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IRCT20110425006280N12 IRCT 2021-08-14 Vice President of Research Guilan university of medical sciences Hemoperfusion effect in treatment of patients with COVID-19 Evaluation of Hemoperfusion effect in treatment of patients with COVID-19 hospitalized in intensive care unit, Randomized clinical trial 2021-08-23 anticipated 20 Complete https://irct.ir/trial/57738 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients will enter each of the two treatment groups randomly using a 1: 1 block randomization method. Twenty patients with a diagnosis of Covid 19 will be divided into 2 groups of 10 intervention and control. The hemoperfusion group is called A and the control group is called B.Random blocking will be done in such a way that the research units are assigned numbers 1-20, respectively. Then a table with 6 rows called blocks and each block will have 4 parts and each part will be named with A and B, will be considered. In the next step, the numbers will be placed in each house in order. After all the numbers are placed in the blocks, the people who had the number in house A will receive the hemoperfusion method and the people who had the number in house B will be considered the control group. The website https://www.sealedenvelope.com is used for randomization. For hiding, the Allocation concealment method will be used. So that before the individual is assigned, the assigned group is not specified. In this method, using the same sealed envelopes, with a random sequence in which each of the random sequences created on this card is recorded and the cards inside the envelopes will be placed in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. At the beginning of the registration of eligible patients, one of the envelopes will be opened and the patient will be a candidate for hemoperfusion or control group, Blinding description: Participants and health care providers responsible for patients' health will not go blind and are informed about the therapy groups . Radiologists, researchers evaluating the research and statistical expertise will be blind. Sequentially numbered opaque, sealed envelopes: Envelopes method is used to hide random allocation. N/A The effect of Hemoperfusion in the treatment of covid-19 disease. Intervention 1: Intervention group includes 10 patients who enter the study after obtaining the informed consent of the patient or her companion and receive the standard COVID-19 treatment regimen along with 3 sessions of hemoperfusion according to the protocol provided by the Ministry of Health.The standard treatment includes the antiviral drug remedicivier and interferon ReciGen and the use of corticosteroids and dexamethasone and other complementary measures such as anticoagulants and antacids and sedatives.The use of a homeperfusion device can be alone or in combination. In the combined use of hemoperfusion, the cartridge is placed before the hemodialysis filter or hemofilter.Cartridge used: Jafron HA 330 - Number of sessions: 3 - Device: Hemoperfusion - Pump speed of the device: 250 to 300 - Duration of each session: 4 hours - Interval between sessions: 8 to 12 hours - Low-dose of heparin will be infused. It is prescribed at a dose of 10 to 15 units per kilogram per hour to avoid cartridge damage.If CVVH mode is established and added from CRRT, the dose of heparin will increase to 15-20 units per kilogram per hour.For hemoperfusion, you can use a special device for hemoperfusion or if you do not have access to a hemoperfusion device, you can use a hemodialysis machine, because to perform hemoperfusion, you need vascular access (shaldon) and a pump that removes blood from the body and returns it to the body And a hemodialysis machine makes this possible.Patients are monitored daily for vital signs, electrolytes, blood sugar, liver tests, kidney tests, blood cells, coagulation factors, LDH, inflammatory factors, and chest radiographs.To compare the effectiveness and speed of recovery between the two intervention and control groups, changes in clinical symptoms (fever, oxygen saturation, alertness, blood pressure, heart rate, respiratory distress, etc.) and paraclinical changes (changes in chest imaging, changes in lymphocyte count). LDH, changes in CRP, ESR, D.DIMER, serum creatinine, ALT, AST, bilirubin and alkaline phosphatase, interleukin 6 and ferritin) are checked twice a week. Intervention 2: Control group includes 10 patients who enter the study after obtaining the informed consent of the patient or her companion and receive the standard COVID-19 treatment regimen.The standard treatment includes the antiviral drug remedicivier and interferon ReciGen and the use of corticosteroids and dexamethasone and other complementary measures such as anticoagulants and antacids and sedatives.Patients are monitored daily for vital signs, electrolytes, blood sugar, liver tests, kidney tests, blood cells, coagulation factors, LDH, inflammatory factors, and chest radiographs.To compare the effectiveness and speed of recovery between the two intervention and control groups, changes in clinical symptoms (fever, oxygen saturation, alertness, blood pressure, heart rate, respiratory distress, etc.) and paraclinical changes (changes in chest imaging, changes in lymphocyte count). LDH, changes in CRP, ESR, D.DIMER, serum creatinine, ALT, AST, bilirubin and alkaline phosphatase, interleukin 6 and ferritin) are checked twice a week. 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 Not yet decided
