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IRCT20170608034390N18 IRCT 2025-05-25 Shahid Beheshti University of Medical Sciences Evaluating the efficacy of eicosapentaenoic acid in patients with acute respiratory distress syndrome Evaluating the efficacy of eicosapentaenoic acid in patients with acute respiratory distress syndrome: A Randomized Controlled Trial. 2025-06-10 anticipated 80 Complete https://irct.ir/trial/79489 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will randomly divide the participants into two groups of the same size of 40 participants (80 patients in total), to ensure the same distribution of volunteers in the two groups, the block randomization method will be used. 10 blocks, each block including 8 participants randomly and equally distributed in each block, will be used for randomization using the block randomization service of the online software www.sealedenvelope.com, Blinding description: Participants, healthcare providers, investigator, outcome assessors and data analyst and quality controller are all blinded. The preparation of the drug or placebo inside the syringe will be done by a clean room expert in the hospital who is not part of the research team, and based on the block randomization table, the syringes will be prepared and delivered to the researchers with a unique code. 3 Acute respiratory distress syndrome. Intervention 1: Intervention group: The intervention group will receive 6 grams of eicosapentaenoic acid daily for 1 week as an add-on treatment. Intervention 2: Control group: In this group, 6 grams of corn oil is administered daily as placebo for 1 week with the same appearance and organoleptic condition. Yes - There is a plan to make this available What will be shared: Potentially the whole data will be published after participants become unidentified. When: The data will be available 6 months after data publication. To whom: Researchers working in academic and industrial institutions. Conditions: It can be used to carry out research work. Where to obtain: Dr. Hadi Esmaeili, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences. How to obtain: It will be available with sending a request by email to corresponding author (Esmaily_hadi@sbmu.ac.ir). Comments:
public Hadi Esmaily
Shahid Beheshti Pharmaceutical Faculty, Vali Asr Ave.
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0118 Esmaily_hadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Hadi Esmaily
Shahid Beheshti Pharmaceutical Faculty, Vali Asr Ave.
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0118 Esmaily_hadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Mild to moderate acute respiratory distress syndrome (ARDS) with PaO2/FiO2 between 100 and 300 mmHg Adult Patients (older than 18 years) Receiving mechanical ventilation Bilateral pulmonary infiltration 18 years no limit Both Hypersensitivity to any component of the product Pregnancy Platelet count below 50,000/µl Patients with increased risk of bleeding Hepatic insufficiency J80 Acute respiratory distress syndrome Treatment - Other Placebo Intervention group: The intervention group will receive 6 grams of eicosapentaenoic acid daily for 1 week as an add-on treatment. Control group: In this group, 6 grams of corn oil is administered daily as placebo for 1 week with the same appearance and organoleptic condition. Ratio of arterial partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (FiO2). Timepoint: Before intervention and 4 and 7 days after intervention. Method of measurement: Arterial Blood Gas (ABG) test. Duration of mechanical ventilation (days). Timepoint: Before intervention and at the time of extubation. Method of measurement: Observation. ICU length of stay (days). Timepoint: Before intervention and at the end of an ICU admission. Method of measurement: Observation. Organ Failure Assessment. Timepoint: Before intervention and 4 and 7 days after intervention. Method of measurement: Evaluation of various parameters such as clinical and blood serum factors. Changes in oxygenation and breathing pattern. Timepoint: Before intervention and 4 and 7 days after intervention. Method of measurement: Ventilator-derived parameters. Shahid Beheshti University of Medical Sciences Approved 2024-10-28 Ethics committee of Pharmacy Faculty, Shahid Beheshti University of Medical Sciences No.2660, Pharmacy Faculty, Shahid Beheshti University of Medical Sciences, Valiasr street Tehran Tehran Iran (Islamic Republic of)