n=1644 Participants
Pantoprazole 40 mg
Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge
|
Normal Saline
n=1647 Participants
Saline (0.9%)
Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
|
|---|---|---|
|
Number of Participants With One or More Infectious Adverse Events
|
276 Participants
|
279 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 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
Data for landmark mortality 1 year after randomization.
Outcome measures
| Measure |
Proton Pump Inhibitor (PPI)
n=1635 Participants
Pantoprazole 40 mg
Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge
|
Normal Saline
n=1626 Participants
Saline (0.9%)
Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
|
|---|---|---|
|
Mortality
|
610 Participants
|
601 Participants
|
SECONDARY outcome
Timeframe: Within 90 daysPercentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
Outcome measures
| Measure |
Proton Pump Inhibitor (PPI)
n=1644 Participants
Pantoprazole 40 mg
Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge
|
Normal Saline
n=1647 Participants
Saline (0.9%)
Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
|
|---|---|---|
|
Percentage of Days Alive Without Organ Support
|
92 percentage of days
|
92 percentage of days
|
SECONDARY outcome
Timeframe: Until ICU discharge, maximum 90 daysSerious adverse reactions are: anaphylactic reactions, agranulocytosis, pancytopenia, acute hepatic failure, Steven Johnsons Syndrome and toxic epidermal necrolysis, interstitial nephritis and angioedema.
Outcome measures
| Measure |
Proton Pump Inhibitor (PPI)
n=1644 Participants
Pantoprazole 40 mg
Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge
|
Normal Saline
n=1647 Participants
Saline (0.9%)
Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
|
|---|---|---|
|
Number of Serious Adverse Reactions
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 90 daysThis has not been completed yet.
Outcome measures
Outcome data not reported
Adverse Events
Proton Pump Inhibitor (PPI)
Serious events: 0 serious events
Other events: 360 other events
Deaths: 610 deaths
Normal Saline
Serious events: 0 serious events
Other events: 372 other events
Deaths: 601 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Proton Pump Inhibitor (PPI)
n=1644 participants at risk
Pantoprazole 40 mg
Pantoprazole: 40 mg x 1 daily intravenously from ICU admission to ICU discharge
|
Normal Saline
n=1647 participants at risk
Saline (0.9%)
Saline (0.9%): 10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
|
|---|---|---|
|
General disorders
Clinically important events
|
21.9%
360/1644 • 90 days (for mortality 1 year)
|
22.6%
372/1647 • 90 days (for mortality 1 year)
|
Additional Information
Dr. Morten Hylander Møller
Copenhagen University Hospital Rigshospitalet, Dept. of Intensive Care 4131
Phone: 22555343
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place