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NCT01477320 · ClinicalTrials.gov registry record · NA
Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.
A NA study of Clostridium Difficile Colitis and Gastrointestinal Hemorrhage, sponsored by Mohamed Saad.
- Completed
- Registry status
- NA
- Development phase
- 124
- Enrollment target
- 1
- Study location
NCT01477320: Completed NA study of Clostridium Difficile Colitis and Gastrointestinal Hemorrhage, sponsored by Mohamed Saad.
NCT01477320 is a NA study of Clostridium Difficile Colitis and Gastrointestinal Hemorrhage that has completed, run by Mohamed Saad. The registered enrollment target is 124 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01477320, a NA study of Clostridium Difficile Colitis and Gastrointestinal Hemorrhage, has completed, sponsored by Mohamed Saad.
- COMPLETED
- Registry status
- NA
- Development phase
- 124 participants
- Enrollment target
- 1
- Study location
Study Summary
study is to determine if proton pump inhibitors plus enteral nutrition is superior to enteral nutrition alone as a stress ulcer prophylaxis strategy in critically ill patients in terms of incidence of overt and significant GI bleeding related to stress gastropathy.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Pantoprazole 40 mg IV daily and tube feed.
- OTHER Placebo and tube feed
Study Locations (1)
Kentucky
- University of Louisville hospital - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-07 |
| Phase | NA |
What the finished NCT01477320 record still lists
NCT01477320 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Clostridium Difficile Colitis appearing as the primary indexed condition, and to 2 interventions - of which Pantoprazole 40 mg IV daily and tube feed. is the first listed.
NCT01477320 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT01477320 about?
NCT01477320 is a clinical study titled "Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.". study is to determine if proton pump inhibitors plus enteral nutrition is superior to enteral nutrition alone as a stress ulcer prophylaxis strategy in critically ill patients in terms of incidence of overt and significant GI bleeding related to stress gastropathy.
What is the current status of trial NCT01477320?
This trial is currently completed. It is a NA study. The enrollment target is 124 participants. The study started on 2013-09. Estimated completion is 2016-07.
What conditions does trial NCT01477320 study?
This clinical trial studies the following conditions: Clostridium Difficile Colitis, Gastrointestinal Hemorrhage.
What interventions are being tested in trial NCT01477320?
The interventions under investigation include: Pantoprazole 40 mg IV daily and tube feed. (DRUG), Placebo and tube feed (OTHER).
Who is sponsoring clinical trial NCT01477320?
This trial is sponsored by Mohamed Saad, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01477320 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01477320's enrollment target sits among peer trials
124 758th of 2000 higher than 1,239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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