Using blood purification techniques for remove cytokines induced ARDS
Design
In this one-center study, we will perform 12 confirmed cases of 2019-nCoV at Masih Daneshvari Hospital in Tehran, Tehran, and cases where 2019-nCoV will be confirmed by RT-PCR using blood purification methods, patients in two groups CRRT / Hemoperfusion + CRRT(Continuous Renal Replacement Therapy) will be divided and their mortality rates will be compared
Settings and conduct
Patients hospitalized in the intensive care unit who did not respond to normal treatment and had high interleukin 6 will be treated with CRRT three times with CRRT in the intensive care unit, and the other group will be treated with hemodialysis and CRRT three times.
Participants/Inclusion and exclusion criteria
Patients in the intensive care unit
Patients with pao2.fio2 below 150
interleukin above 100 pg / ml
Age over 18 years
Intervention groups
The first intervention group used CRRT three times a week in patients admitted to the treatment plan after reviewing the study selection criteria, the duration of each CRRT session, twenty-four hours, and then the measurement of interleukin six on days one and six. And seven after CRRT
The second intervention group
Use of HP.CRRT three times a week in patients admitted to the treatment plan after reviewing the study selection criteria, the duration of each HP.CRRT session, twenty-four hours, and then measuring interleukin six on days one and Six and seven after performing HP.CRRT
Main outcome variables
mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150107020592N29
Registration date:2020-06-21, 1399/04/01
Registration timing:retrospective
Last update:2020-06-21, 1399/04/01
Update count:0
Registration date
2020-06-21, 1399/04/01
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9944
Email address
iran.criticalcare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
2020-03-20, 1399/01/01
Actual recruitment end date
2020-05-21, 1399/03/01
Trial completion date
2020-05-21, 1399/03/01
Scientific title
Efficacy of Blood Purification Techniques on Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Pneumonia
Public title
Efficacy of Blood Purification Techniques on COVID-19 Pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
covid-19 patients
PaO2/FiO2 ratio (partial pressure of arterial oxygen/fraction of inspired oxygen) under 150
Interloquin 6 above 100 pg/ml
Exclusion criteria:
Patients under 18 years of age
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
12
Actual sample size reached:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Masih Daneshvari Hospital the Edjucational , Research and Treatment center
Street address
End of Niavaran, Darabadational , Research and Treatment center.
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.011
Health conditions studied
1
Description of health condition studied
covid-19 patients
ICD-10 code
U07.1
ICD-10 code description
COVID-19 Disease
Primary outcomes
1
Description
oxygenation
Timepoint
Daily after the procedure until discharge or death
Method of measurement
pulse Oximetry
2
Description
Mortality
Timepoint
discharge time
Method of measurement
Death
3
Description
Interleukin 6
Timepoint
Measurement of interleukin at intervals of one, six and seven days
Method of measurement
laboratory kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: : Use of Continuous Renal Replacement Theraphy with anti-complement filter with crrt system, three times a week in patients admitted to the treatment plan after reviewing the study selection criteria, the duration of each CRRT session, twenty-four hours, and then measuring interleukin six on days one, six, and seven. From CRRT
Category
Treatment - Devices
2
Description
Intervention group: Use of Hemoperfusion three times a week in patients admitted to the treatment plan after reviewing the study selection criteria, the duration of each Hemoperfusion session, twenty-four hours, and then measuring interleukin six on days one, six, and seven. From Hemoperfusion
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Seyyed Mohammadreza Hashemian
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2265
Email
iran.criticalcare@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Seyyad Mohammadreza Hashemian
Street address
End of Niavaran Darabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 9512
Email
iran.criticalcare@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mohammad reza Hashemian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Phone
+98 21 2610 9512
Fax
Email
smrhashemian@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mohammad reza Hashemian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Phone
+98 21 2610 9512
Fax
Email
smrhashemian@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mohammad Reza Hashemian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Phone
+98 912 111 9279
Fax
Email
iran.criticalcare@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All patient information can be published after deleting the name
When the data will become available and for how long
It will take a month from the time of application
To whom data/document is available
All professors of medical universities in the country
Under which criteria data/document could be used
If the professors present their proposal and letter from their university by sending a message to Dr. Hashemian's e-mail, they will send their e-mail request and the names and numbers of the patients will be deleted and their questionnaires, data and analysis will be sent to their e-mails.
From where data/document is obtainable
professor hashemian in masih daneshvari hospital
What processes are involved for a request to access data/document