The aim of study is to evaluate the effect of hemofilter during cardiac surgery(with normal kidney function) on postoperative kidney, heart and lung finction. with consideration of inclusion and exclusion criteria 200 patients will be recruited for the study. They will be randomly assigned to either an ultrafiltration group (n=100) or to a control group (n=100). Ultrafiltration (Minntech hemoconcentrator, Hemocor HPH 1400) will be done during cardiopulmonary bypass (40cc/kg). Urinary NGAL were measured after urinary caheterizaion, and 2 hours after arrival at the intensive care unit, using ELISA test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103053438N3
Registration date:2011-06-03, 1390/03/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-03, 1390/03/13
Registrant information
Name
Mahnoosh Foroughi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2236 0635
Email address
m_foroughi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urology and Nephrology Research Center
Shaheed Beheshti Medical Sience
Expected recruitment start date
2010-10-07, 1389/07/15
Expected recruitment end date
2011-10-07, 1390/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ultrafiltration during cardiac surgery on Urinary neutrophil-associated lipocalin (NGAL)
Public title
Effect of ultrafiltration on kidney function
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Patients with coronary artery disease or vavular disease that come for elective first time on-pump operation will be recruited for the study.
Exclusion criteria:cre>1.5mg/dl, less than 3 days interval between angiography( dye contrast) till operation, urinary infection( presence of bacteria on urinary exam),Chronic lung disease(history of bronchodilator use or FEV1 less than 60%on spirometry), combine operation(coronary and valve) and urgent/emergency cases
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urology and Nephrology Research Center
Street address
Urology and Nephrology Research Center-aside Labbafi Hospital
City
Tehran
Postal code
Approval date
2010-09-30, 1389/07/08
Ethics committee reference number
27-3-89
Health conditions studied
1
Description of health condition studied
Chronic Ischemic Heart Disease
ICD-10 code
I25
ICD-10 code description
Chronic ischaemic heart disease
2
Description of health condition studied
Acute Renal Failure with tubular necrosis
ICD-10 code
N17.0
ICD-10 code description
Acute renal failure
Primary outcomes
1
Description
urinary NGAL
Timepoint
2 TIMES2 TIMES(after urinary caheterizaion, and 2 hours after arrival at the intensive care unit)
Method of measurement
ELISA
Secondary outcomes
1
Description
serum creatinin
Timepoint
daily for 4 days
Method of measurement
laboratory equipment
2
Description
intubation time
Timepoint
from entry to ICU till extubation
Method of measurement
hour
3
Description
blood product requirement
Timepoint
during operation
Method of measurement
unit
4
Description
chest tube drainage
Timepoint
from entry to ICU till chest tube removal
Method of measurement
ml
Intervention groups
1
Description
They will be randomly assigned to either an ultrafiltration group (n=100) or to a control group (n=100). Ultrafiltration (Hemocor HPH 1400) will be done during cardiopulmonary bypass (40cc/kg).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiac Surgery Ward- M odarres Hospital
Full name of responsible person
Mahnoosh Foroughi
Street address
Saadat Abad.Modarres Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urology and Nephrology Research Center
Full name of responsible person
Dr. Shabnam Golshan
Street address
Urology and Nephrology Research Center- aside Labbafi Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology and Nephrology Research Center
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
Modarres Hospital
Full name of responsible person
Mahnoosh Foroughi
Position
Cardiac Surgeon
Other areas of specialty/work
Street address
Modarres Hospital.Saadat Abad- Tehran
City
Tehran
Postal code
Phone
+98 21 2236 0635
Fax
+98 21 2236 0635
Email
m_foroughi@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Clinical Research and Development Center
Full name of responsible person
Mahnoosh Foroughi
Position
Cardiac Surgeon
Other areas of specialty/work
Street address
Modarres Hospital. Saadat abad
City
Tehran
Postal code
Phone
+98 21 2236 0635
Fax
+98 21 2236 0635
Email
m_foroughi@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Clinical Developement and ResearchCenter
Full name of responsible person
Mahnoosh Foroughi
Position
Cardiac Surgeon
Other areas of specialty/work
Street address
Modarres Hospital.Saadat abad
City
Tehran
Postal code
Phone
+98 21 2236 0635
Fax
+98 21 2236 0635
Email
m_foroughi@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)