NCT03098537

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

March 20, 2017

Last Update Submit

March 27, 2017

Conditions

Enteral NutritionGastro Intestinal BleedingStress Ulcer ProphylaxisProton Pump Inhibitor

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Enteral nutrion only

ACTIVE COMPARATOR
Other: enteral nutrition only

Enteral nutrion + proton pump inhibitor

OTHER
Drug: enteral nutrition + proton pump inhibitor

Interventions

enteral nutrition + proton pump inhibitorDRUG

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

Enteral nutrion + proton pump inhibitor
enteral nutrition onlyOTHER

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 only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Medical School

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

Related 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. doi: 10.1056/NEJM199402103300601.

    PMID: 8284001BACKGROUND

  • 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. doi: 10.1016/s0305-4179(97)89875-0.

    PMID: 9248640BACKGROUND

  • 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. doi: 10.1097/00003246-199006000-00009.

    PMID: 2111755BACKGROUND

  • 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. doi: 10.1016/0022-4804(84)90115-x.

    PMID: 6546772BACKGROUND

  • Pingleton SK, Hadzima SK. Enteral alimentation and gastrointestinal bleeding in mechanically ventilated patients. Crit Care Med. 1983 Jan;11(1):13-6. doi: 10.1097/00003246-198301000-00005.

    PMID: 6401236BACKGROUND

  • 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.

    PMID: 8544272BACKGROUND

  • 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. doi: 10.1097/01.ccm.0000142398.73762.20.

    PMID: 15483408BACKGROUND

  • 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. doi: 10.1097/00003246-200206001-00003.

    PMID: 12072661BACKGROUND

  • 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.

    PMID: 20173630BACKGROUND

  • 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.

    PMID: 19470989BACKGROUND

  • 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. doi: 10.1016/s0195-6701(03)00088-4.

    PMID: 12855243BACKGROUND

  • 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. doi: 10.1503/cmaj.1040876.

    PMID: 15238493BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Enteral NutritionProton Pump Inhibitors

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition TherapyEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Kurat Gundogan, MD

CONTACT

+90 352 207 6666kgundogan@erciyes.edu.tr

Murat Sungur, MD

CONTACT

+90 352 207 6666msungur@erciyes.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Surgery

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 31, 2017

Study Start

August 1, 2016

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

March 31, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)