Objective: The comparison of ranitidine and pantoprazole in prevention of stress ulcer in ICU.
Design: Double blind clinical trial
Population: 92 people from traumatic patients (multiple trauma and head trauma) who were admitted in ICU .
Inclusion criteria: patients who required mechanical ventilation and were admitted to the ICU, aged more than 18 years old, with APACHE SCORE II less than 25. Exclusion criteria: history of GI bleeding, liver or kidney insufficiency.
In control group,(ranitidine gruop),Amp ranitidine will prescribe 50mg twice daily; and in intervention group(pantoprazole);Amp pantoprazole will prescribe 40mg once daily. The efficacy of each drug was measured by the gastric secretion PH.
Immediately after admission of the patient to the ICU, prophylaxis will begin and before using the first dosage of prophylactic drug, the gastric PH will measure 8 hours after using the first dosage of drug the PH will measure again and after that the gastric Ph will measure every 8 hours in two next days. Primary outcome is the level of gastric PH and the secondary one is GI bleeding.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104134578N2
Registration date:2011-05-08, 1390/02/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-05-08, 1390/02/18
Registrant information
Name
Farshid Rahimibashar
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 811264002151
Email address
f.rahimi@umsh.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2011-02-20, 1389/12/01
Expected recruitment end date
2011-06-20, 1390/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of ranitidine and pantoprazole in prevention of stress ulcer in ICU
Public title
Ranitidine and pantoprazole in prevention of stress ulcer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients who required mechanical ventilation, Age more than 18 years old, Admission to the ICU, APACHE SCORE II less than 25, Admission at least 24 hour in ICU, Patients with suctionable secretion, No GI bleeding at the beginning of study
Exclusion criteria: History of GI bleeding, liver or kidney insufficiency, History of corticosteroids or NSAIDs usage, Gastric PH more than 4 before beginning of prophylaxis
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University Of Medical Sciences
Street address
Mahdiye Street, Hamedan University Of Medical Sciences
City
Hamedan
Postal code
Approval date
2011-04-07, 1390/01/18
Ethics committee reference number
16/35/9/20/پ/د
Health conditions studied
1
Description of health condition studied
stress ulcer
ICD-10 code
K25
ICD-10 code description
Gastric ulcer
Primary outcomes
1
Description
Gastric PH
Timepoint
Before intervention, every 8 houres after intervention for two next days
Method of measurement
The level of gastric PH which is measured by AZ8685 PH metery instrument
Secondary outcomes
1
Description
GI bleeding
Timepoint
Daily
Method of measurement
Evaluating the secretion which lavaged from the patient NG tube to the end of admission in the ICU
Intervention groups
1
Description
In intervention group Pantoprazol 40 mg once a day will infuse till to end of patient admission.
Category
Prevention
2
Description
In control group Ranitidine 50 mg twice a day will infuse till to end of patient admission.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Farshid Rahimi Bashar
Street address
BESAT Hospital, General ICU, Motahhari Avenue_Resalat square
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences-vice chancellor for research
Full name of responsible person
Ali GHaleiha
Street address
Mahdiye Street, Hamedan University Of Medical Sciences
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences-vice chancellor for research
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farshid Rahimi Bashar
Position
Assistant Professor/Intensive care fellowship
Other areas of specialty/work
Street address
Mahdiye Street, Hamedan University Of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 1827 6295
Fax
Email
fr_rahimibashar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farshid Rahimi Bashar
Position
Assistant Professor/Intensive care fellowship
Other areas of specialty/work
Street address
Mahdiye Street, Hamedan University Of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 1827 6295
Fax
Email
fr_rahimibashar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)