Acute renal failure (ARF) is one of the most serious complications of cardiac surgery that needs to be investigated. This is a pilot study on 30 adult patients who will undergo an isolated cardiac surgery (CABG). Excluding criteria are as follows: 1- Renal failure; 2- Hepatic failure; 3-History of gastrointestinal bleeding or Central nervous system hemorrhage; 4- Severe Arrhythmia; 5-Persistant hypotension; 6- Recent corticosteroid therapy; 7-Methylxanthine treatment; 8-Severe coagulopathies; 9-Uncontrolled diabetes mellitus; 10- Sepsis; 11-Active urinary tract infection; 12 Angiography in the past 7 days; 13-Treatment with Diltiazem or Nitroprusside; 14-Collagen vascular disease. Selected patients who meet our criteria will be randomly divided into case and control groups after taking an informed consent from them. In the case group, Pentoxyphiline is given 5 mg/kg as an I.V. bolus before anesthesia followed by a 1.5 mg/kg/h infusion for 3 hours after operation. Normal saline is given to the control group as a placebo. A urine specimen is taken via catheter after anesthesia and 3 and 24 hours following operation. Urine level of Neutrophil Gelatinase-Associated Lipocalin (NGAL) will be measured using ELISA method. Serum creatinine and CRP and urine creatinine will be measured before and 3 and 24 hours after operation. Demographic information, EuroSCORE and risk factors will be collected from all patients. After data analysis, the effect of Pentoxyphiline on reducing ARF will be surveyed. It is thought that Pentoxyphiline could reduce the incidence of acute kidney injury following open heart surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807302622N1
Registration date:2010-05-25, 1389/03/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-05-25, 1389/03/04
Registrant information
Name
Khosro Barkhordari
Name of organization / entity
Tehran Heart Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9600
Email address
kbarkhordari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran Heart Center - Dr. Abasali Karimi
Expected recruitment start date
2010-01-01, 1388/10/11
Expected recruitment end date
2010-07-01, 1389/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Eveluating the effect of Pentoxyphiline on Urinary Neutrophil Gelatinase-Associated Lipocalin after cardiac surgery
Public title
Effect of Pentoxyphiline on preventing acute kidney injury after cardiac surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Adultpatients who underwent coronary artery bypass graft surgery with a definite indication.
Exclusion criteria:
1- Renal failure; 2- Hepatic gailure; 3-History of gasterointestinal bleeding or Central nervous system hemorrhage; 4- Severe Arrhythmia; 5-Persistant hypotension; 6- Recent corticosteroid therapy; 7-Methylxanthine treatment; 8-Severe coagulopathies; 9-Uncontrolled diabetes mellitus; 10- Sepsis; 11-Active urinary tract infection; 12 Angiography in the past 7 days; 13-Treatment with Diltiazem or Nitroprusside; 14-Collagen vascular disease.
Age
From 18 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Heart Center
Street address
North Kargar ave
City
Tehran
Postal code
1411713138
Approval date
2009-12-28, 1388/10/07
Ethics committee reference number
382
Health conditions studied
1
Description of health condition studied
Acute Renal Failure
ICD-10 code
N17.9
ICD-10 code description
Acute Renal Failure, unsepecified
Primary outcomes
1
Description
NGAL reduction
Timepoint
3 and 24 hour following operation
Method of measurement
Blood test
Secondary outcomes
1
Description
decreasing renal failure
Timepoint
24 hours after operation
Method of measurement
Serum creatinine level every 24 hours post operation
Intervention groups
1
Description
injection of Pentoxiphyline: 5mg/kg stat bolus, 1.5 mg/kg continuous infusion for 3 hours
Category
Treatment - Drugs
2
Description
Injecting placebo: Normal saline 100 cc stat bolus + 100 cc 3-hours infusion
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Dr. Khosrow Barkhordari
Street address
North Kargar Ave. Before Jalal-e Al Ahmad highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Saeed Sadeghian
Street address
North Kargar Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran HEart Center
Full name of responsible person
Dr. Khosro Barkhordari
Position
Anesthesiologist
Other areas of specialty/work
Street address
North Kargar Ave. Before Jalal-e Al Ahmad highway
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
Email
kbarkhordari@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Khosrow Barkhordari
Position
Anesthesiologist
Other areas of specialty/work
Street address
North Kargar Ave. Before Jalal-e Al Ahmad highway
City
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
Email
karkhordari@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)