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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

prevention of stress related mucosal damage

Condition category

Condition code

Other

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]

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]

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]

It is measured 72 hours after treatment

Secondary outcome [1]

reliability of probe in monitoring intragastric pH and temprature.measurement of biomarkers(IL1, IL10, TNF a, ECF)

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

0098

Recruitment outside Australia

Country [1]

Iran, Islamic Republic Of

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Tehran university of medical sciences

Address [1]

Engelab street,tehran

Country [1]

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]

Commercial sector/Industry

Name [1]

cobel daru

Address [1]

Alvand street,Argentine square,Tehran

Country [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Ata Mahmoodpoor

Address

NO:423,Arman residential tower,Ashrafi esfahani highway,Tehran

Country

Iran, Islamic Republic Of

Phone

00989141160888

Fax

[email protected]

Contact person for scientific queries

Name

Ata Mahmoodpoor

Address

NO:423,Arman residential tower,Ashrafi esfahani highway,Tehran

Country

Iran, Islamic Republic Of

Phone

00989141160888

Fax

[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.

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