Comparing the effectiveness of injectable pantoprazole, oral pantoprazole and injectable famotidine for stress ulcer prophylaxis in the intensive care unit.
Comparison of the effects of injectable famotidine - injectable pantoprazole - oral pantoprazole in the rate of gastric PH change in patients hospitalized in the intensive care unit, so that the drug regimen with the lowest cost is evaluated to achieve the desired effects.
Design
Phase II randomized clinical trial on 60 patients admitted to the intensive care unit. According to the simple random table, patients are placed in three parallel groups of injectable pantoprazole (20 patients), oral pantoprazole (20 patients) and injection famotidine (20 patients). On days 1, 3, 5, 7, the pH of the stomach of the patients is determined by laboratory digital pH meters and pH meter paper (Torrance paper has been approved by two people to prevent vision errors) 3 times on the said days. Also, CRP/Alb index is measured on day 0 and day 7.
Settings and conduct
The intensive care units of Sinai Hospital
Participants/Inclusion and exclusion criteria
Patients over 18 years of age admitted to the intensive care unit, who have a nasogastric tube and are indicated for the prevention of gastric ulcer, will be included in the study on the condition of signing an informed consent form. Patients with bariatric surgery, gastrectomy surgery, gastric ulcer or active bleeding of the gastrointestinal tract and gastric malignancy, and patients who have received PPI and H2 Blocker drugs in the last 5 days or whose gastric acid base is above 5, will be excluded from the study.
Intervention groups
Intravenous pantoprazole group 40 mg daily
Oral pantoprazole group 40 mg daily
Famotidine group 20 mg injection twice a day
Main outcome variables
Comparison of the effect of injectable famotidine - injectable pantoprazole - oral pantoprazole on the amount of gastric acidity change in patients admitted to the intensive care unit
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200322046833N3
Registration date:2024-01-04, 1402/10/14
Registration timing:registered_while_recruiting
Last update:2024-01-04, 1402/10/14
Update count:0
Registration date
2024-01-04, 1402/10/14
Registrant information
Name
Farhad Najmeddin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
f-najmeddin@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of injectable pantoprazole, oral pantoprazole and injectable famotidine for stress ulcer prophylaxis in the intensive care unit.
Public title
Comparing the effectiveness of injectable pantoprazole, oral pantoprazole and injectable famotidine for stress ulcer prophylaxis in the intensive care unit.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years of age hospitalized in the intensive care unit who have a nasogastric tube and are indicated for the prevention of peptic ulcer.
Sign the informed consent
Exclusion criteria:
Bariatric surgery
Gastrectomy surgery
Active gastrointestinal ulcer or gastrointestinal bleeding
Stomach malignancy
Patients who have received PPI and H2 Blocker drugs in the last 5 days
Patients whose gastric acid base is above 5
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into three parallel groups by simple random number table
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
Ethics Committee of Sina Hospital - Tehran University of Medical Sciences
Street address
Sina Hospital, Imam Khomeini St, Hasanabad Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2023-08-05, 1402/05/14
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1402.061
Health conditions studied
1
Description of health condition studied
gastric stress ulcer prophylaxes
ICD-10 code
K27
ICD-10 code description
Peptic ulcer, site unspecified
Primary outcomes
1
Description
Frequency of occurrence of pH less than 5 during the study
Timepoint
On day 1,3,5 and 7 stomach pH of patients is determined by digital laboratory pH meter and paper pH meter (to avoid the optical error of litmus paper, it is confirmed by two people), 3 times a day.
Method of measurement
about 10 cc of stomach contents are aspirated one hour after gavage and measured with digital laboratory pH meter and paper pH meter (to avoid the optical error of litmus paper, it is confirmed by two people).
Secondary outcomes
1
Description
Average changes of CRP/Alb - lymphocyte to neutrophil ratio - platelet to lymphocyte ratio on the first day compared to the seventh day in the group of injectable famotidine and injectable pantoprazole and oral pantoprazole in patients admitted to the intensive care unit. The number of days hospitalized in the intensive care unit in the group of injectable famotidine and injectable pantoprazole and oral pantoprazole in patients hospitalized in intensive care units. Mortality in the group of injectable famotidine and parenteral pantoprazole and oral pantoprazole in patients admitted to the intensive care unit.
Timepoint
The inflammatory index CRP/Alb is checked on day 0 and day 7. The time of discharge from the intensive care unit or the death of patients is recorded.
Method of measurement
The inflammatory index CRP/Alb is checked on day 0 and day 7. The time of discharge from the intensive care unit or the death of patients is recorded.
Intervention groups
1
Description
Intervention group: intravenous pantoprazole
Category
Prevention
2
Description
Intervention group: intravenous famotidine
Category
Prevention
3
Description
Intervention group: oral pantoprazole
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Farhad Najmeddin
Street address
Sina Hospital, Imam Khomeini St, Hasanabad Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
f-najmeddin@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhad Najmeddin
Street address
Sina Hospital, Imam Khomeini St, Hasanabad Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
f-najmeddin@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhad Najmeddin
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Sina Hospital, Imam Khomeini St, Hasanabad Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
f-najmeddin@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhad Najmeddin
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Sina Hospital, Imam Khomeini St, Hasanabad Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
f-najmeddin@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhad Najmeddin
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Sina Hospital, Imam Khomeini St, Hasanabad Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
f-najmeddin@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Clinical results will be published through an original article and All other data will be available on request
When the data will become available and for how long
Up to 5 years after publishing the clinical results
To whom data/document is available
Researchers and ethics committee
Under which criteria data/document could be used
Ethical evaluation and review articles without financial conflicts of interest.
From where data/document is obtainable
Responsible Researcher Dr Farhad Najmeddin by the following email f-najmeddin@tums.ac.ir
What processes are involved for a request to access data/document
Data will be available within 2 weeks after the email check. The email should include the Conflict of interest disclosure