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IRCT20221011056144N1 IRCT 2022-12-14 Karaj University of Medical Sciences The effect of albumin administration on mortality rate, lung involvement rate and blood oxygen in patients with covid-19 hospitalized in the intensive care unit Comparison of the effect of albumin administration on attenuation, lung involvement and blood oxygenation of patients with Covid-19 admitted to intensive care unit with albumin level less than 3 and 2 g dl ( Clinical Trial ) 2022-12-10 anticipated 52 Complete https://irct.ir/trial/67196 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: For the study subjects, before the random assignment, it is explained how the work process is and they may receive one of the two treatments randomly, and the drug used for the subjects is not known in advance, the form of the intervention drug and placebo and also, the frequency and times of administration of these two will be similar so that it is not possible for the patient and Outcome assessor to distinguish them from each other, so the patient and Outcome assessor will not know which group she is in. 2-3 Patients with covid-19. Intervention 1: Intervention group: After albumin reaches a level of less than 3 grams per deciliter, 20% albumin in 50 ml vials (company: CSL BEHRING, country of manufacture: Germany) will be administered, three vials daily, every eight hours for seven days. Intervention 2: Control group: If the albumin drops to less than 2 grams per deciliter, the same treatment as the intervention group will be performed. Yes - There is a plan to make this available What will be shared: The whole data can be shared after unidentifiable people. When: Start the access period 6 months after printing the results To whom: Only available to scholars working in academic and academic institutions. Conditions: Employed in research centers Where to obtain: Person responsible for scientific inquiries How to obtain: Send email to person responsible for scientific inquiries (afsanehzandi24@gmail.com). Comments:
public Afsaneh Zandi MD
Jahanshahr Street
Karaj Iran (Islamic Republic of) 3143744693 0098 26 344420 afsanehzandi24@gmail.com Karaj University of Medical Sciences scientific Afsaneh Zandi MD
Jahanshahr Street
Karaj Iran (Islamic Republic of) 3143744693 0098 26 344420 afsanehzandi24@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Age 18 years and above PCR test positive Observation of lung involvement in CT scan Hypoxia (arterial oxygen saturation less than 90%) Patients with consent to participate in the study 18 years no limit Both Hypoxia (arterial oxygen saturation more than 90%) U07.1 Covid-19, Virus identified Treatment - Drugs Treatment - Drugs Intervention group: After albumin reaches a level of less than 3 grams per deciliter, 20% albumin in 50 ml vials (company: CSL BEHRING, country of manufacture: Germany) will be administered, three vials daily, every eight hours for seven days. Control group: If the albumin drops to less than 2 grams per deciliter, the same treatment as the intervention group will be performed. Mortality rate. Timepoint: Seven days after treatment. Method of measurement: Based on the patient's file. Lung involvement rate. Timepoint: Seven days after treatment. Method of measurement: CT scan findings. Blood oxygen saturation percentage. Timepoint: Seven days after treatment. Method of measurement: Non-invasive monitoring device. Karaj University of Medical Sciences Approved 2022-11-11 Ethics Committee of Alborz University of Medical Sciences Second floor, Deputy of Research and Technology, Saffarian Alley, 45 meters from Golshahr, Karaj. Karaj Alborz Iran (Islamic Republic of)