Stress related mucosal disease is common in intensive care unit. The prevention of gastrointestinal bleeding with the use of gastric acid-lowering agents leads to a reduction in major bleeding in patients.This study is designed to evaluate the effect of Laboratory prepared powder for suspension of Omeprazole on the gastric pH in critically ill patients. Thirty patients above sixteen years old with nasogastric tube in place and at least one additional risk factor for upper gastrointestinal bleeding were included in the study. The patients with active gastrointestinal bleeding, high dose of corticosteroids and Hypersensitivity to omeprazole were excluded from this study.The patients were treated with prophylaxis of suspension of omeprazole for at least fourteen days. Gastric aspirates were sampled via gavage syringe before and 2 hours after the administration of the drug. The patients gastric pH was measured and evaluated via pH-meter.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062120592N6
Registration date:2016-08-09, 1395/05/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-09, 1395/05/19
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9944
Email address
iran.criticalcare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences، Faculty of Pharmacy
Expected recruitment start date
2015-07-01, 1394/04/10
Expected recruitment end date
2016-05-30, 1395/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of prepared powder for Omeprazole suspension on gastric pH of ICU patients
Public title
The effect of Omeprazole suspension on gastric pH of ICU patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age of ≥16 yrs of age; anticipated stay of ≥72 hrs in ICU; required mechanical ventilation more than 48 hrs; APACHE II score ≥11; have a nasogastric or orogastric tube in place; have at least one additional risk factor for upper GI bleeding Exclusion criteria: status of no CPR; delay of >48 hrs from time of initial eligibility; history of gastric surgery; allergy to omeprazole; active GI bleeding; significant risk of swallowing blood; admission for upper GI surgery; known upper GI Lesions that might bleed; inability to take a suspension by nasogastric tube;end-stage liver disease
Age
From 16 years old to 95 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
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
Shahid Beheshti University of Medical science,faculty of Pharmacy
Street address
Valiasr Niayesh crossing,shahid beheshti university
City
Tehran
Postal code
14155-6153
Approval date
2014-01-26, 1392/11/06
Ethics committee reference number
SBMU.REC.1392.614
Health conditions studied
1
Description of health condition studied
erosion (acute) of stomach
ICD-10 code
k25
ICD-10 code description
Gastric ulcer
Primary outcomes
1
Description
mean gastric pH
Timepoint
before and 1-2.5 hrs after drug administration
Method of measurement
pH meter
Secondary outcomes
1
Description
active upper GI bleeding
Timepoint
every day up to 14 days
Method of measurement
Gastroccult test
Intervention groups
1
Description
patients for prophylaxis treated with omeprazol suspension (40mg)every day via nasogastric tube for 14 days. Gastric aspirates were sampled before(empty stomach) and 1.5-2 hours after administration of the drug.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari National Research Institute of Tuberculosis and Lung Disease
Full name of responsible person
Doctor seyed mohammadreza Hashemian
Street address
Masih Daneshvari hospital, Poorebtehaj St., Darabad, Niavaran Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Fanak Fahimi
Street address
No. 2660, Vali-e-Asr Ave., Tehran 1991953381, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sceinces,Faculty of pharmacy
Full name of responsible person
Doctor Fanak Fahimi
Position
Doctor of Pharmacy
Other areas of specialty/work
Street address
Niayesh-Valiasr crossing, Faculty of pharmacy
City
Tehran
Postal code
14155-6153
Phone
+98 21 8820 0118
Fax
+98 88665250
Email
fanakfahimi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Faculty of pharmacy
Full name of responsible person
Doctor Farzaneh Dastan
Position
Clinical Pharmacist
Other areas of specialty/work
Street address
Department of Clinical pharmacy, 3rd floor, Faculty of pharmacy, Niayesh-Valiasr crossing
City
Tehran
Postal code
14155-6153
Phone
+98 21 8820 0118
Fax
+98 88665250
Email
f_dastan@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti Universtity of Medical Sciences, Faculty of pharmacy
Full name of responsible person
Behnaz Arabpanahan
Position
student of pharm D
Other areas of specialty/work
Street address
Niayesh-Valiasr crossing, Faculty of pharmacy
City
Tehran
Postal code
Phone
00
Fax
Email
behnaz_saturn@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)