(1) Objectives:Renal failure is a frequent event after coronary artery bypass grafting (CABG). Hemodynamic alterations that occur during surgery as well as the underlying disease are the predisposing factors. So we aimed to study intermittent furosemide therapy in the prevention of renal failure in patients undergoing CABG.
(2) Design:]n a double blind randomized controlled trial, 123 patients, aged18 to 75, candidate for elective CABG will enter the study.
(3) Setting and conduct: Renal function will be assessed by measuring the clearance of creatinine, urea and water.
(4) Participants including major eligibility criteria: patients aged18 to 75, candidate for elective CABG will enter the study.
Inclusion criteria:
age 40-75;
elective CABG with CPB;
constant surgeon;
informed written consent;
Exclusion criteria:
old age above 75 years;
emergency surgery;
high risk surgery;
ischemic heart disease;
diabetes mellitus;
diabetic ketoacidosis;
non-ketonic hyperosmolar diabetic coma;
acute renal failure;
chronic kidney disease causing serum Cr>2mg/dL;
glomerulonephritis;
hepatic failure causing liver function test failure (> 3 times than normal);
off pump CABG;
any unwanted complication in the operation period;
re-starting CPB after weaning from bypass;
pulmonary artery pressure >30 before operation;
ejection fraction<30%;
re-operation in the postoperative period;
congestive heart failure;
thyroid disorders;
acute infections;
stroke;
pregnancy;
hospital admission in the recent 3 months;
(5) Intervention: The patients will be randomly assigned into 3 groups: group A (furosemide in the prime) 0.3-0.4 mg/Kg furosemide in the priming volume. Group B (intermittent furosemide) the patients receive 0.2 mg/kg furosemide during CABG if there will be a decrease in urinary excretion rate. Group C will be the control group in which the patients will not receive furosemide or any other drug as renal failure prophylaxis.
(6) main outcome measures (variables): Glomerular filtration rate (GFR) will be measured using Cockcroft-Gault formula.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502122804N8
Registration date:2015-06-04, 1394/03/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-04, 1394/03/14
Registrant information
Name
Ali Dabbagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2572
Email address
alidabbagh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2008-12-31, 1387/10/11
Expected recruitment end date
2009-12-31, 1388/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intermittent furosemide therapy as a prophylaxis of acute renal failure in CABG patients: is it effective?
A clinical trial
Public title
Intermittent furosemide therapy as a prophylaxis of acute renal failure in CABG patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age 40-75;
elective CABG with CPB;
constant surgeon;
informed written consent;
Exclusion criteria:
old age above 75 years;
emergency surgery;
high risk surgery;
ischemic heart disease;
diabetes mellitus;
diabetic ketoacidosis;
non-ketonic hyperosmolar diabetic coma;
acute renal failure;
chronic kidney disease causing serum Cr>2mg/dL;
glomerulonephritis;
hepatic failure causing liver function test failure (> 3 times than normal);
off pump CABG;
any unwanted complication in the operation period;
re-starting CPB after weaning from bypass;
pulmonary artery pressure >30 before operation;
ejection fraction<30%;
re-operation in the postoperative period;
congestive heart failure;
thyroid disorders;
acute infections;
stroke;
pregnancy;
hospital admission in the recent 3 months;
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
123
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
a tertiary level, referral university hospital
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rajaei Heart Center Research Ethics Comittee
Street address
Research Deputy, Rajaei Heart Center, Vali Asr Ave
City
Tehran
Postal code
1996911151
Approval date
2010-04-20, 1389/01/31
Ethics committee reference number
89/2
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
postoperative serum markers of renal function including Glomerular Filtration Rate (GFR)
Timepoint
Preoperative levels and also early postoperative period (mainly 24 hours)
Method of measurement
level of serum markers; then using the Cockcroft-Gault formula
Secondary outcomes
1
Description
acid-base and electrolytes of the plasma
Timepoint
before the intervention and 24 hours after intervention
Method of measurement
serum levels of markers
Intervention groups
1
Description
2. group B: intermittent furosemide therapy;
these patients received 0.2 mg/kg furosemide during CABG only in the case of decreased urinary excretion rate below the determined level in the study
Category
Treatment - Drugs
2
Description
1. group A: intra-prime furosemide therapy; these patients received 0.3-0.4 mg/kg furosemide in the prime solution
Category
Treatment - Drugs
3
Description
3. group C: the control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Heart Center
Full name of responsible person
Ali Dabbagh
Street address
Rajaei Heart Center, Next to Mellat Park, Niayesh Exp Way, Vali Asr Ave, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Rajaei Heart Center
Full name of responsible person
Dr Majid Maleki
Street address
Rajaei Heart Center, Next to Mellat Park, Niayesh Exp Way, Vali Asr Ave, Tehran, Iran
City
Tehran
Grant name
ندارد
Grant code / Reference number
None
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Rajaei Heart 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
Anesthesiology Research Center
Full name of responsible person
Ali Dabbagh
Position
Professor
Other areas of specialty/work
Street address
Anesthesiology Research Center, Velenjak, Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
1985717443
Phone
+98 21 2243 2572
Fax
Email
alidabbagh@yahoo.com: alidabbagh@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology Research Center
Full name of responsible person
Ali Dabbagh
Position
MD, Professor of Cardiac Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Research Center, Velenjak, Chamran Exp Way, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 2243 2572
Fax
+98 21 2243 2572
Email
alidabbagh@yahoo.com; alidabbagh@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology Research Center
Full name of responsible person
Ali Dabbagh
Position
MD, Professor of Cardiac Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Research Center, Ayatollah Taleghani Hospital, Velenjak, Chamran Exp Way
City
Tehran
Postal code
1985717443
Phone
+98 21 2243 2572
Fax
Email
alidabbagh@yahoo.com; alidabbagh@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)