Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000197336
Ethics application status
Approved
Date submitted
13/02/2008
Date registered
14/04/2008
Date last updated
17/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reliability of Intragastric pH probe catheter equipped with temperature sensor for minute to minute monitoring in critically ill patients
Scientific title
Reliability of Intragastric pH probe catheter equipped with temperature sensor for minute to minute monitoring in critically ill patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress related mucosal damage 2830 0
prevention of stress related mucosal damage 2831 0
Condition category
Condition code
Other 2964 2964 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
panntoprazol,
Group A:40mg/12 Hours IV(Intravenous) for 3 days
Group B:25 mg IV(Intravenous) stat then 3 mg/hour for 3 days
Intervention code [1] 2564 0
Prevention
Comparator / control treatment
active control,standard treatment consist of ranitidin 50 mg/8 Hours Intravenously for 3 days
Control group
Active

Outcomes
Primary outcome [1] 3915 0
Intragastric catether,biomarkers(Interleukin10, Interleukin1,Tumor Necrosis Factora,Epidermal Growth Factor).
Evaluation the antiinflammatory effects of pantoprazol in prevention of stress related mucosal damage
Timepoint [1] 3915 0
It is measured 72 hours after treatment
Secondary outcome [1] 6471 0
reliability of probe in monitoring intragastric pH and temprature.measurement of biomarkers(IL1, IL10, TNF a, ECF)
Timepoint [1] 6471 0
It is measured 72 hours after intervention

Eligibility
Key inclusion criteria
1. Age>18
2. Base line intra gastric pH<3.5
3. High risk patients
a. patients with Coagulopathy disorders.
b. Ventilator dependant patients, shock, respiratory failure, trauma, sepsis
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of peptic ulcer disease, active G.I bleeding
2. Patients with zollinger Ellison
3. Recipient of H2 blockers & Non steroidal antiinflammatory drugs
4. Tube feeding
5. Creatinin>2 or Creatinine>25%increase in baseline
6. abnormal Liver function tests (3 times > base line)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization by using a randomization table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
21
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 787 0
0098
Recruitment outside Australia
Country [1] 795 0
Iran, Islamic Republic Of
State/province [1] 795 0

Funding & Sponsors
Funding source category [1] 3150 0
University
Name [1] 3150 0
Tehran university of medical sciences
Country [1] 3150 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tehran university of medical sciences
Address
Engelab street,Tehran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 2826 0
Commercial sector/Industry
Name [1] 2826 0
cobel daru
Address [1] 2826 0
Alvand street,Argentine square,Tehran
Country [1] 2826 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28372 0
Address 28372 0
Country 28372 0
Phone 28372 0
Fax 28372 0
Email 28372 0
Contact person for public queries
Name 11529 0
Ata Mahmoodpoor
Address 11529 0
NO:423,Arman residential tower,Ashrafi esfahani highway,Tehran
Country 11529 0
Iran, Islamic Republic Of
Phone 11529 0
00989141160888
Fax 11529 0
Email 11529 0
[email protected]
Contact person for scientific queries
Name 2457 0
Ata Mahmoodpoor
Address 2457 0
NO:423,Arman residential tower,Ashrafi esfahani highway,Tehran
Country 2457 0
Iran, Islamic Republic Of
Phone 2457 0
00989141160888
Fax 2457 0
Email 2457 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.