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Effects of Enteral Nutrition on Stress Ulcer Hemorrage. Multicenter Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Kursat Gundogan, TC Erciyes University

Brief Summary:
Enteral nutrition can provides prophylaxis against stress ulcer bleeding in critically ill patients and there may be no need to use acid suppressing drugs for stress ulcer bleeding prophylaxis in these patients. Half of the patients on enteral nutrition will not receive any acid suppressing drugs while other half receives it. They will be followed for gastrointestinal bleeding.

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Admission to ICU
  • Expected to stay in ICU >24 hours
  • No contraindications to EN within the first 24 hours after admission to the intensive care unit

Exclusion Criteria:

  • Evidence of active GI bleeding during current hospitalization prior to study entry
  • Coagulopathy (PLT<50.000, INR>1.5, aPTT>2xcontrol)
  • Patients receiving acid suppressing drugs prior to admission
  • Pregnancy or lactation
  • History/documented gastric ulcer
  • Burn>30% body surface area
  • Head injury or increased intracranial pressure
  • Partial or complete gastrectomy
  • Shock
  • Multi-system trauma
  • Exposure to gastric irritant drugs
  • Patients not giving informed consent

Information from the National Library of Medicine

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


Contacts
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Contact: Kurat Gundogan, MD +90 352 207 6666 ext 21919 kgundogan@erciyes.edu.tr
Contact: Murat Sungur, MD +90 352 207 6666 ext 21912 msungur@erciyes.edu.tr

Locations
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Turkey
Erciyes University Medical School Recruiting
Kayseri, Turkey, 38039
Contact: Kudret Dogru, MD    +90 352 207 6666 ext 20000    kdogru@erciyes.edu.tr   
Contact: Emine Alp, MD    +90 352 207 6666 ext 20000    ealp@erciyes.edu.tr   
Sponsors and Collaborators
TC Erciyes University
Publications:

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Responsible Party: Kursat Gundogan, Associate Professor of Medicine and Surgery, TC Erciyes University
ClinicalTrials.gov Identifier: NCT03098537    
Other Study ID Numbers: 2016/427
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Ulcer
Pathologic Processes
Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action