]>
IRCT20120216009045N4 IRCT 2021-12-01 Tehran University of Medical Sciences Evaluation of the effect of 5% hypertonic saline nebulization on inflammatory factors and recovery in patients with severe pneumonia caused by covid 19 نبولایز سالین هیپرتونیک 5%در بیماران پنومونی شدید COVID-19 Evaluation of the Efficacy of nebulized 5% hypertonic saline on inflammatory factors and recovery of severe pneumonia in patients with Covid-19 hospitalized in intensive care units 2021-12-11 anticipated 40 Complete https://irct.ir/trial/55980 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with inclusion criteria were randomly divided into two groupsو A and B, using a random number table. Even numbers for groups A and odd numbers will be for group B. The researcher randomly touches the table and moves the numbers from top to bottom into two groups A or B based on being even and odd. Each number will belong to a patient. Of the 40 randomly selected patients, 20 patients in group A in the intervention group will be nebulized with 10 ml of 5% hypertonic saline every 6 hours. 20 patients in group B are nebulized with 10 ml of distilled water and the two groups will be compared in terms of inflammatory factors, Blinding description: The solutions are pre-prepared and coded in sterile, identical syringes. In order to double-blind the study, the syringe of each patient is delivered to the nurse based on the grouping. The person who nebulizes the solutions is not aware of the type of solution. The patient's blood sample is prepared and sent to the laboratory without knowing the type of nebulized solution. The experimenter was not aware of the grouping of patients and did not know which patient the blood sample belonged to. The researcher examines the laboratory results of each patient based on the set codes. 1 The effect of 5% hypertonic saline on blood levels of inflammatory factors in patients with severe pneumonia caused by covid 19. Intervention 1: Intervention group: Patients receiving 10 ml, 5% hypertonic saline nebulization during ICU admission. Intervention 2: Control group: Patients who receive 10 ml of distilled water through nebulization during hospitalization in the ICU. 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 There is no more information
public Mohammad Taghi Beigmohammadi
ICU group office, Imam Khomeini Hospital Complex, end of Keshavarz blv.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2511 mbage46@gmail.com Tehran University of Medical Sciences scientific Mohammad Taghi Beigmohammadi
ICU group office, Imam Khomeini Hospital Complex, end of Keshavarz blv.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2511 mbage46@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patient with Covid-19 coronavirus (confirmation of diagnosis by positive PCR test) Severe pneumonia due to COVID-19 Age 70 - 18 years Conscious consent of the patient or her guardian in cases that the patient is not conscious. 18 years 70 years Both Receiving interleukin production inhibitors such as Octemra Patients with a history of HIV + or any history of immunodeficiency Patient with active bacterial pneumonia Primary or metastatic lung cancer History of any cancer or malignancy Chronic lung diseases include: pulmonary fibrosis, bronchiectasis, asthma smoking Previous thoracic and lung surgery Patients with hypernatremia Intubated patients J12.8 Other viral pneumonia Treatment - Drugs Placebo Intervention group: Patients receiving 10 ml, 5% hypertonic saline nebulization during ICU admission Control group: Patients who receive 10 ml of distilled water through nebulization during hospitalization in the ICU. Interleukin 6. Timepoint: While hospitalized in the ICU for 5 days, before and after of intervention. Method of measurement: Samples containing the biomarkers are transferred to a reference laboratory in an EDTA-containing test tube, and centrifuged at 3,000 rpm for 15 minutes. The resulting plasma for measuring IL-6, TNF-α markers is stored by the researcher at minus 80 ° C. Quantitative determination is done by the quantitative sandwich enzyme immunoassay method by Bendermed commercial kits. Measurement of serum TNF_α before and after the intervention. Timepoint: During 5 days of admission in the ICU. Method of measurement: Samples containing the biomarkers are transferred to a reference laboratory in an EDTA-containing test tube, and centrifuged at 3,000 rpm for 15 minutes. The resulting plasma for measuring IL-6, TNF-α markers is stored by the researcher at minus 80 ° C. Quantitative determination is done by the quantitative sandwich enzyme immunoassay method by Bendermed commercial kits. Mortality rate in two groups. Timepoint: During admission in the ICU. Method of measurement: Status of patient leaving ICU: alive or dead. Tehran University of Medical Sciences Approved 2020-05-24 Ethics Committee of Tehran University of Medical Sciences Headquarters of Tehran University of Medical Sciences, Ghods st, keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)