Effect of Remote Ischemic Preconditioning on the Incidence of Acute Kidney
Injury in Patients Undergoing Coronary Artery Bypass Graft Surgery: A
Randomized Controlled Trial
Acute kidney injury (AKI), a common and serious complication of coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB), is associated with inflammatory reactions and ischemia-reperfusion injury. Remote ischemic preconditioning (RIPC) which is transient ischemia and reperfusion of a limb, is reported to reduce the risk of CPB-associated myocardial and acute kidney injury, but uncertainty remains.
In this prospective, double-blind, randomized, controlled trial at the Namazi and Shahid Faghihi hospitals, Shiraz, Iran, 177 adult patients undergoing elective or urgent on-pump CABG surgery will be randomly assigned to either RIPC group (n=90) or control group (n=90). The patients in RIPC group will receive three cycles of 5 min ischemia and 5 min reperfusion in the upper arm after induction of anesthesia. We will place an uninflated cuff on the arm for 30 min in the control group. The primary end point is the incidence of acute kidney injury defined as an elevation of serum creatinine of ≥0.3 mg/dl or ≥50% within 72 h after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017110537254N1
Registration date:2017-11-09, 1396/08/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-09, 1396/08/18
Registrant information
Name
Sina Bagheri
Name of organization / entity
Shiraz Nephro Urology Research Center
Country
Iran (Islamic Republic of)
Phone
+98 71 3843 1004
Email address
bagherisi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellery for research affairs, Shiraz University of Medical Sciences
Expected recruitment start date
2013-11-02, 1392/08/11
Expected recruitment end date
2017-02-04, 1395/11/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Remote Ischemic Preconditioning on the Incidence of Acute Kidney
Injury in Patients Undergoing Coronary Artery Bypass Graft Surgery: A
Randomized Controlled Trial
Public title
Effect of Remote Ischemic Preconditioning on the Incidence of Acute Kidney
Injury in Patients Undergoing Coronary Artery Bypass Graft Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:
• Candidate cardiac surgical patients
• Elective or urgent on pump coronary artery bypass grafting (CABG)
• Age 18 to 85 years
• Signed informed consent
Exclusion Criteria:
• End-stage renal disease (receiving hemodialysis or glomerular filtration
rate <15 ml/min/1.73m2)
• Peripheral vascular disease
• Severe hepatic disease
• Planned off-pump surgery
• Pregnancy
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
clinicaltrials.gov
Secondary trial Id
NCT02981680
Registration date
2016-12-05, 1395/09/15
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Blvd.
City
Shiraz
Postal code
Approval date
2017-01-23, 1395/11/04
Ethics committee reference number
IR.SUMS.MED.REC.1395.61
Health conditions studied
1
Description of health condition studied
Acute kidney injury
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Remote ischemic preconditioning
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Coronary artery bypass graft surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Incidence of postoperative acute kidney injury (AKI)
Timepoint
Within the first 72 hours after surgery
Method of measurement
Defined as an elevation of serum creatinine of ≥0.3 mg/dl or ≥50% within 72 hours after surgery
Secondary outcomes
1
Description
Duration of hospital stay
Timepoint
Through hospital stay after surgery
Method of measurement
in days
2
Description
Duration of ICU stay
Timepoint
Through ICU stay
Method of measurement
in days
3
Description
All cause mortality
Timepoint
Through hospital stay after surgery
Method of measurement
number of observed cases
4
Description
requiring hemodialysis
Timepoint
Through hospital stay after surgery
Method of measurement
number of observed cases
5
Description
Postoperative liver function
Timepoint
Preoperatively and at 24 h post-surgery
Method of measurement
By measuring serum AST, ALT, T.bilirubin, and albumin
6
Description
Incidence of postoperative atrial fibrillation (AF)
Timepoint
Within the first 72 hours after surgery
Method of measurement
Defined as the incidence of new-onset AF lasting for five minutes or longer
7
Description
Incidence of postoperative stroke
Timepoint
Through hospital stay after surgery
Method of measurement
Defined as a new ischemic or hemorrhagic cerebrovascular accident with neurological deficit lasting >24 h
Intervention groups
1
Description
Intervention: RIPC
Patients in the remote ischemic preconditioning (RIPC) group will receive three sequential sphygmomanometer cuff inflations on their right upper arm after induction of anesthesia in the operating
room. The cuff will be inflated by the OR nurse up to 200 mmHg for five minutes each occasion, with five minutes deflation in between inflations. Following this
pre-conditioning phase, surgery will be started. The entire pre-conditioning phase will last 30 minutes.
Category
Prevention
2
Description
Control: sham-RIPC
Patients in the sham-RIPC group will have the sphygmomanometer cuff placed on their right upper arm, but the cuff will not be inflated. Similar to patients in the RIPC group, patients in the sham-RIPC group will undergo the same 30 minute delay before starting surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namzi Hospital
Full name of responsible person
Street address
City
Shiraz
2
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellery for research affairs, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand Blvd.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery 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
Shiraz nephro-urology research center
Full name of responsible person
Sina Bagheri
Position
M.D.
Other areas of specialty/work
Street address
Room No. 5, Floor 6, Mohammad Rasool Allah Research Tower, Khalili street, Mulla Sadra Blvd
City
Shiraz
Postal code
Phone
+98 71326281563
Fax
Email
bagherisi@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Nephro Urology Research Center
Full name of responsible person
Mohammad Mahdi Sagheb
Position
M.D.
Other areas of specialty/work
Street address
Room No. 5, Floor 6, Mohammad Rasool Allah Research Tower, Khalili street, Mulla Sadra Blvd
City
Shiraz
Postal code
Phone
+98 71326281563
Fax
Email
saghebm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Nephro Urology Research Center
Full name of responsible person
Sina Bagheri
Position
M.D.
Other areas of specialty/work
Street address
Room No. 5, Floor 6, Mohammad Rasool Allah Research Tower, Khalili street, Mulla Sadra Blvd
City
Shiraz
Postal code
Phone
+98 71326281563
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)