Evaluation of induced muscle ischemia on prevention of acute kidney injury based on serum cystatin-c in admitted patients undergoing coronary angiography
Evaluation of induced muscle ischemia on prevention of acute kidney injury based on serum cystatin-C in admitted patients undergoing coronary angiography
Design
A randomized (simple randomization), double-blinded, clinical trial with a parallel group design of 140 patients referred to Shahid Mohammadi Hospital who need coronary angiography.
Settings and conduct
patients will be randomly divided into two groups by using simple randomization method. in both groups, the pressure cuff is closed to the patient and in the treatment group, it is inflated up to 200 mm Hg and in the control group up to 20 mm Hg. Then the patients will undergo coronary angiography at Bandar-abbas Shahid mohammadi Hospital.In order to blind the analyzer, the persons responsible for executing Ischemic Preconditioning and data collection are different from the outcome assessors.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age equal to or greater than 18 years; patients who don’t use nephrotoxic drugs 72 hours before angiography; ejection fraction> 50%; no cardiogenic shock or recent cardiac infarction.
Exclusion criteria: patients who did not have consent to participate in the study; patients with renal dysfunction (GFR <60) based on KDIGO criteria; pregnant women; patients needing an emergency angiography.
Intervention groups
Intervention group: Remote Ischemic Preconditioning (RIPC) will be performed via the automated delivery of three cycles of 200 mm/Hg blood pressure cuff inflation for 5 min followed by cuff deflation for 5 min in the upper arm.
Control group: sham-RIPC will be done by three cycles of upper-limb pseudo ischemia (5-min cuff inflation to a pressure of 20 mmHg and 5-min cuff deflation).
Main outcome variables
Serum Creatinine; Estimated glomerular filtration rate; Serum Cystatin-C; Acute Kidney Injury according to the 2012 Kidney Disease: Improving Global Outcomes criteria.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180924041113N1
Registration date:2018-10-30, 1397/08/08
Registration timing:retrospective
Last update:2018-10-30, 1397/08/08
Update count:0
Registration date
2018-10-30, 1397/08/08
Registrant information
Name
Azadeh Moradkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3375 4950
Email address
azadeh.moradkhani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-06, 1396/08/15
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
2017-11-06, 1396/08/15
Actual recruitment end date
2018-06-20, 1397/03/30
Trial completion date
2018-06-20, 1397/03/30
Scientific title
Evaluation of induced muscle ischemia on prevention of acute kidney injury based on serum cystatin-c in admitted patients undergoing coronary angiography
Public title
Preventive Effect of induced muscle ischemia on acute kidney injury
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age equal to or greater than 18 years
Hospitalized patients requiring angiography
Patients who don’t use nephrotoxic drugs 72 hours before angiography
Ejection fraction (EF) > 50%
Patients without cardiogenic shock or recent cardiac infarction
Exclusion criteria:
Patients who did not have consent to participate in the study
Patients with renal dysfunction (glomerular filtration rate (GFR) <60) based on KDIGO criteria
Pregnant women
Patients needing an emergency angiography
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
140
Actual sample size reached:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: simple,
Unit of randomization: individual,
Tools used in randomization: table of random numbers,
Patients are randomly divided into two groups of case and placebo by the table derived from Random Allocation software and they are placed in their respective group specified by the software in the order of inclusion in the study. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC533876/)
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the patient, in both groups, the pressure cuff is closed to the patient and in the treatment group, it is inflated up to 200 mm Hg and in the control group up to of 20 mm Hg. In order to blind the analyzer, the persons responsible for executing Remote Ischemic Preconditioning (RIPC) and data collection are different from the outcome assessors.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Ethical committee of Hormozgan University of Medical Sciences, Shahid Mohammadi Hospital, Kuye Farhangian, Islamic Republic blvd
City
Bandare-abbas
Province
Hormozgan
Postal code
7919915519
Approval date
2017-11-05, 1396/08/14
Ethics committee reference number
HUMS.REC.1396.42
Health conditions studied
1
Description of health condition studied
Renal dysfunction
ICD-10 code
N17
ICD-10 code description
Acute kidney failure
Primary outcomes
1
Description
Serum Creatinine
Timepoint
Before intervention and after intervention daily for 2 days
Method of measurement
AutoAnalyzer
2
Description
Serum Cystatin-C
Timepoint
Before intervention and 24 hours after intervention
Method of measurement
The enzyme-linked immunosorbent assay (ELISA) kit
3
Description
Estimated glomerular filtration rate (eGFR)
Timepoint
Before intervention and after intervention daily for 2 days
Method of measurement
Glomerular filtration rate Equation
4
Description
Acute Kidney Injury (AKI)
Timepoint
After intervention daily for 2 days
Method of measurement
The 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Remote Ischemic Preconditioning (RIPC) performed via the automated delivery of three cycles of 200 mm Hg blood pressure cuff inflation for 5 min followed by cuff deflation for 5 min on the non-dominant arm
Category
Prevention
2
Description
Control group: sham-RIPC (Remote Ischemic Preconditioning) intervention induced by three cycles of upper-limb pseudo ischemia (low pressure: 5-min blood pressure cuff inflation to a pressure of 20 mmHg and 5-min cuff deflation)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiac centre of Shahid Mohammadi Hospital
Full name of responsible person
Azadeh Moradkhani
Street address
Shahid Mohammadi Hospital, Islamic Republic blvd.
City
Bandare-Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Email
mail@hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Teymour Aghamolayi
Street address
Deputy of research and technology, Shahid Mohammadi Hospital, Islamic republic Blvd
City
Bandare-abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 7193
Email
recearch@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Azadeh Moradkhani
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Shahid Mohammadi Hospital, Kuy e Farhangian, Islamic Republic Blvd
City
Bandare-abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3375 4950
Email
azadeh.moradkhani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hamidreza Samimagham
Position
Nephrologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Mohammadi Hospital, Kuy e Farhangian, Islamic Republic Blvd
City
Bandare-abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 7000
Email
samimagham@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Azadeh Moradkhani
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Shahid Mohammadi Hospital, Kuy e Farhangian, Islamic Republic Blvd
City
Bandare-abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 7000
Email
azadeh.moradkhani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All the patient's data can be shared with privacy in regard to patients name
When the data will become available and for how long
Start accessing 6 months after publishing the results.
To whom data/document is available
For scholars working in academic centers.
Under which criteria data/document could be used
It can be analyzed and printed by other people by mentioning the source.
From where data/document is obtainable
dr. Azadeh Moradkhani,00989121995157,azadeh.moradkhani@yahoo.com
What processes are involved for a request to access data/document
Upon authentication, data is provided to the individual.