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
Determination of the effect of 5% hypertonic saline on inflammatory mediators in patients with severe pneumonia caused by Covid-19 admitted to ICU
Design
This study is a randomized controlled double-blind clinical trial.
Settings and conduct
The study will be performed in the special wards of Imam Khomeini Hospital in Tehran. The study population will be 40 male and female patients between the ages of 18 and 70 in the ICU. Patients with inclusion criteria will be randomly divided into two groups of 20 people A and B. In group A, 10 ml of 5% hypertonic saline and in group B, 10 ml of distilled water for 6 hours will be nebulized for 5 days. The person preparing the samples and performing the tests, as well as recording and following up the consequences, are separate and are not aware of the type of intervention in the patient. The patient's nurse performs nebulizes of the solution based on the codes provided to her.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with severe pneumonia caused by Covid-19 admitted to the ICU, age between 18-70 years old, Conscious consent of the patient or his/her family .
Non-entry conditions: use of interleukin production inhibitors, history of immunodeficiency, active bacterial pneumonia, hypernatremia, previous thoracic and lung surgery, intubation patients
Intervention groups
Intervention group A: Nebulization of 10 ml of 5% NaCl every 6 hours.
Intervention group B: Nebulization of 10 ml of distilled water every 6 hours.
Main outcome variables
Blood levels of interleukin 6; Blood levels of TNFα; Duration of hospitalization in the ICU; death; Pao2 / fio2 ratio
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
Public title
Evaluation of the effect of 5% hypertonic saline nebulization on inflammatory factors and recovery in patients with severe pneumonia caused by covid 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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
Age
From 18 years old to 70 years old
Gender
Both
Phase
1
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Headquarters of Tehran University of Medical Sciences, Ghods st, keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Approval date
2020-05-24, 1399/03/04
Ethics committee reference number
TR.TUMS.IKHC.REC.1400.016
Health conditions studied
1
Description of health condition studied
The effect of 5% hypertonic saline on blood levels of inflammatory factors in patients with severe pneumonia caused by covid 19
ICD-10 code
J12.8
ICD-10 code description
Other viral pneumonia
Primary outcomes
1
Description
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.
2
Description
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.