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

Not Applicable

• Conditions: Enteral Nutrition; Gastro Intestinal Bleeding; Stress Ulcer Prophylaxis; Proton Pump Inhibitor
• Interventions: Other: enteral nutrition only; Drug: enteral nutrition + proton pump inhibitor

• Registration Number: NCT03098537
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-08-01
• Status Verified: 2017-03
• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-27
• Last Update Submitted: 2017-03-27
• Study First Posted: 2017-03-31
• Last Update Posted: 2017-03-31
• Primary Completion: 2017-08-01
• Study Completion: 2017-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enteral nutrion only	enteral nutrition only	-
Enteral nutrion + proton pump inhibitor	enteral nutrition + proton pump inhibitor	-

Primary Outcome Measures

Name	Time	Method
GI bleeding	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.

Trial Locations

Locations (1)

Erciyes University Medical School; 🇹🇷 Kayseri, Turkey