A comparison of nasogastric pantoprazole suspension and intravenouse pantoprazole in prevention of peptic ulcer for critically ill patients with mechanical ventilation support: effects on 24-h intragastric pH.
The purpose of this randomized clinical trial is to compare the efficacy of pantoprazole for prevention of peptic ulcer when administered as a suspension in sodium bicarbonate solution versus the IV injection. 66 patients with age more than 18 years and with support of mechanical ventilation at least for 48 hours and nasogastric tube at medical and surgical ICUs of Rasoul -e-Akram Hospital are enrolled.Intragastric pH is monitored at baseline and on days 1 and 3 after beginning the treatment in all patients.33 patients ( group A)receive :pantoprazole 40 mg once daily intravenously and 33 patients(group B) receive: 25 cc of 2mg/ml simplified formulated pantoprazole suspension ( 50 mg pantoprazole) once daily nasogastrically and according to 75% bioavailability for suspension at last this dose equal to 40mg oral pantoprazole .All patients will receive their treatment regimen for at least 24 hours and up to 14 days depending on their survival, length of stay and removal of nasogastric tube.And if possible, the follow up will be done for28 days. For both groups of patients, blood samples are collected before the drug administration and in different times upto 24 hours afterward for measurement of pantoprazole concentration by high-performance liquid chromatography and estimation of pharmacokinetic values .The intragastric pH results and pharmacokinetic values,any episode of gastrointestinal bleeding after starting treatment and any probable drug side effects are recorded and statistical analysis is performed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015070220178N5
Registration date:2015-08-12, 1394/05/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-12, 1394/05/21
Registrant information
Name
Marjan Mokhtare
Name of organization / entity
Iran University of Medical sciences,Rasoul Akram Hospital,Colorectal Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 2845
Email address
mokhtare.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences,Rasoul Akram Hospital,Colorectal Research Center
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of nasogastric pantoprazole suspension and intravenouse pantoprazole in prevention of peptic ulcer for critically ill patients with mechanical ventilation support: effects on 24-h intragastric pH.
Public title
Efficacy of pantoprazole suspension for prevention of peptic ulcer.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Patients older than 18 years who are admitted to medical and surgical ICUs with support of mechanical ventilation at least for 48 hours and nasogastric tube .
Exclusion criteria:active gastrointestinal bleeding,allergic history to pantoprazole ,co-administeration of prokinetic and other acid reducing drugs,past history of gastric surgery,nasogastric tube intolerance,liver failure,pregnancy, lactation,unexpected intragastric pH<0.8 and/or >10.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
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
Iran University of Medical Sciences Ethics Committee
Street address
Iran University of Medical Sciences,West Shahid Hemmat Highway,Intersection of Chamran and Sheikh Fazlollah Noori,
City
Tehran
Postal code
Approval date
2015-06-30, 1394/04/09
Ethics committee reference number
IR.IUMS.REC.1394.26271
Health conditions studied
1
Description of health condition studied
peptic ulcer prevention
ICD-10 code
k27
ICD-10 code description
Peptic ulcer, site unspecified
Primary outcomes
1
Description
peptic ulcer prevention
Timepoint
basic ,first day,third day
Method of measurement
24 hours intragastric PH monitoring
Secondary outcomes
1
Description
gastrointestinal bleeding rate after treatment intervention
Timepoint
1,3 ,7,14 and 28 days after treatment intervention
Method of measurement
Data gathering sheet and nasogastric tube exam
2
Description
Drug adverse effect such as pneumonia rate
Timepoint
3 ,7, 14 and 28 days after treatment intervention
Method of measurement
Sign and symptom gathering sheet and chest x-ray
3
Description
frequency ofunderlying etiologic factore for mechanical ventilation support
Timepoint
at the begining of treatment
Method of measurement
Data gathering sheet
Intervention groups
1
Description
group A:pantoprazole, 40 mg intravenous once daily.The IV solution will be prepared by injecting 10 ml of 0.9% sodium chloride injection into the vial containing the lyophilized powder.This solution will be then further dilluted with 90 ml of sodium chloride injection,The reconstituted solution will be infused over a period of 15 minutes.
Category
Prevention
2
Description
group B: 25 cc of 2mg/ml simplified formulated pantoprazole suspension ( 50 mg pantoprazole) once daily nasogastrically and according to 75% bioavailability for suspension at last this dose equal to pantoprazole tablet 40mg.The pantoprazole suspension is prepared four hours before administration. Two 40-mg pantoprazole tablet is ground into a fine powder . The powder is transferred to a glass container, and rinsed twice with 10 mL of 4.2% (0.5 M) sodium bicarbonate solution. The container is closed and shaked for 10 minutes until a uniform suspension formed. The suspension is transferred to a 40-mL polypropylene syringe. The glass container is rinsed twice with 10 mL of 4.2% sodium bicarbonate solution again, and the suspension is added to the syringe. The total volume of the suspension is 40 mL, and the pantoprazole concentration is 2 mg/mL. The suspension is protected from light.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Colorectal Research Center, Rasoul Akram Hospital
Full name of responsible person
Marjan Mokhtare
Street address
Sattarkhan Street, Niayesh Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences,Rasoul Akram Hospital,Colorectal Research Center
Full name of responsible person
Shahram Agah
Street address
Sattarkhan Street, Niayesh Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences,Rasoul Akram Hospital,Colorectal Research Center
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
Colorectal Research Center, Rasoul Akram Hospital
Full name of responsible person
Marjan Mokhtare
Position
Gastroenterologist and Hepatologist, Assistant professor