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| Name | Class |
|---|---|
| Abbott Nutrition | INDUSTRY |
| University of Louisville | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pantoprazole 40mg IV daily and tube feed | Active Comparator |
| |
| Placebo and tube feed. | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole 40 mg IV daily and tube feed. | Drug | Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Saad, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville hospital | Louisville | Kentucky | 40202 | United States |
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Recruitment started in July 2013 in the medical ICU of University of Louisville Hospital. In July 2014, a second recruitment site (medical ICU at Jewish Hospital) was added as a second site for recruitment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pantoprazole 40mg IV Daily and Tube Feed | Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily. |
| FG001 | Placebo and Tube Feed. | Placebo and tube feed: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pantoprazole 40mg IV Daily and Tube Feed | Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily. |
| BG001 | Placebo and Tube Feed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The patient excluded from analysis were extubated too soon after enrollment before starting tube feed |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With GI Bleeding |
| Posted | Number | participants | 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. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pantoprazole 40mg IV Daily and Tube Feed | Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI bleed | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mohamed Saad | University of Louisville | 5028525841 | mohamed.saad@louisville.edu |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D004761 | Enterocolitis, Pseudomembranous |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| Placebo and tube feed | Other | Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo. |
|
|
Placebo and tube feed: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo. |
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo and Tube Feed. | Placebo and tube feed: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo. |
|
|
| Secondary | Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis. | Posted | Count of Participants | Participants | Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks. |
|
|
|
| 1 |
| 62 |
| 0 |
| 62 |
| EG001 | Placebo and Tube Feed. | Placebo and tube feed: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo. | 1 | 62 | 0 | 62 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D007410 | Intestinal Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |