Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.
Overview[ - collapse ][ - ]
Purpose | 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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Condition | Gastrointestinal Hemorrhage Clostridium Difficile Colitis |
Intervention | Drug: Pantoprazole 40 mg IV daily and tube feed. Other: Placebo and tube feed |
Phase | N/A |
Sponsor | Rodrigo Cavallazzi |
Responsible Party | University of Louisville |
ClinicalTrials.gov Identifier | NCT01477320 |
First Received | October 4, 2011 |
Last Updated | July 1, 2013 |
Last verified | July 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | October 4, 2011 |
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Last Updated Date | July 1, 2013 |
Start Date | August 2013 |
Estimated Primary Completion Date | March 2015 |
Current Primary Outcome Measures | GI bleeding [Time Frame: Time to event :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] [Designated as safety issue: Yes]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. 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. |
Current Secondary Outcome Measures | 1. Cost to the pharmacy for care related to stress ulcer prophylaxis and treatment of GI bleeding. 2.Incidence of ICU-acquired C. Difficile pseudomembranous colitis. [Time Frame: Time to event: Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds.] [Designated as safety issue: Yes]Cost to the pharmacy for care related to stress ulcer prophylaxis and treatment of GI bleeding (overt or significant) for patients receiving a PPI agent plus EN versus patients placed on EN alone. |
Descriptive Information[ + expand ][ + ]
Brief Title | Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. |
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Official Title | Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. Prospective, Double-blind, Randomized, Placebo-controlled Study. |
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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention |
Condition |
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Intervention | Drug: 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. Other Names: Tube feed formula:(Vital AF 1.2 Cal(TM),Abbott,Columbus,OH)Other: Placebo and tube feed Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo. Other Names: Tube feed formula:(Vital AF 1.2 Cal(TM),Abbott,Columbus,OH) |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Not yet recruiting |
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Estimated Enrollment | 198 |
Estimated Completion Date | March 2015 |
Estimated Primary Completion Date | August 2014 |
Eligibility Criteria | 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Crissie DeSpirito, RN 502-852-0026 crissie.despirito@louisville.edu |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01477320 |
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Other Study ID Numbers | 11.0170 |
Has Data Monitoring Committee | Yes |
Information Provided By | University of Louisville |
Study Sponsor | Rodrigo Cavallazzi |
Collaborators | Abbott Nutrition University of Louisville |
Investigators | Principal Investigator: Rodrigo Cavallazzi, MD University of Louisville |
Verification Date | July 2013 |
Locations[ + expand ][ + ]
University of Louisville hospital | Louisville, Kentucky, United States, 40202 Contact: Crissie DeSpirito, RN | 502-852-0026 | crissie.despirito@louisville.eduPrincipal Investigator: Rodrigo Cavallazzi, MD Not yet recruiting |
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