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IRCT20230724058907N1 IRCT 2023-12-11 Ahvaz University of Medical Sciences Evaluation of nebulized heparin efficacy in acute respiratory distress syndrome Evaluation of nebulized heparin efficacy in pediatric patients with acute respiratory distress syndrome 2023-12-22 anticipated 66 Complete https://irct.ir/trial/73663 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this part "www.sealedenvelope.com" will be used to create random blocks to assign patients into groups and as a result a sequence of four blocks will be made. Considering that we have two groups in this study, our blocks of four can be as follows: AABB, ABAB, BABA, BBAA, BAAB, ABBA where A and B represent our groups. Then these six blocks will be numbered, and samples will be taken from these six blocks by replacement method. These blocks will then be put together to form our randomization sequence, Blinding description: The study will be done in a double-blind method.Neither the patient nor the doctor know how to be placed in the groups. To consider the age of the patients and the usual condition of consciousness in the ICU, it can be claimed none of them are aware of the drugs they are receiving. Because of the impossibility of making a placebo, this study will be done in a double blind manner in two intervention ( heparin nebulize) and placebo (Distilled water nebulize) groups. It will be done completely randomly by a person outside the research team who has no interference in the collection and analysis of data. 3 Acute respiratory distress syndrome. Intervention 1: Intervention group with nebulized heparin 5000 unit per 1 milliliter Sina darou (preservative free) with dose100 Unit per kilogram of body weight every 12hours for 7 days. Intervention 2: Control or placebo group with nebulized distilled water Caspian company 0.5 milliliter per kilogram of body weight every 12hours for 7 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Its release schedule is not yet known.
public Farzaneh Hematian
Abuzar Children's Educational and Therapeutic Hospital, Ahvaz
Ahvaz Iran (Islamic Republic of) 61635931 +98 61 3444 9003 minagarfatima@gmail.com Ahvaz University of Medical Sciences scientific Farzaneh Hematian
Parastar (Tohid) Ave., Chahrshir, Ahvaz, Khozestan, Iran
Ahvaz Iran (Islamic Republic of) 6163614175 +98 61 3444 9003 farzanehematian@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Children older than one month to 18 years old The underlying disease of acute respiratory distress syndrome Patients under mechanical ventilation for more than 48 hours with Pao2/Fio2<300 Patients who are expected to undergo invasive ventilation in the next 24 hours In CXR, bilateral pulmonary infiltration can be seen (5cmH2O PEEP>) 1 month 18 years Both History of allergy to heparin Bleeding history in the last 3 months History of any bleeding and coagulation disorders History of cerebral hemorrhage in the last year Uncontrolled active bleeding Simultaneous use of antiplatelet, anticoagulant and thrombolytic drugs Unwillingness to participate in the study J80 Acute respiratory distress syndrome Treatment - Drugs Treatment - Drugs Intervention group with nebulized heparin 5000 unit per 1 milliliter Sina darou (preservative free) with dose100 Unit per kilogram of body weight every 12hours for 7 days Control or placebo group with nebulized distilled water Caspian company 0.5 milliliter per kilogram of body weight every 12hours for 7 days Severity of acute respiratory distress syndrome. Timepoint: Time to enter the study or 0, 3, 5 and 7 days. Method of measurement: Pediatric acute respiratory distress syndrome criteria. Oxygen saturation with palse oximetry to fraction of inspired oxygen ratio. Timepoint: Time to enter the study or 0, 3, 5 and 7 days. Method of measurement: Pulse oximetry and mechanical ventilator. Arterial oxygen pressure by arterial blood gas to fraction of inspired oxygen ratio. Timepoint: Time to enter the study or 0, 3, 5 and 7 days. Method of measurement: Blood sample and mechanical ventilator. Oxigen saturation index ( fraction of inspired oxygen *mean airway pressure*100 ) to oxygen saturation by palse oximetry ratio. Timepoint: Time to enter the study or 0, 3, 5 and 7 days. Method of measurement: Pulse oximetry and mechanical ventilator. Oxygenation index (fraction of inspired oxygen *mean airway pressure*100) to oxygen saturation by arterial blood gas ratio. Timepoint: Time to enter the study or 0, 3, 5 and 7 days. Method of measurement: Blood sample and mechanical ventilator. Number of days required mechanical ventilation. Timepoint: Time to enter the study to discharge. Method of measurement: Patient file. Length of stay in Intensive Care Unit. Timepoint: Time to enter the study to discharge. Method of measurement: Patient file. Adverse effect. Timepoint: Full time of study. Method of measurement: Patient file and tests. Ahvaz University of Medical Sciences Approved 2023-07-15 Ethics committee of Ahvaz University of Medical Sciences Ground floor, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz , Iran. Ahvaz Khouzestan Iran (Islamic Republic of)