public Mohammad Haghighi
Razi Hospital, Sardar Jangal Street, Rasht
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3211 1319 mohaghighi@gums.ac.ir Guilan University of Medical Sciences scientific Mohamad Haghighi
Razi Hospital, Sardar Jangal Street, Rasht
Rasht Iran (Islamic Republic of) 4193713194 +98 13 1322 3970 manesthesist@gmail.com Guilan University of Medical Sciences Iran (Islamic Republic of) Patients with a clinical diagnosis of Covid-19 including respiratory distress with a rate of more than 30 per minute and heart rate more than 125 beats per minute and shortness of breath and oxygen saturation less than 90%, despite receiving oxygen with a positive PCR test and Radiographs in CT SCANING or Chest X Ray, admitted to the intensive care unit. Uncontrollable fevers like T> 39 C. An laboratory evidence of increased inflammatory factors Patients 12 years and older Evidence of severe hemodynamic disturbance using moderate doses of norepinephrine or using a second dose of vasopressor Involvement of more than two vital organs (lungs, kidneys, liver, and heart) 12 years no limit Both Thrombocytopenia (Plt ≤20,000) Pregnancy Acute crisis due to sickle cell anemia Evidence of resin sensitivity U07.1 COVID-19, virus identified Treatment - Devices N/A Intervention group includes 10 patients who enter the study after obtaining the informed consent of the patient or her companion and receive the standard COVID-19 treatment regimen along with 3 sessions of hemoperfusion according to the protocol provided by the Ministry of Health.The standard treatment includes the antiviral drug remedicivier and interferon ReciGen and the use of corticosteroids and dexamethasone and other complementary measures such as anticoagulants and antacids and sedatives.The use of a homeperfusion device can be alone or in combination. In the combined use of hemoperfusion, the cartridge is placed before the hemodialysis filter or hemofilter.Cartridge used: Jafron HA 330 - Number of sessions: 3 - Device: Hemoperfusion - Pump speed of the device: 250 to 300 - Duration of each session: 4 hours - Interval between sessions: 8 to 12 hours - Low-dose of heparin will be infused. It is prescribed at a dose of 10 to 15 units per kilogram per hour to avoid cartridge damage.If CVVH mode is established and added from CRRT, the dose of heparin will increase to 15-20 units per kilogram per hour.For hemoperfusion, you can use a special device for hemoperfusion or if you do not have access to a hemoperfusion device, you can use a hemodialysis machine, because to perform hemoperfusion, you need vascular access (shaldon) and a pump that removes blood from the body and returns it to the body And a hemodialysis machine makes this possible.Patients are monitored daily for vital signs, electrolytes, blood sugar, liver tests, kidney tests, blood cells, coagulation factors, LDH, inflammatory factors, and chest radiographs.To compare the effectiveness and speed of recovery between the two intervention and control groups, changes in clinical symptoms (fever, oxygen saturation, alertness, blood pressure, heart rate, respiratory distress, etc.) and paraclinical changes (changes in chest imaging, changes in lymphocyte count). LDH, changes in CRP, ESR, D.DIMER, serum creatinine, ALT, AST, bilirubin and alkaline phosphatase, interleukin 6 and ferritin) are checked twice a week. Control group includes 10 patients who enter the study after obtaining the informed consent of the patient or her companion and receive the standard COVID-19 treatment regimen.The standard treatment includes the antiviral drug remedicivier and interferon ReciGen and the use of corticosteroids and dexamethasone and other complementary measures such as anticoagulants and antacids and sedatives.Patients are monitored daily for vital signs, electrolytes, blood sugar, liver tests, kidney tests, blood cells, coagulation factors, LDH, inflammatory factors, and chest radiographs.To compare the effectiveness and speed of recovery between the two intervention and control groups, changes in clinical symptoms (fever, oxygen saturation, alertness, blood pressure, heart rate, respiratory distress, etc.) and paraclinical changes (changes in chest imaging, changes in lymphocyte count). LDH, changes in CRP, ESR, D.DIMER, serum creatinine, ALT, AST, bilirubin and alkaline phosphatase, interleukin 6 and ferritin) are checked twice a week. Improving the patient's clinical condition. Timepoint: Daily. Method of measurement: Evaluation of the presence of Respiratory distress, marked improvement in patients respiration rate, improvement in arterial blood gas condition and self-expression, improvement in patient's heart rate and improvement in patient's inflammatory tests 2-3 days after home perfusion. Inflammatory tests include D.DIMER, IL-6 LDH, FERRITIN, FIBRINOGEN, CRP. Vice President of Research Guilan university of medical sciences Approved 2021-06-30 Ethical Comeetee of Guilan University of Medical Sciences Namjoo Avenue, Deputy department OF Guilan University of Medical Sciences Rasht Guilan Iran (Islamic Republic of)