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

Enteral Nutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03098537
• Other study ID #: 2016/427
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2017
• Last updated: March 27, 2017
• Start date: August 1, 2016
• Est. completion date: December 1, 2017

Study information

• Verified date: March 2017
• Source: TC Erciyes University
• Contact: Kurat Gundogan, MD
• Phone: +90 352 207 6666
• Email: kgundogan[@]erciyes.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enteral Nutrition
• Gastro Intestinal Bleeding
• Gastrointestinal Hemorrhage
• Proton Pump Inhibitor
• Stress Ulcer Prophylaxis
• Ulcer

Intervention

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

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.

Locations

Country	Name	City	State
Turkey	Erciyes University Medical School	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (12)

Cook DJ, Fuller HD, Guyatt GH, Marshall JC, Leasa D, Hall R, Winton TL, Rutledge F, Todd TJ, Roy P, et al. Risk factors for gastrointestinal bleeding in critically ill patients. Canadian Critical Care Trials Group. N Engl J Med. 1994 Feb 10;330(6):377-81. — View Citation

Cook DJ, Reeve BK, Guyatt GH, Heyland DK, Griffith LE, Buckingham L, Tryba M. Stress ulcer prophylaxis in critically ill patients. Resolving discordant meta-analyses. JAMA. 1996 Jan 24-31;275(4):308-14. — View Citation

Cunningham R, Dale B, Undy B, Gaunt N. Proton pump inhibitors as a risk factor for Clostridium difficile diarrhoea. J Hosp Infect. 2003 Jul;54(3):243-5. — View Citation

Daley RJ, Rebuck JA, Welage LS, Rogers FB. Prevention of stress ulceration: current trends in critical care. Crit Care Med. 2004 Oct;32(10):2008-13. — View Citation

Dial S, Alrasadi K, Manoukian C, Huang A, Menzies D. Risk of Clostridium difficile diarrhea among hospital inpatients prescribed proton pump inhibitors: cohort and case-control studies. CMAJ. 2004 Jul 6;171(1):33-8. — View Citation

Ephgrave KS, Kleiman-Wexler RL, Adair CG. Enteral nutrients prevent stress ulceration and increase intragastric volume. Crit Care Med. 1990 Jun;18(6):621-4. — View Citation

Herzig SJ, Howell MD, Ngo LH, Marcantonio ER. Acid-suppressive medication use and the risk for hospital-acquired pneumonia. JAMA. 2009 May 27;301(20):2120-8. doi: 10.1001/jama.2009.722. — View Citation

Lin PC, Chang CH, Hsu PI, Tseng PL, Huang YB. The efficacy and safety of proton pump inhibitors vs histamine-2 receptor antagonists for stress ulcer bleeding prophylaxis among critical care patients: a meta-analysis. Crit Care Med. 2010 Apr;38(4):1197-205. doi: 10.1097/CCM.0b013e3181d69ccf. — View Citation

Pingleton SK, Hadzima SK. Enteral alimentation and gastrointestinal bleeding in mechanically ventilated patients. Crit Care Med. 1983 Jan;11(1):13-6. — View Citation

Pisegna JR. Pharmacology of acid suppression in the hospital setting: focus on proton pump inhibition. Crit Care Med. 2002 Jun;30(6 Suppl):S356-61. Review. — View Citation

Raff T, Germann G, Hartmann B. The value of early enteral nutrition in the prophylaxis of stress ulceration in the severely burned patient. Burns. 1997 Jun;23(4):313-8. — View Citation

Shorr LD, Sirinek KR, Page CP, Levine BA. The role of glucose in preventing stress gastric mucosal injury. J Surg Res. 1984 Apr;36(4):384-8. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GI bleeding	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.	Subjects will be followed from date of randomization until discharge from the ICU or cessation of enteral nutrition up to four weeks