Effect of Hemoperfusion on short term survival of critical ill COVID-19 patients admitted to ICU
Design
Randomized, superiority, parallel group, phase 3, single-center trial with blinded outcome assessment. Randomization will be performed using qua-ternary blocking randomization.
Settings and conduct
Patients with Covid 19 admitted to the ICU of Imam Reza Hospital will be randomly assigned to the intervention and control groups. In the intervention group, in addition to routine treatments based on the national protocol, they will undergo hemoperfusion for 14-16 hours, and in the control group, only routine treatments of the intensive care unit based on the national protocol. It will be used to compare the effects of the effect of hemoperfusion on the short-term prognosis of patients in the intensive care unit of Covid_19 patients.Patients and their next of kin as well as the researcher who will assess the outcomes will be blind to the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients 18 to 75 years of age with Covid 19
Absence of active bleeding
Absence of irreversible disease
Existence of pulmonary involvement more than 50%
Exclusion criteria:
Pregnancy
Dissatisfaction of the patient or the patient's companion
Intervention groups
Intervention group: This group will be performed under routine treatments in the intensive care unit according to the national protocol for Covid 19 patients plus 14-16 hours of hemoperfusion. Before and after each hemoperfusion session, disease severity factors will be checked and based on the symptoms and severity of the markers, if necessary, hemoperfusion will be repeated for up to 3 sessions. In the control group, only routine treatments of the intensive care unit will be provided according to the national protocol.
Main outcome variables
Duration of hospital stay in ICU, duration of mechanical ventilation, mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002582N22
Registration date:2020-08-08, 1399/05/18
Registration timing:prospective
Last update:2020-08-08, 1399/05/18
Update count:0
Registration date
2020-08-08, 1399/05/18
Registrant information
Name
Ata Mahmoodpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 0888
Email address
mahmoodpoora@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hemoperfusion on short-term outcome of critically ill COVID-19 patients admitted to ICU
Public title
Effect of hemoperfusion on short term outcome of critical ill COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18 to 75 years of age with Covid 19
Absence of active bleeding
Absence of irreversible disease
Existence of pulmonary involvement more than 50%
Exclusion criteria:
Pregnancy
Dissatisfaction of the patient or the patient's companion
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, the blocks (n=4) with different arrangements of A and B will be defined. Considering the different probable arrangement of A and B, blocks will be numbered from 1 to 6. To enroll initial 4 patients into the study, one of the arrangements will be selected using the random digit table and the patients will be assigned into the A and B groups accordingly. For the next 4 patients, the arrangement pattern will be selected again and the patients will be assigned to the groups and this cycle will be repeated to achieve our intended sample size. Unpredictability of assignment and balancing the number of patients across the two groups during or at the end of the study are main advantages of this method. Notably, the patients will be assigned into the study based on the ICU date of admission and no body will be able to assign the patients to the specific group of interest.
Blinding (investigator's opinion)
Double blinded
Blinding description
The aim of double blinding is the avoidance of patients and researchers from being informed about the study intervention, so enrollment of patients in intervention and placebo groups will not be recognized. The informed consent will be obtained from the patient's next of kin and they will thoroughly be informed about the study but they will be blind about the group in which their patient will be included. Also, the researcher who will assess the outcomes will not have any information about study enrollment and only primary investigator will know that. So, blinding will be performed for the researcher who will assess the study outcomes. As he/she will not be a member of treatment team and will be blinded to the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5183915881
Approval date
2020-08-02, 1399/05/12
Ethics committee reference number
IR.TBZMED.REC.1399.493
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Duration of mechanical ventilation.
Timepoint
From the time the patient enters the ICU until discharge from this ward.
Method of measurement
Number of days the patient is under mechanical ventilation based on patients recorded information
Secondary outcomes
1
Description
Mortality
Timepoint
From the beginning of the interventions to 28 days after the end of the interventions
Method of measurement
Mortality counting based on patients recorded information
2
Description
ICU length of stay
Timepoint
From the time of the patient's arrival until the discharge of ICU
Method of measurement
According to the number of days the patient was hospitalized in the ICU
Intervention groups
1
Description
Control group:In the control group, patients will receive all standard treatments as follows: In case of no mechanical ventilation, use of NIV or face mask in case of mechanical ventilation, Lung protective strategy / low tidal volume ventilation with a target volume of 6 ml / kg of ideal body weight with the aim of plateau pressure below 30 and Driving pressure below 50 and maintaining oxygenation and carbon dioxide pressure will be desirable. Patients will receive antiviral therapy and corticosteroids. Patients with a goal of 25 kcal per kg of body weight will be fed daily and laterally, and if this is not possible, this energy will be provided parenterally. Blood sugar control in the range 140-180 will be performed for all patients.PPI treatment to prevent ulcer stress and anticoagulant therapy with prophylactic dose will be performed for all patients. Complementary medications will be prescribed as needed. All patients will undergo the ABCDE protocol for monitoring delirium treatment.
Category
Treatment - Devices
2
Description
Intervention group:In the hemoperfusion group, in addition to the treatments in the control group, patients will be hemoperfused for 16-14 hours with a cytosorbe filter of 300 and BFR: 250-300 ml / min and heparin at a dose of 10-15 IV / Kg / h. PTT Patients will be performed every 4 hours to maintain PTT in the treatment area. Before and after each hemoperfusion session, the disease severity factors will be checked and based on the symptoms and severity of the markers, if necessary, hemoperfusion will be repeated for up to 3 sessions.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
General ICU, Imam Reza Hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
Imam Reza Hospital, Daneshkade street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2073
Fax
+98 41 3335 2073
Email
amahmoodpoor@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. khosro Adibkia
Street address
Vice Chancellor for Research, Daneshgah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Fax
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mojtaba Mohammadzadeh
Position
subspeciality resident
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Daneshkade Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2073
Fax
+98 41 3335 2073
Email
drmojtaba@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Daneshkade street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2073
Fax
+98 41 3335 2073
Email
amahmoodpoor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojtaba Mohammadzadeh
Position
Subspeciality Resident
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Daneshkade Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2073
Fax
+98 41 3335 2073
Email
drmojtaba@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All potential data can be shared after making peoples unrecognizable.
When the data will become available and for how long
Starting 6 months after publication .
To whom data/document is available
Documents will be available for people working in academic institutions and also people working in businesses.
Under which criteria data/document could be used
There will be no specific limitations to the utilization of the data
From where data/document is obtainable
Dr .Ata Mahmoodpoor, Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran ,Phone+98 413 3341994, Fax+98 41 33341994 , amahmoodpoor@yahoo.com
What processes are involved for a request to access data/document
Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week.