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IRCT20091012002582N22 IRCT 2020-08-08 Tabriz University of Medical Sciences Effect of hemoperfusion on short term outcome of critical ill COVID-19 Effect of hemoperfusion on short-term outcome of critically ill COVID-19 patients admitted to ICU 2020-08-22 anticipated 160 Complete https://irct.ir/trial/50079 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Initially, the blocks (n=4) with different arrangements of A and B will be defined. Considering the different probable arrangement of A and B, blocks will be numbered from 1 to 6. To enroll initial 4 patients into the study, one of the arrangements will be selected using the random digit table and the patients will be assigned into the A and B groups accordingly. For the next 4 patients, the arrangement pattern will be selected again and the patients will be assigned to the groups and this cycle will be repeated to achieve our intended sample size. Unpredictability of assignment and balancing the number of patients across the two groups during or at the end of the study are main advantages of this method. Notably, the patients will be assigned into the study based on the ICU date of admission and no body will be able to assign the patients to the specific group of interest, Blinding description: The aim of double blinding is the avoidance of patients and researchers from being informed about the study intervention, so enrollment of patients in intervention and placebo groups will not be recognized. The informed consent will be obtained from the patient's next of kin and they will thoroughly be informed about the study but they will be blind about the group in which their patient will be included. Also, the researcher who will assess the outcomes will not have any information about study enrollment and only primary investigator will know that. So, blinding will be performed for the researcher who will assess the study outcomes. As he/she will not be a member of treatment team and will be blinded to the study groups. 3 COVID-19. Intervention 1: Control group:In the control group, patients will receive all standard treatments as follows: In case of no mechanical ventilation, use of NIV or face mask in case of mechanical ventilation, Lung protective strategy / low tidal volume ventilation with a target volume of 6 ml / kg of ideal body weight with the aim of plateau pressure below 30 and Driving pressure below 50 and maintaining oxygenation and carbon dioxide pressure will be desirable. Patients will receive antiviral therapy and corticosteroids. Patients with a goal of 25 kcal per kg of body weight will be fed daily and laterally, and if this is not possible, this energy will be provided parenterally. Blood sugar control in the range 140-180 will be performed for all patients.PPI treatment to prevent ulcer stress and anticoagulant therapy with prophylactic dose will be performed for all patients. Complementary medications will be prescribed as needed. All patients will undergo the ABCDE protocol for monitoring delirium treatment. Intervention 2: Intervention group:In the hemoperfusion group, in addition to the treatments in the control group, patients will be hemoperfused for 16-14 hours with a cytosorbe filter of 300 and BFR: 250-300 ml / min and heparin at a dose of 10-15 IV / Kg / h. PTT Patients will be performed every 4 hours to maintain PTT in the treatment area. Before and after each hemoperfusion session, the disease severity factors will be checked and based on the symptoms and severity of the markers, if necessary, hemoperfusion will be repeated for up to 3 sessions. Yes - There is a plan to make this available What will be shared: All potential data can be shared after making peoples unrecognizable. When: Starting 6 months after publication . To whom: Documents will be available for people working in academic institutions and also people working in businesses. Conditions: There will be no specific limitations to the utilization of the data Where to obtain: Dr .Ata Mahmoodpoor, Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran ,Phone+98 413 3341994, Fax+98 41 33341994 , amahmoodpoor@yahoo.com How to obtain: Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week. Comments:
public Mojtaba Mohammadzadeh
Imam Reza Hospital, Daneshkade Street
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3335 2073 drmojtaba@yahoo.com Tabriz University of Medical Sciences scientific Ata Mahmoodpoor
Imam Reza Hospital, Daneshkade street
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3335 2073 amahmoodpoor@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients 18 to 75 years of age with Covid 19 Absence of active bleeding Absence of irreversible disease Existence of pulmonary involvement more than 50% 18 years 75 years Both Pregnancy Dissatisfaction of the patient or the patient's companion U07.1 COVID-19 Treatment - Devices Treatment - Devices Control group:In the control group, patients will receive all standard treatments as follows: In case of no mechanical ventilation, use of NIV or face mask in case of mechanical ventilation, Lung protective strategy / low tidal volume ventilation with a target volume of 6 ml / kg of ideal body weight with the aim of plateau pressure below 30 and Driving pressure below 50 and maintaining oxygenation and carbon dioxide pressure will be desirable. Patients will receive antiviral therapy and corticosteroids. Patients with a goal of 25 kcal per kg of body weight will be fed daily and laterally, and if this is not possible, this energy will be provided parenterally. Blood sugar control in the range 140-180 will be performed for all patients.PPI treatment to prevent ulcer stress and anticoagulant therapy with prophylactic dose will be performed for all patients. Complementary medications will be prescribed as needed. All patients will undergo the ABCDE protocol for monitoring delirium treatment. Intervention group:In the hemoperfusion group, in addition to the treatments in the control group, patients will be hemoperfused for 16-14 hours with a cytosorbe filter of 300 and BFR: 250-300 ml / min and heparin at a dose of 10-15 IV / Kg / h. PTT Patients will be performed every 4 hours to maintain PTT in the treatment area. Before and after each hemoperfusion session, the disease severity factors will be checked and based on the symptoms and severity of the markers, if necessary, hemoperfusion will be repeated for up to 3 sessions. Duration of mechanical ventilation. Timepoint: From the time the patient enters the ICU until discharge from this ward. Method of measurement: Number of days the patient is under mechanical ventilation based on patients recorded information. Mortality. Timepoint: From the beginning of the interventions to 28 days after the end of the interventions. Method of measurement: Mortality counting based on patients recorded information. ICU length of stay. Timepoint: From the time of the patient's arrival until the discharge of ICU. Method of measurement: According to the number of days the patient was hospitalized in the ICU. Tabriz University of Medical Sciences Approved 2020-08-02 Ethic Committee of Tabriz University of Medical Sciences Vice chancellor for research, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)