Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000647932
Ethics application status
Approved
Date submitted
10/06/2011
Date registered
23/06/2011
Date last updated
23/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Administration of pantoprazole and its effects on gastric PH,inflammatory & anti inflammatory factors in critically ill patients.
Scientific title
A Comparative study of bolus & Continuous administration of pantoprazole on gastric PH and its effect on inflammatory & anti inflammatory cytokines(IL1,TNFa vs IL10,EGF) in critically ill patients.
Secondary ID [1] 262403 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric acidity 268020 0
Inflamatory & Anti inflamatory cytokines in gastric juice and blood 268021 0
Condition category
Condition code
Oral and Gastrointestinal 268153 268153 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 268154 268154 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Critically ill patients with gastric pH below 3,bolus Pantoprazole(80 mg/day,48 hours)
Arm 2:Critically ill patients with gastric pH below 3, continuous infusion Pantoprazole(80mg/day,48 hours)
Arm3:Critically ill patients with gastric pH below 3,continuous
infusion Ranitidin(150mg/day,48hours)
pH measure by a pH meter probe and litmus paper
Intervention code [1] 266706 0
Prevention
Intervention code [2] 266707 0
Treatment: Drugs
Intervention code [3] 266708 0
Treatment: Devices
Comparator / control treatment
Critically ill patients with gastric pH below 3,continuous
infusion Ranitidin(150mg/day,48hours)
Control group
Active

Outcomes
Primary outcome [1] 266899 0
Changes in inflamatory & anti inflamatory cytokines(IL1,TNFa vs IL10,EGF) in gastric juice, ELISA IMMUNOASSAY
Timepoint [1] 266899 0
0,12,24&48 hours after starting Administration of pantprazole or Ranitidine
Secondary outcome [1] 276582 0
Changes in inflamatory anti inflamatory cytokines(IL1,TNFa vs IL10,EGF) in plasma,ELISA IMMUNOASSAY
Timepoint [1] 276582 0
0,12,24&48 hours after starting Administration of pantprazole or Ranitidine

Eligibility
Key inclusion criteria
Inclusion Criteria :
1-Age>18
2-Clinical need for a nasogastric tube
3-Expectation of 48 hrs of “nothing by mouth” status
4-Baseline gastric pH <3.5
5-High risk patients for stress ulcer(one of these risk
factors)
patients with Coagulopathy disorders.
Ventilator dependant patients, shock, Respiratory failure, trauma
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1-History of peptic ulcer disease
2-Patients with zollinger Ellison
3-Recipients of H2 blockers & NSAIDS
4-Tube feeding
5-Creatinine>2 or Creatinine > %25 increase in base line
6-Abnormal LFT (3 times>base line)
7- Renal failure

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 3612 0
Iran, Islamic Republic Of
State/province [1] 3612 0

Funding & Sponsors
Funding source category [1] 267201 0
University
Name [1] 267201 0
Tehran university of medical sciences
Country [1] 267201 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tehran university of medical sciences
Address
16 AZAR AVE,Tehran university of medical sciences,Faculty of pharmacy,Tehran 1417614411
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 266271 0
None
Name [1] 266271 0
Address [1] 266271 0
Country [1] 266271 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269193 0
Pharmaceutical Sciences Research centre
Ethics committee address [1] 269193 0
16 AZAR AVE,, Faculty of Pharmacy,Pharmaceutical Sciences Research Center, Tehran 1417614411.
Ethics committee country [1] 269193 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 269193 0
Approval date [1] 269193 0
Ethics approval number [1] 269193 0
86-4-13:7

Summary
Brief summary
Cytokines have some roles in stress related mucosal damage (SRMD),some studies mentioned probable anti inflamatory effects of proton pump inhibitors(PPIs).
The primary purpose of this study is to find that if PPIs in critically ill patients can reduce inflamatory factors secreted in gastric juice in addition to increase the gastric pH?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32699 0
Address 32699 0
Country 32699 0
Phone 32699 0
Fax 32699 0
Email 32699 0
Contact person for public queries
Name 15946 0
Mojtahedzade,Mojtaba
Address 15946 0
16 AZAR AVE,Tehran university of medical sciences,faculty of pharmacy,Department of clinical pharmacy,Tehran 1417614411
Country 15946 0
Iran, Islamic Republic Of
Phone 15946 0
+98 912 1056032
Fax 15946 0
+982166954709
Email 15946 0
Mojtahed@sina.tums.ac.ir
Contact person for scientific queries
Name 6874 0
Mojtahedzade,Mojtaba
Address 6874 0
16 AZAR AVE,Tehran university of medical sciences,faculty of pharmacy,Department of clinical pharmacy,Tehran
1417614411
Country 6874 0
Iran, Islamic Republic Of
Phone 6874 0
+98 912 1056032
Fax 6874 0
Email 6874 0
Mojtahed@sina.tums.ac.ir

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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