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IRCT20190522043672N1 IRCT 2020-01-18 Mashhad University of Medical Sciences Prevention of gastrointestinal bleeding and ventilator-associated pneumonia in children under mechanical ventilation. A clinical trial to compare the effects of ranitidine, pantoprazole, and sucralfate on the prevention of gastrointestinal bleeding and ventilator-associated pneumonia in children under mechanical ventilation. 2020-02-20 anticipated 87 Complete https://irct.ir/trial/39973 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The subjects will be randomly assigned into three groups of 29 patients with blocks of 2, 4 and 6 using randomization method. A noninvolved researcher will determine the random assignment sequencing in sample selection based on a statistical analysis system (SAS), computer software. Sequentially numbered sealed opaque envelopes will be used to conceal the sequencing. Accordingly, the participants were given codes and assigned into the intervention and control groups, Blinding description: The children under mechanical ventilation for more than 48 hours at the pediatric intensive care unit in Doctor Sheikh and Akbar Children's hospitals are selected in this study. In this double-blind study, sequentially numbered sealed opaque envelopes will be used to conceal the sequencing. The clinical care and those who are responsible for data collection are blind to the patients groups and the type of drugs. 2 Condition 1: Gastrointestinal bleeding. Condition 2: Ventilator-associated pneumonia. Intervention 1: Intervention group 1: Who will receive 4 mg/kg/day of intravenous ranitidine 3 times per day. Intervention 2: Intervention group 2: Who will receive 1 mg/kg/day of intravenous pantoprazole 2 times per day. Intervention 3: Intervention group 3: Who will receive 60 mg/kg/day of oral sucralfate 4 times per day. Yes - There is a plan to make this available What will be shared: The total data to be included are the primary and secondary effects to be shared. When: 6 months after printing results To whom: Our data will only be available to researchers working in science center and university. Conditions: Our data will be available for scholars working in science center and university. Where to obtain: Majid Sezavar provides the analysis code to the applicants via email: sezavardm@mums.ac.ir How to obtain: Applicants can respond to the email of the respondent and receive a response within a week Comments:
public Majid Sezavar
Akbar Children's Hospital, Shahid Kaveh 14, Shahid Kaveh Boulevard
Mashhad Iran (Islamic Republic of) 9173595100 +98 51 3870 9225 sezavardm@mums.ac.ir Mashhad University of Medical Sciences scientific Majid Sezavar
Akbar Children's Hospital, Shahid Kaveh 14, Shahid Kaveh Boulevard
Mashhad Iran (Islamic Republic of) 9173595100 +98 51 3870 9225 sezavardm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) The patients admitted to the pediatric care unit who have been under ventilation for at least 48 hours. 1 month 18 years Both Hospital stay or mechanical ventilation less than 48 hours Gastrointestinal bleeding before the onset of the treatment, Ventilator-associated pneumonia before the onset of the treatment T47.8 J84.9 Other agents primarily affecting the gastrointestinal system Interstitial pulmonary disease, unspecified Prevention Prevention Prevention Intervention group 1: Who will receive 4 mg/kg/day of intravenous ranitidine 3 times per day. Intervention group 2: Who will receive 1 mg/kg/day of intravenous pantoprazole 2 times per day. Intervention group 3: Who will receive 60 mg/kg/day of oral sucralfate 4 times per day. The rate of ventilator-associated pneumonia. Timepoint: 48 hours after intervention. Method of measurement: chest radiograghy. The rate of gastrointestinal bleeding. Timepoint: 48 hours after intervention. Method of measurement: Blood in stool and vomit. Upper airway colonization. Timepoint: 48 hours after intervention. Method of measurement: Microbiological culture. Hospital stay in the intensive care unit. Timepoint: After intervention. Method of measurement: Questionnaire. The rate of mortality. Timepoint: After intervention. Method of measurement: Questionnaire. Mashhad University of Medical Sciences Approved 2019-05-28 Ethics Committee of Mashhad University of Medical Sciences Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)