Effects of Enteral Nutrition on Stress Ulcer Hemorrage. Multicenter Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT03098537|
Recruitment Status : Unknown
Verified March 2017 by Kursat Gundogan, TC Erciyes University.
Recruitment status was: Recruiting
First Posted : March 31, 2017
Last Update Posted : March 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Enteral Nutrition Gastro Intestinal Bleeding Stress Ulcer Prophylaxis Proton Pump Inhibitor||Drug: enteral nutrition + proton pump inhibitor Other: enteral nutrition only||Not Applicable|
Mucosal erosions can occur on luminal surface of stomach in approximately 75-100% patients during the first 24 hours of intensive care unit admission. These erosions often cause bleeding with penetrating superficial capillaries. Clinically significant bleeding (Significant decrease in blood pressure or decrease in hemoglobin level of more than 2 g / dL) appears to be less than 5% in ICU patients.
Enteral nutrition (EN) has protective effects against stress ulcer bleeding by neutralizing the acidic pH in the stomach lumen, providing a structural and functional integrity of the mucosal surface and trophic effect on the GI mucosa. These effects have been shown in some studies. The above-mentioned studies are inadequate for clinicians to make suggestions for relation between enteral nutrition and stress ulcer hemorrhage.
The risk factors for stress ulcer hemorrhage are mechanical ventilation, coagulopathy and burns.
Proton pump inhibitors (PPI) and histamine receptor blockers (H2RB) are the main drugs used for stress ulcer bleeding prophylaxis.
Studies have shown that 90% of patients admitted to intensive care units receive prophylaxis for stress ulcer bleeding.
Drugs (H2RB, PPI) used for prophylaxis against stress ulcer bleeding have some undesirable harmful effects in critical illnesses. These drugs, which suppress gastric acid secretion, can cause hospital-associated pneumonia and Clostridium difficile enterocolitis.
The studies, for clinical proposals are generally performed in the 1980s and early 1990s. Oral intake was stopped in most of the critically ill patients and early enteral nutrition was not widely used at the time of these major studies performed. Patients who are receiving EN have been shown to develop less stress ulcer bleeding in some studies. In a limited number of animal studies, enteral feeding has been shown to protect stress-related mucosal damage in the gastric mucosa.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Enteral Nutrition on Stress Ulcer Hemorrage. Multicenter Randomized Controlled|
|Actual Study Start Date :||August 1, 2016|
|Estimated Primary Completion Date :||August 1, 2017|
|Estimated Study Completion Date :||December 1, 2017|
|Active Comparator: Enteral nutrion only||
Other: enteral nutrition only
Critically ill patients receiving any form of enteral nutrition will be included into the study. The patients will be randomized either enteral nutrition only group or enteral nutrition and proton pump inhibitors group. This group will receive only enteral nutrition.
|Enteral nutrion + proton pump inhibitor||
Drug: enteral nutrition + proton pump inhibitor
Critically ill patients receiving any form of enteral nutrition will be included into the study. The patients will be randomized either enteral nutrition only group or enteral nutrition and proton pump inhibitors group. This group will receive enteral nutrition and proton pump inhibitor
- GI bleeding [ Time Frame: Subjects will be followed from date of randomization until discharge from the ICU or cessation of enteral nutrition up to four weeks ]
Overt GI bleeding (presence of coffee ground emesis hematemesis, melena or hematochezia.
Significant GI bleeding, defined by 3-point decrease in hematocrit within 24 hours accompanied by overt GI bleeding or by an unexplained 6-point decrease in hematocrit during any 48 hour period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098537
|Contact: Kurat Gundogan, MD||+90 352 207 6666 ext email@example.com|
|Contact: Murat Sungur, MD||+90 352 207 6666 ext firstname.lastname@example.org|