]>
IRCT20231220060484N2 IRCT 2024-04-09 Islamic Azad University Investigating and comparing the severity and prevalence of ventilator-induced pneumonia in patients taking famotidine and pantoprazole in the intensive care unit Investigating and comparing the severity and prevalence of ventilator-induced pneumonia in patients taking famotidine and pantoprazole in the intensive care unit 2024-05-11 anticipated 124 Complete https://irct.ir/trial/75899 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Screening, 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, 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 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. 3 ventilator-induced pneumonia. 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.. Yes - There is a plan to make this available What will be shared: The personal data of people is received and recorded confidentially and with their informed consent. When: Access is possible after the publication of the article. To whom: All researchers can access the data by searching the global databases after the publication of the article. Conditions: No more information Where to obtain: 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 How to obtain: 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. Comments:
public Sanaz Omidi
No 99, Yasaman Alley, Yakhchal St, Shariati Av
Tehran Iran (Islamic Republic of) 193956466 +98 21 2264 0051 omidi.san@gmail.com Islamic Azad University scientific Dr. Amirhossein Ghanbarzamani
No.99, Yakhchal strteet, Dr. Shariati Avenue
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 0056 Amirh.ghzamani@gmail.com Islamic Azad University Iran (Islamic Republic of) 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. 18 years 80 years Both 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. J95.851 ventilator-associated pneumonia Diagnosis 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. 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. Islamic Azad University Approved 2024-03-10 Ethics committee of Islamic Azad University of Tehran medical sciences No.99, Yakhchal street, Gholhak, Dr. Shariati Tehran Tehran Iran (Islamic Republic of)