Trial · NCT01477320
Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.
NCT01477320, Not applicable, Completed, Mohamed Saad; results first posted 2018-01-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. Trials, record NCT01477320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01477320
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.
- NCT number
- NCT01477320
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 124 participants, actual
- Lead sponsor
- Mohamed Saad
- Conditions
- Gastrointestinal Hemorrhage, Clostridium Difficile Colitis
- Interventions
- Pantoprazole 40 mg IV daily and tube feed., Placebo and tube feed
- First posted
- 2011-11-22
- Last updated
- 2018-01-16
- Results first posted
- 2018-01-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With GI Bleeding | Subjects will be followed from date of randomization until discharge from the ICU or cessation of Enteral Nutrition (EN) and successful initiation of oral feeds up to 100 weeks. | 1. Incidence of overt GI bleeding (as defined by the presence of coffee ground emesis, hematemesis of bright red blood, melena, or hematochezia) seen with Proton Pump Inhibitor (PPI) and EN versus EN alone in critically ill patients. 2. Incidence of significant GI bleeding, defined by a 3-point decrease in hematocrit within 24 hours accompanied by signs of overt GI bleeding, or by an unexplained 6-point decrease in hematocrit during any 48 hour period. |
| Secondary | Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis. | Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With GI Bleeding | Subjects will be followed from date of randomization until discharge from the ICU or cessation of Enteral Nutrition (EN) and successful initiation of oral feeds up to 100 weeks. | participants | NUMBER | |
| SECONDARY | Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis. | Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With GI Bleeding | Pantoprazole 40mg IV Daily and Tube Feed | 1 | participants | ||
| Number of Subjects With GI Bleeding | Placebo and Tube Feed. | 1 | participants | ||
| Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis. | Pantoprazole 40mg IV Daily and Tube Feed | 1 | Participants | ||
| Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis. | Placebo and Tube Feed. | 3 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pantoprazole 40mg IV Daily and Tube Feed | 62 | |
| Overall Study | STARTED | Placebo and Tube Feed. | 62 | |
| Overall Study | COMPLETED | Pantoprazole 40mg IV Daily and Tube Feed | 55 | |
| Overall Study | COMPLETED | Placebo and Tube Feed. | 47 | |
| Overall Study | NOT COMPLETED | Pantoprazole 40mg IV Daily and Tube Feed | 7 | |
| Overall Study | NOT COMPLETED | Placebo and Tube Feed. | 15 |
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 |
|---|---|---|---|---|---|---|
| serious | GI bleed | Gastrointestinal disorders | Pantoprazole 40mg IV Daily and Tube Feed | 1 | 62 | 1 |
| serious | GI bleed | Gastrointestinal disorders | Placebo and Tube Feed. | 1 | 62 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pantoprazole 40mg IV Daily and Tube Feed | ||
| Total, all-cause mortality | Placebo and Tube Feed. | ||
| Total, other adverse events | Pantoprazole 40mg IV Daily and Tube Feed | 0 | 62 |
| Total, other adverse events | Placebo and Tube Feed. | 0 | 62 |
| Total, serious adverse events | Pantoprazole 40mg IV Daily and Tube Feed | 1 | 62 |
| Total, serious adverse events | Placebo and Tube Feed. | 1 | 62 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pantoprazole 40mg IV Daily and Tube Feed vs Placebo and Tube Feed.: Number of Subjects With GI Bleeding | Trial comparisons |
| Pantoprazole 40mg IV Daily and Tube Feed vs Placebo and Tube Feed.: Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis. | Trial comparisons |
| Pantoprazole 40mg IV Daily and Tube Feed vs Placebo and Tube Feed.: 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/NCT01477320
GET https://conductscience.org/api/trials/v1/NCT01477320/registered