Clostridium Difficile Colitis, Gastrointestinal Hemorrhage
Conditions
Keywords
Enteral Nutrition, Stress Ulcer Prophylaxis, Critically Ill Patients, Overt and significant GI bleeding, Stress gastropathy, Clostridium Difficile pseudomembranous colitis, Vital AF, Small peptide fish oil structured lipids, Fructose oligosaccharide
Brief 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.
Interventions
DRUGPantoprazole 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.
OTHERPlacebo and tube feed
Patients randomized to Placebo group placebo Comparator will receive tube feed plus an Placebo.
Sponsors
Abbott Nutrition
University of Louisville
Mohamed Saad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Admission to the medical ICU at University of Louisville Hospital or Jewish Hospital * Expected need for mechanical ventilation \> 48 hours * No contraindication to EN within the first 24 hours after admission to the ICU
Exclusion criteria
* Evidence of active GI bleeding during current hospitalization prior to study entry * Admission to ICU with primary diagnosis of burn injury * Closed head injury or increased intracranial pressure * Partial or complete gastrectomy * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 55 |
| Placebo and Tube Feed. Placebo and tube feed: Patients randomized to Placebo group placebo Comparator will receive tube feed plus an Placebo. | 47 |
| Total | 102 |
Baseline characteristics
| Characteristic | Pantoprazole 40mg IV Daily and Tube Feed | Placebo and Tube Feed. | Total |
|---|---|---|---|
| Age, Continuous | 62 years | 58 years | 60 years |
| Region of Enrollment United States | 55 participants | 47 participants | 102 participants |
| Sex: Female, Male Female | 25 Participants | 19 Participants | 44 Participants |
| Sex: Female, Male Male | 30 Participants | 28 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 62 | 0 / 62 |
| serious Total, serious adverse events | 1 / 62 | 1 / 62 |
Outcome results
Primary
Number of Subjects With GI Bleeding
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pantoprazole 40mg IV Daily and Tube Feed | Number of Subjects With GI Bleeding | 1 participants |
| Placebo and Tube Feed. | Number of Subjects With GI Bleeding | 1 participants |
Secondary
Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis.
Time frame: Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pantoprazole 40mg IV Daily and Tube Feed | Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis. | 1 Participants |
| Placebo and Tube Feed. | Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis. | 3 Participants |