Comparing the effects of 5% albumin and 6% hydroxyethyl starch 130/0.4 on glomerular filtration rate and serum creatinine when used as priming solutions for cardiopulmonary bypass pump.
The aim of this study is Comparing the effects of 5% albumin and 6% hydroxyethyl starch 130/0.4 on glomerular filtration rate and serum creatinine when used as priming solutions for cardiopulmonary bypass pump.
Sixty adult patients undergoing coronary bypass graft heart surgery were randomly assigned to either the human albumin orhydroxyethyl starch group. Inclusion criteria: patients undergoing elective coronary artery bypass grafting; age between 30 - 60 . Exclusion criteria: chronic renal failure; cardiopulmonary by pass pomp time over 2 hours; Patients were underwent an emergency operation; infective endocarditis; preoperative coagulation disorder; liver insufficiency; a left ventricular ejection fraction of less than 50%; previous cardiac surgery; a hemoglobin level of less than 10 milligram per deciliter before surgery. 500 milliliter of 5% human albumin (human albumin group), N:30 or orhydroxyethyl starch 130/0.4 (starch group), N:30 were added to the priming solution of the Cardiopulmonary bypass pump circuit for each group, respectively. renal function variables included serum creatinine and glomerular filtration rate were measured preoperative and postoperative at 24, 48 and 72 hour.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015011620112N4
Registration date:2015-02-04, 1393/11/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-04, 1393/11/15
Registrant information
Name
Pooya Derakhshan
Name of organization / entity
Birjand Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 1410
Email address
pooya_derakhshan@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University Of Medical Sciences
Expected recruitment start date
2012-01-01, 1390/10/11
Expected recruitment end date
2014-09-01, 1393/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of 5% albumin and 6% hydroxyethyl starch 130/0.4 on glomerular filtration rate and serum creatinine when used as priming solutions for cardiopulmonary bypass pump.
Public title
Albumin Versus Hydroxyethyl Starch in Cardiopulmonary Bypass Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing elective coronary artery bypass grafting; age between 30 - 60 .
Exclusion criteria: chronic renal failure; cardiopulmonary by pass pomp time over 2 hours; Patients were underwent an emergency operation; infective endocarditis; preoperative coagulation disorder; liver insufficiency; a left ventricular ejection fraction of less than 50%; previous cardiac surgery; a hemoglobin level of less than 10 milligram per deciliter before surgery.
Age
From 30 years old to 60 years old
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
N:56, Ghafari Ave.
City
Birjand
Postal code
1973456783421589
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
1391-78-90
Health conditions studied
1
Description of health condition studied
Atherosclerotic heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
serum Creatinine
Timepoint
preoprative and every 24 houre to 72 hour postoperatively
Method of measurement
isotope dilution mass spectrometry
Secondary outcomes
1
Description
Glomerular filtration rate
Timepoint
preoperative and Every 24 hour to 72 hour postoperatively
Method of measurement
isotope dilution mass spectrometry
Intervention groups
1
Description
500 milliliter human albumin 5% as a priming solution of cardiopulmonary bypass pump.
Category
Treatment - Drugs
2
Description
500 milliliter 6% hydroxyethyl starch 130/0.4 as priming solution of cardiopulmonary bypass pump
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Hospital
Full name of responsible person
Pooya Derakhshan
Street address
Imam Reza Hostipal, Taleghani St.
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mahmood Hosssein Zadeh Maleki
Street address
Ghafari Ave.
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Taleghani St.
City
Birjand
Postal code
1974567321566549
Phone
00
Fax
+98 563222300
Email
pooyaderkh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Talegani St.
City
Birjand
Postal code
Phone
+98 563222600
Fax
Email
pooyaderakh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Taleghani St.
City
Birjand
Postal code
1974567894321132
Phone
00
Fax
+98 563222300
Email
pooyaderakh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)