Trial · NCT02467621
Stress Ulcer Prophylaxis in the Intensive Care Unit
NCT02467621, Phase 4, Completed, Dr. Morten Hylander Møller; results first posted 2019-06-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Stress Ulcer Prophylaxis in the Intensive Care Unit. Trials, record NCT02467621. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02467621
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stress Ulcer Prophylaxis in the Intensive Care Unit
- NCT number
- NCT02467621
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 3,350 participants, actual
- Lead sponsor
- Dr. Morten Hylander Møller
- Conditions
- Gastrointestinal Bleeding, Stress Ulcers
- Interventions
- Pantoprazole, Saline (0.9%)
- First posted
- 2015-06-10
- Last updated
- 2026-05-19
- Results first posted
- 2019-06-07
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mortality | 90 days | Landmark mortality 90-days after randomization |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | Mortality | 1 year | Data for landmark mortality 1 year after randomization. |
| Secondary | 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 |
| Secondary | 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. |
| Secondary | A Health Economic Analysis | 90 days | This has not been completed yet. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mortality | 90 days | Intention-to-treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia | Until ICU discharge, maximum 90 days | Intention-to-treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Important GI Bleeding | Until ICU discharge, maximum 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With One or More Infectious Adverse Events | Until ICU discharge, maximum 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mortality | 1 year | 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 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Days Alive Without Organ Support | Within 90 days | percentage of days | NUMBER | |
| SECONDARY | Number of Serious Adverse Reactions | Until ICU discharge, maximum 90 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | A Health Economic Analysis | 90 days |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mortality | Proton Pump Inhibitor (PPI) | 510 | Participants | ||
| Mortality | Normal Saline | 499 | Participants | ||
| Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia | Proton Pump Inhibitor (PPI) | 360 | Participants | ||
| Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia | Normal Saline | 372 | Participants | ||
| Number of Participants With Clinically Important GI Bleeding | Proton Pump Inhibitor (PPI) | 41 | Participants | ||
| Number of Participants With Clinically Important GI Bleeding | Normal Saline | 69 | Participants | ||
| Number of Participants With One or More Infectious Adverse Events | Proton Pump Inhibitor (PPI) | 276 | Participants | ||
| Number of Participants With One or More Infectious Adverse Events | Normal Saline | 279 | Participants | ||
| Mortality | Proton Pump Inhibitor (PPI) | 610 | Participants | ||
| Mortality | Normal Saline | 601 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Proton Pump Inhibitor (PPI) | 1,645 | |
| Overall Study | STARTED | Normal Saline | 1,653 | |
| Overall Study | COMPLETED | Proton Pump Inhibitor (PPI) | 1,644 | |
| Overall Study | COMPLETED | Normal Saline | 1,647 | |
| Overall Study | NOT COMPLETED | Proton Pump Inhibitor (PPI) | 1 | |
| Overall Study | NOT COMPLETED | Normal Saline | 6 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Clinically important events | General disorders | Proton Pump Inhibitor (PPI) | 360 | 1,644 | |
| other | Clinically important events | General disorders | Normal Saline | 372 | 1,647 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Proton Pump Inhibitor (PPI) | 610 | 1,635 |
| Total, all-cause mortality | Normal Saline | 601 | 1,626 |
| Total, other adverse events | Proton Pump Inhibitor (PPI) | 360 | 1,644 |
| Total, other adverse events | Normal Saline | 372 | 1,647 |
| Total, serious adverse events | Proton Pump Inhibitor (PPI) | 0 | 1,644 |
| Total, serious adverse events | Normal Saline | 0 | 1,647 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Proton Pump Inhibitor (PPI) vs Normal Saline: Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia | Trial comparisons |
| Proton Pump Inhibitor (PPI) vs Normal Saline: Number of Participants With One or More Infectious Adverse Events | Trial comparisons |
| Proton Pump Inhibitor (PPI) vs Normal Saline: Number of Serious Adverse Reactions | Trial comparisons |
| Proton Pump Inhibitor (PPI) vs Normal Saline: Mortality | Trial comparisons |
| Proton Pump Inhibitor (PPI) vs Normal Saline: deaths from any cause | Trial comparisons |
| Proton Pump Inhibitor (PPI) vs Normal Saline: Mortality | Trial comparisons |
| Proton Pump Inhibitor (PPI) vs Normal Saline: Number of Participants With Clinically Important GI Bleeding | Trial comparisons |
| Proton Pump Inhibitor (PPI) vs Normal Saline: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02467621
GET https://conductscience.org/api/trials/v1/NCT02467621/registered