Comparison of protective effects of N-acetyl cysteine and vitamin C on perioperative renal function in high-risk patients undergoing cardiac bypass surgery.
Perioperative renal failure is one of the major complications following coronary artery surgeries, leading to increased morbidity and mortality rate in patients, necessitating renal replacement therapy and longer hospital and ICU stay. With regard to antioxidant effect of N-acetyl cysteine (NAC) and vitamin C in decreasing inflammatory factors, this study was designed to evaluate and compare the protective effects of these two agents on renal function of high-risk patients undergoing coronary artery surgeries. In this study, 84 patients above 70 years old, undergoing cardiac bypass surgery, who are considered as high-risk regarding postoperative renal failure are randomized into 3 groups; group 1 are received NAC, group 2 are received NAC plus vitamin C and group 3 are received normal saline(NS) 5% as placebo. The agents re administered during, 12 and 24 hours after the operation. Serum creatinine levels one day before and the 1st, 2nd and 3rd days after operation are recorded and compared. Note that subjects experienced heart and kidney transplant are excluded from the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072815102N4
Registration date:2014-08-22, 1393/05/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-22, 1393/05/31
Registrant information
Name
Soheil Ashkani-Esfahani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 2033
Email address
ashkanis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research affairs, Shiraz University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of protective effects of N-acetyl cysteine and vitamin C on perioperative renal function in high-risk patients undergoing cardiac bypass surgery.
Public title
The effect of N-acetyl cysteine and vitamin C on kidney in patients undergoing open heart surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age above 70 years old; Renal failure; Serum Cr level above 1.4 mg/dl; Heart ejection fraction of below 35%; Concomitant valve surgery with bypass surgery; History of previous coronary artery surgeries; Diabetes under treatment with oral agents or insulin.
Exclusion criteria: The emergency cardiac bypass surgery; History of heart transplantation; Acute renal failure; Serum Cr level higher than 4.5 mg/dl; History of renal transplantation; N-acetyl cysteine consumption in the last 5 days prior to the operation.
Age
From 70 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Eighty four patients with coronary artery disease, who are selected for bypass surgery and considered high-risk regarding renal complications, are randomly divided into 3 groups. All groups are equal regarding their age averages. The intervention group1 is given N-acetyl cysteine, intervention group 2 is given N-acetyl cysteine plus vitamin C and control one is received placebo. Since the study was a double blind one, patients and surgical group do not know which one is medication and which one is placebo.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
School of Medical Sciences, Zand St.
City
Shiraz
Postal code
Approval date
2014-04-15, 1393/01/26
Ethics committee reference number
ct-p-9356-5306
Health conditions studied
1
Description of health condition studied
Renal failure
ICD-10 code
N17
ICD-10 code description
Acute renal failure
2
Description of health condition studied
coronary vessel disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerosis heart disease
Primary outcomes
1
Description
the effect of N-acetyl cysteine on kidney
Timepoint
the 1st, 2nd and 3rd day after surgery
Method of measurement
Serum creatinine level
2
Description
The effect of N-acetyl cysteine and vitamin C on kidney
Timepoint
the 1st, 2nd and 3rd day after surgery
Method of measurement
Serum creatinine levels
Secondary outcomes
1
Description
blood pressure
Timepoint
before surgery
Method of measurement
the peripheral blood pressure was measured with sphygmomanometer
2
Description
number of grafts
Timepoint
after surgery
Method of measurement
review of operation note
Intervention groups
1
Description
Intervention1: Acetyl cysteine (EXI-NACE, EXIR pharmaceuticals, Borujerd, Iran), 2gr/lit injectable ampule, 3ml, 4doses within 24 hours after surgery.
Category
Treatment - Drugs
2
Description
Intervention 2: placebo, 2gr/lit injectable ampule, 3ml, 4doses within 24 hours after surgery.
Category
Treatment - Drugs
3
Description
intervention3: vitamin C ( OSVE-VITAMIN C, Osve pharmaceuticals, Tehran, Iran), 500mg/5ml injectable ampule, 30 ml, 4 doses within 24 hours after surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
hospitals affiliated to Shiraz University of Medical Sciences
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research affairs, Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
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 affairs, Shiraz 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
Department of Anesthesiology and Student Research Committee
Full name of responsible person
Saeed Reza Soltani
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Faghihi Hospital, Zand St.
City
Shiraz
Postal code
Phone
+98 71 1634 1256
Fax
Email
saeedrezasoltani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of anesthesia, School of medicine, Shiraz University of Medical Sciences
Full name of responsible person
Ali Karami
Position
Anesthestetist
Other areas of specialty/work
Street address
Faghihi Hospital, Zand St.
City
Shiraz
Postal code
Phone
+98 71 1634 1256
Fax
Email
Alk1380@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Anesthesiology and Student Research Committee
Full name of responsible person
Saeed Reza Soltani
Position
Resident of anesthesiology
Other areas of specialty/work
Street address
Faghihi Hospital, Zand St.
City
Shiraz
Postal code
Phone
+98 71 1634 1256
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)