Investigating the effects of modified ultrafiltration on rotational thromboelastometry (ROTEM) and inflammatory cytokine response in patients under cardiopulmonary bypass surgery
Patients undergoing elective coronary artery bypass using cardiopulmonary bypass complying with the inclusion criteria will be randomly assigned into two different groups: conventional filtration plus modified ultrafiltration and conventional filtration. Blood samples will be drawn from patients in three time points: after cross-clamp opening, after separation from pump and 24 hours after operation. Then cytokine levels will be measured using ELISA method.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017042127617N3
Registration date:2017-06-02, 1396/03/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-02, 1396/03/12
Registrant information
Name
Hamidreza Pazoki-Toroudi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 2708
Email address
pazoki49@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-05-08, 1396/02/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of modified ultrafiltration on rotational thromboelastometry (ROTEM) and inflammatory cytokine response in patients under cardiopulmonary bypass surgery
Public title
Investigating the effects of modified ultrafiltration on rotational thromboelastometry (ROTEM) and inflammatory cytokine response in patients under cardiopulmonary bypass surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients candidated for cardiopulmonary bypass surgery; cardiopulmonary bypass time from 50 to 120 minutes; number of grafts 3 or 4,/
Exclusion criteria: patient denying to participate in the study; cardiac conditions/comorbidities affecting the
recovery after sternotomy; previous history of cardiac arrest; use of defibrilator during operation
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
We will use simple randomization using random digits table to assign subjects to two parallel groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Hemmat expway, Next to Milad Tower
City
Tehran
Postal code
Approval date
2017-01-29, 1395/11/10
Ethics committee reference number
IR.IUMS.REC 1395.9311248001
Health conditions studied
1
Description of health condition studied
coronary artery disease
ICD-10 code
125.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
ROTEM parameters
Timepoint
After declamp, after separation from pump, 24 hours after operation
Method of measurement
Plasma analysis using ROTEM machine
2
Description
Hemoglobin and hematocrit
Timepoint
Before and after operation
Method of measurement
Biochemical analysis
3
Description
Inflammatory cytokine response (IL-6, -8, -10 and TNF-alpha)
Timepoint
After declamp, after separation from pump, 24 hours after operation
Method of measurement
Plasma analysis using ELISA technique
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention model, conventional ultrafiltration will be performed during operation and modified ultrafiltration will be applied after cardiopulmonary bypass.
Category
Treatment - Other
2
Description
In the control group, only conventional ultrafiltration will be applied during operation.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Farhad Gorjipour
Street address
Niyayesh Crossroad, Valiasr Avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Ali Javad Mousavi
Street address
Next to Milad Tower, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Farhad Gorjipour
Position
Perfusionist practitioner
Other areas of specialty/work
Street address
Niyayesh crossroad, Valiasr Avenue
City
Tehran
Postal code
Phone
+98 21 2392 2472
Fax
Email
gorjipoorf@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Meysam Mortazian
Position
Cardiovascular surgery fellowship
Other areas of specialty/work
Street address
Niyayesh Crossroad, Valiasr Avenue
City
Tehran
Postal code
Phone
+98 21 2392 2424
Fax
Email
M_MOTZIAN@YAHOO.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Farhad Gorjipour
Position
Perfusionist
Other areas of specialty/work
Street address
Niyayesh Crossroad, Valiasr Avenue
City
Tehran
Postal code
Phone
+98 21 2392 2424
Fax
Email
gorjipoorf@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)