Investigating and comparing the severity and prevalence of ventilator-induced pneumonia in patients taking famotidine and pantoprazole in the intensive care unit
To determine the effects of famotidine and pantoprazole on the incidence of ventilator-induced pneumonia in the intensive care unit.
Design
This prospective experimental study will be conducted as a randomized clinical trial. The study population in this study will be patients hospitalized in the intensive care unit of Tehran Bou-Ali Hospital in 1403 who use mechanical ventilation.
Settings and conduct
Eligible patients will be assigned to two treatment groups by a random block method of four by the attending physician. One group will be treated with a stress ulcer prophylaxis regimen with intravenous pantoprazole 40 mg daily and the second group with a stress ulcer prophylaxis regimen with intravenous famotidine 20 mg twice a day. Pneumonia assessment will also be based on the criteria provided by the ATS/IDSA and CDC guidelines.
Participants/Inclusion and exclusion criteria
The inclusion criteria for the study include the use of patients aged 18 to 80 years in intensive care units who have mechanical ventilation for at least 48 hours.
Patients with active pulmonary infection, patients with immunosuppression, patients with liver problems, renal (high creatinine levels), people with a history of sensitivity, and those with active gastrointestinal bleeding will not be included.
Intervention groups
One group will be treated with the stress ulcer prophylaxis regimen with intravenous pantoprazole 40 mg daily and the second group will be treated with the stress ulcer prophylaxis regimen with intravenous famotidine 20 mg twice daily.
Main outcome variables
Incidence of pneumonia, which is measured by the occurrence of infection and non-occurrence of pneumonia infection.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231220060484N2
Registration date:2024-04-09, 1403/01/21
Registration timing:prospective
Last update:2024-04-09, 1403/01/21
Update count:0
Registration date
2024-04-09, 1403/01/21
Registrant information
Name
Amirhossein Ghanbarzamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4406 9924
Email address
amirh.ghzamani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-11, 1403/02/22
Expected recruitment end date
2024-11-18, 1403/08/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating and comparing the severity and prevalence of ventilator-induced pneumonia in patients taking famotidine and pantoprazole in the intensive care unit
Public title
Investigating and comparing the severity and prevalence of ventilator-induced pneumonia in patients taking famotidine and pantoprazole in the intensive care unit
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
The inclusion criteria for the study of patients include the use of patients aged 18 to 80 years in intensive care units who have mechanical ventilation for at least 48 hours.
Exclusion criteria:
Patients with active pulmonary infection, patients with immunosuppression, patients with liver problems, renal problems (high creatinine levels), people with a history of sensitivity, and those with active gastrointestinal bleeding will not be included.
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups receiving Pantoprazole (A) and Famotidine (B). The permutations of the block will thus be BBAA-BAAB-BABA-ABBA-ABBAAB. Each block will be numbered from one to six, then a random number will be selected from one to six. Corresponding the extracted number of the target block will be extracted and according to its permutations, patients will be assigned to two groups of treatment Pantoprazole (A) and Famotidine (B) treatment group.
Selection of patients and allocating patients to study groups and drug interventions will be performed by the physician. Data extracted from each patient will be done by the researcher and based on the form.
Blinding (investigator's opinion)
Double blinded
Blinding description
The two study groups are placed according to the existing guidelines for stress ulcer prophylaxis. The patient will not know the type of prophylaxis regimen, and the researcher will not know the type of treatment received by the patients until the end of the sampling and decoding of the drugs. As a result, the study is done in a double-blind manner.
Placebo
Not used
Assignment
Parallel
Other design features
This experimental clinical trial study will be conducted on 124 patients (62 patients in each group) hospitalized in the special care department of BouAli Hospital in Tehran in 2024 who use mechanical ventilation. Considering the physical and physical conditions of the patients, the objectives of the study will be explained to the patient's companions or legal guardians and informed consent will be obtained from them. Patients eligible to enter the study will be selected as available and will be assigned to two treatment groups by a random block method of four. Patients will be assigned to two groups receiving pantoprazole (A) and famotidine (B) by random block method of four. The block permutations will thus be BBAA-BAAB-BABA-ABBA-ABAB-AABB. Each block will be numbered from 1 to 6, then a random number from 1 to 6 will be selected. One group will be treated with a stress ulcer prophylaxis regimen with intravenous pantoprazole 40 mg daily and the second group with a stress ulcer prophylaxis regimen with intravenous famotidine 20 mg twice a day. Corresponding to the extracted number of the desired block and according to its permutations, patients will be assigned to two treatment groups (A) pantoprazole drug and treatment group (B) famotidine drug. Selection of patients and allocation of patients to the studied groups and performed Medical interventions will be carried out by the attending physician. The data obtained from each patient will be extracted by the researcher based on the form. APACHE II score will be measured for the examined patients. Pneumonia diagnosis will also be based on the criteria provided by ATS/IDSA and CDC guidelines. The data will be entered into 27spss software and analyzed with descriptive statistics and independent t-tests, U-Man-Whitney, Chi-score, or Fisher's exact test at a significance level of 0.05.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Tehran medical sciences
Street address
No.99, Yakhchal street, Gholhak, Dr. Shariati
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2024-03-10, 1402/12/20
Ethics committee reference number
IR.IAU.PS.REC.1402.655
Health conditions studied
1
Description of health condition studied
ventilator-induced pneumonia
ICD-10 code
J95.851
ICD-10 code description
ventilator-associated pneumonia
Primary outcomes
1
Description
Pneumonia incidence is measured by the occurrence of infection or its non-occurrence.
Timepoint
Investigating the occurrence of pneumonia after 48 hours of hospitalization
Method of measurement
Qualitative measurement with CT scan or Chest X-ray criteria / Quantitative measurement with CPIS criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One group will be treated with stress ulcer prophylaxis regimen with intravenous pantoprazole 40 mg daily and the second group will be treated with stress ulcer prophylaxis regimen with intravenous famotidine 20 mg twice a day. Pneumonia diagnosis will also be based on the criteria provided by ATS/IDSA and CDC guidelines.
No.99, Yakhchal street, Dr. Shariati Avenue Tehran
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Email
Amirh.ghzamani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
Proportion provided by this source
1
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
Islamic Azad University
Full name of responsible person
Sanaz Omidi
Position
pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, Yasaman Alley, Yakhchal St, Shariati Av
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 2264 0051
Email
omidi.san@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Amirhossein Ghanbarzamani
Position
clinical pharmacist/ Intensive care unit fellowship
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.99, Yakhchal strteet, Dr. Shariati Avenue
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Email
Amirh.ghzamani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sanaz Omidi
Position
Pharmacy Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 2264 0056
Email
omidi.san@gmail.com
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The personal data of people is received and recorded confidentially and with their informed consent.
When the data will become available and for how long
Access is possible after the publication of the article.
To whom data/document is available
All researchers can access the data by searching the global databases after the publication of the article.
Under which criteria data/document could be used
No more information
From where data/document is obtainable
Applicants can refer to the Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran Medical Sciences, Islamic Azad University, Dr. Amirhossein Ghanbarzamani, or contact the researcher by sending an email to omidi.san@gmail.com
What processes are involved for a request to access data/document
Applicants can apply for research information by visiting the department or by contacting the e-mail address and telephone number as well as providing information on academic studies and the purpose of requesting the information. Applicants must commit themselves to mention the source. If the request is sent six months after the publication of the research information, there searcher will send the data to the requesting party by email within a week.