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
Pantoprazole is a gastric acid pump inhibitor similar to omeprazole used as the sodium salt in the treatment of erosive esophagitis associated with gastroesophageal reflux disease and pathological hypersecretion associated with Zollinger-Ellison syndrome. Pantoprazole works as a restrictor of H/K ATPase. Thus it leads to a reduction of hydrochloric acid production in the stomach and the pH value of the gastric juice come rise, which leads to a reduction of aggressiveness of the gastric juice and thus to accelerate healing of gastric wall injuries.(as for example:SRMD)
Changes in inflammatory cytokines and inhibition of prostaglandin synthesis lead to reduced resistance of gastric mucosa to damaging factors.
Some studies performed on the role of cytokines in gastric pH and peptic ulcer disease are as following:
Increase of Helicobacter.Pylori in endoscopic studies was due to low mucosal concentrations of IL-8, IL-1a and high concentration of IL-13 and in another study increased concentration of TNF-a and IL-6 was associated with H.Pylori gastritis.
No relationship between IL-1B gene polymorphism and gastric secretion in younger healthy volunteers is seen.
Inhibitory potency of twice-a-day omeprazole on gastric acidity is enhanced by eradication of H.Pylori and is correlated to fall in gastric juice NH3.
Gastoesophageal reflux disease-associated esophagitis induces endogenous cytokine production (IL-6).
IL-8/STREM is an independent factor for the generation of peptic ulcer disease and might behave as an anti-inflammatory mediator in chronic gastritis.
The effect of HBD-2 in pathogenesis of gastritis may be through its function as immune and inflammatory mediator.
These results indicate that classic cytokines are important mediators associated with esophagitis and gastritis.

Experimental section:
Upon admission to the ICU all the patients who did need nasogastric tube and met the following inclusion criteria would be enrolled to intragastric pH – temp monitoring trial.
- 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.
- exclusion criteria
1. History of peptic ulcer disease, active G.I bleeding
2. Patients with zollinger Ellison
3. Recipient of H2 blockers & NSAIDs
4. Tube feeding
5. Creatinin>2 or Creatinine>25%increase in baseline
6. abnormal LFT (3 times > base line)
21 patients would be randomized in 3 groups.
Group A: receive pantoprazole 40 mg/BD
Group B: receive a bolous dose of pantoprazole 25mg stat and then 3 mg/hr
Group C( Control group): receive standard treatment
The study would last 64 hrs (two 24 hrs and a 16 hrs wash-out period between them, which patients intra gastric temp and pH monitored every 3hrs, with our intra gastric probe catheter simultaneously 5cc of gastric Juice is going to be obtained every 6hrs and pH shall be detected via pH meter. The level of inflammatory interleukins IL1, TNF? and anti inflammatory interleukins IL10, EGF of patient’s gastric juice with enzyme-link immunoassay in 2, 12, 24, 48, 64 hrs after admission of the patient two the ICU. To find out that is there any relation between intra gastric pH and temp and the levels of this inflammatory and anti inflammatory factors.
Endoscopy will be perform pre and post intervention for the patients to compare the degree of mucosal damage due to Stress between group (RMD)
Trial website
www.tums.ac.ir
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

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