Determination of plasmapheresis effect and plasma replacement in patients with covid 19
Design
Use of plasmapheresis three times with 60% replacement of albumin 5% for one week in patients admitted to the treatment plan after reviewing the study selection criteria, and if the patient's blood pressure is allowed, plasma exchange with 100% replacement albumin 5%
The duration of each plasmapheresis session is a maximum of 4 hours
Settings and conduct
Patients hospitalized in the intensive care unit who have not responded to normal treatment and have high interleukin 6 will be placed in the intensive care unit three times by plasmapheresis with a dialysis machine and will undergo plasma excision in case of normal vital signs.
Participants/Inclusion and exclusion criteria
1.age of patients ranged between 8 to 16 years
2.COVID-19 positive
3. interleukin above 6
4.Patients hospitalized in the intensive care unit
5.Increased respiration rate (be30 beats / min), difficulty breathing, cyanosis of the lips
6.Oxygen saturation percentage ≤93%
7-Patients with covid-19 disease receiving antiretroviral therapy such as Favipiravir remdesivir, and kaletra have experienced an increase in interleukin and a cytokine storm during treatment.
Intervention groups
Our patients will undergo plasmapheresis three times to reduce interleukin and inflammatory factors and, if their hemodynamics allowed, plasma ٍexchange will be done for them.
Main outcome variables
interleukin 6
oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150107020592N23
Registration date:2020-05-31, 1399/03/11
Registration timing:registered_while_recruiting
Last update:2020-05-31, 1399/03/11
Update count:0
Registration date
2020-05-31, 1399/03/11
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
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Plasmapheresis and plasma exchanges;usefulness in covid-19 critically ill patients
Public title
Plasmapheresis and plasma exchanges;usefulness in covid-19 critically ill patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age of patients ranged between 8 to 16 years2.COVID-19 POSITIVE3. interleukin above 6 4.Patients hospitalized in the intensive care unit5.Increased respiration rate (be30 beats / min), difficulty breathing, cyanosis of the lips6.Oxygen saturation percentage ≤93%
.COVID-19 positive
interleukin above 6
Patients hospitalized in the intensive care unit
Increased respiration rate (be30 beats / min), difficulty breathing, cyanosis of the lips
Oxygen saturation percentage ≤93%,PaO2 / FiO2 ≤300 mmHg
Patients with covid-19 disease receiving antiretroviral therapy such as Favipiravir ,remdesivir, and kaletra have experienced an increase in interleukin and a cytokine storm during treatment.
Exclusion criteria:
Patients treated with other interleukin-lowering methods, such as Actemra
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
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 Shahid Beheshti University of Medical Sciences
Street address
Yemen Street, Shahid Chamran Highway, Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.016
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19 Disease
Primary outcomes
1
Description
oxygen percentage
Timepoint
One day before the procedure and one day and four days and seven days after the procedure
Method of measurement
Pulse Oximeter device
2
Description
interleukin 6 level
Timepoint
Before the procedure and one day and six days and seven days after the three-phase plasmapheresis
Method of measurement
Lab kit
Secondary outcomes
empty
Intervention groups
1
Description
Use plasmapheresis three times with 60% replacement of albumin 5% for one week in patients admitted to the treatment plan after reviewing the study selection criteria, and if the patient's blood pressure is allowed, plasma exchange with replacement with 100% albumin 5% duration of each session. Plasmapheresis maximum 4 hours and then measure interleukin-6 on days one, six and seven after plasmapheresis or plasma exchange
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital the Edjucational , Research and Treatment center
Full name of responsible person
Dr Seyyed Mohamadreza Hashemian
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2912 3100
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, Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1957544413
Phone
+98 21 2610 9944
Fax
+98 21 2610 9944
Email
iran.criticalcare@yahoo.com
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, Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1957544413
Phone
+98 21 2610 9944
Fax
+98 21 2610 9944
Email
iran.criticalcare@yahoo.com
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, Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1957544413
Phone
+98 21 2610 9944
Fax
+98 21 2610 9944
Email
iran.criticalcare@yahoo.com
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 of data after delete names are available
When the data will become available and for how long
one year after research
To whom data/document is available
all medical personnel
Under which criteria data/document could be used
Help for education
From where data/document is obtainable
Dr Smr hashemian
What processes are involved for a request to access data/document