The goals of this single center, open labeled, randomized, clinical trial are comparing efficacy and safety of enteral nutrition with and without ranitidine on prevention of gastric ulcer in critically ill patients. Critically ill patients with indication of gastric ulcer prophylaxis and without contraindication for enteral feeding who are hospitalized for at least for 7 days in ICU will be included. Patients with active gastric ulcer or bleeding, enteral nutrition intolerance, coagulopathy and head trauma will be excluded. 50 patients with inclusions will be recruited based on the simple randomization method in groups A or B. Ranitidine (50 mg every 8 hours as slow intravenous injection) plus enteral nutrition for 7 days will be considered for patients in group A. Patients in group B will be receive only enteral nutrition during the study period. During the stduy patients will be monitored for gastrointestinal complications including enteral feeding intolerance, coffe ground secretions fron tube feeding, melena and hematemesis. Also patients will be assessed for episodes of aspiration pneumonia and airhead. Finally efficacy and safety of enteral nutrition with and without ranitidine will be compared in critically ill patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604213449N21
Registration date:2016-05-30, 1395/03/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-30, 1395/03/10
Registrant information
Name
Hossein Khalili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4715
Email address
khalilih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing efficacy and safety of enteral nutrition with and without ranitidine in prevention of gastric ulcer in critically ill patients
Public title
Enteral nutrition and gastric ulcer in critically ill patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Critically ill adult patients with indication of gastric ulcer prophylaxis without contraindication for enteral nutrition will be recruited.
Exclusion criteria: Patients with history of active gastric ulcer in month before inclusion; gastric bleeding in time of hospitalization; coagulopathy; enteral feeding intolerance; severe burn; head trauma; increased intracranial pressure
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
4th floor, No. 23, Poursina Street, Keshavarz Blvd., Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2016-05-14, 1395/02/25
Ethics committee reference number
IR.TUMS.REC.1395.2592
Health conditions studied
1
Description of health condition studied
Gastric Ulcer
ICD-10 code
K25
ICD-10 code description
Stress Induced Gastric Ulcer
Primary outcomes
1
Description
Stress induced gastric ulcer
Timepoint
At baseline and daily for 7 days
Method of measurement
Evaluation of gastrointestinal symptoms including gastric intolerance, coffe ground secretions from tube feeding, melena and hematemesis
Secondary outcomes
1
Description
Complications of gastric acid suppressant agents
Timepoint
At baseline and daily for 7 days
Method of measurement
Evaluation of patients for pneumonia and diarrehea
Intervention groups
1
Description
Intervention group: Enteral feeding as 50 ml at beginning and then increasing 50 ml every 3 hours up to 200 ml every 3 hours.
Category
Prevention
2
Description
Control group: Enteral feeding (same as the intervention group) plus ranitidine amp, 50 mg every 8 hours as slow intravenous injection for 7 days.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Hossein Khalili
Street address
General ICU, Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Masoud Yunesian
Street address
Ghods Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharm. D
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6119 2112
Fax
Email
khalilih@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharm. D
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6119 2112
Fax
Email
khalilih@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharrm. D
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6119 2112
Fax
Email
khalilih@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)