Objective: studying the effect of furosemide on Glomerular filtration rate (GFR) in cardiac surgery
Design: Prospective randomized clinical trial
Setting and conduct: Eighty adult patients candidate for elective cardiac surgery using cardiopulmonary bypass, randomly will be allocated in two furosemide and placebo groups (N=40). Preoperative plasma creatinine will be measured in all patients and GFR will be calculated. After induction of anesthesia, in furosmide group, furosmide infusion (2 milligram per hour) and in placebo group 2 milliliter 0.9 percent saline infusion will be started and will be continued up to 12 hours post operatively. Plasma creatinine will be measured in second and fifth post operative days and GFR will be calculated. At the end the plasma creatinine and GFR changes will be compared between two groups
Inclusion criteria: Patients between 18-60 Years olds who are candidate for elective cardiac surgery
Exclusion criteria: urgent surgery; redo surgery; Plasma creatinine more than 1.5 milligram per deciliter ; GFR less than 50 milliliter per minute; Left Ventricular EF less than 40 percent
Intervention: Starting infusion of furosmide infusion 2 milligram per hour after induction of anesthesia up to 12 hours post operatively
Outcome measures: Post to preoperative plasma creatinine and GFR changes
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706091127N1
Registration date:2014-09-22, 1393/06/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-22, 1393/06/31
Registrant information
Name
Eissa Bilehjani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3329 6124
Email address
bilehjanii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-09-06, 1393/06/15
Expected recruitment end date
2015-03-06, 1393/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of prophylactic Furosemide infusion on Glomerular filtration Rate (GFR) in adult cardiac surgery
Public title
Effect of Furosemide Kidney Function in adult cardiac surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: All Patients Between 18-60 Years Olds Who Are Candidate for Elective Cardiac Surgery
Exclusion Criteria: Urgent Surgery; Redo Surgeries; Plasma Creatinine >1.5 milligram per deciliter; GFR<50ml/min; Left Ventricular EF<40 percent
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Approval date
2014-05-05, 1393/02/15
Ethics committee reference number
9320
Health conditions studied
1
Description of health condition studied
Acute Post Operative Renal Failure
ICD-10 code
N17.9
ICD-10 code description
Acute Renal Failure, Unspecified
Primary outcomes
1
Description
Estimated Glomerular Filtration Rate
Timepoint
At Preoperative, Second and Fifth Post Operative Days
Method of measurement
On Line Glomerular Filtration Rate Calculator Using Plasma Creatinine by Cockcroft-Gault Formula
Secondary outcomes
1
Description
Plasma Creatinine Concentration
Timepoint
At Preoperative, Second and Fifth Post Operative Days
Method of measurement
In Hospital Laboratory (Milligram per deciliter)
Intervention groups
1
Description
Intervention group: After Anesthesia Induction, Intravenous Furosemide (Alborz Darou) Infusion 2 mg/h (100 mg in 50 cc of normal saline) Will Be Started And Continued up to 12 Hour Post Operatively
Category
Treatment - Drugs
2
Description
Control group: After Anesthesia Induction, NaCl 0.9% Infusion (2 ml/h) Will Be Started and Continued up to 12 Hour Post Operatively.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani Heart Hospital
Full name of responsible person
Eissa Bilehjani
Street address
Madani Heart Center, Daneshgah Street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
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 of Tabriz 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
Medicine faculty, Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleiman Pour
Position
Vice Chancellor for research of Tabriz University of Medical Sciences
Other areas of specialty/work
Street address
Tabriz Medicine faculty, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1336 4667
Fax
Email
soleimanpourh@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Eissa Bilehjani
Position
Assistant Professor in Anesthesiology
Other areas of specialty/work
Street address
Madani Heart Center, Daneshgah Street, Tabriz
City
Tabriz
Postal code
516615573
Phone
+98 41 1337 3950
Fax
Email
bilehjanii@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Eissa Bilehjani
Position
Assistant Professor in Anesthesiology
Other areas of specialty/work
Street address
Madani Heart Center, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1332 1454
Fax
Email
bilehjanii@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)