Evaluation of protective effect of induced muscle ischemia on contrast induced acute kidney injury (CI-AKI) after cardiac angiography or Percutaneous Coronary Intervention (PCI) in cardiac patient admitted at Shahid Mohammadi hospital in 2017-2018
Evaluation of protective effect of induced muscle ischemia on contrast induced acute kidney injury (CI-AKI) after cardiac angiography or Percutaneous Coronary Intervention (PCI) in cardiac patients admitted to Shahid Mohammadi hospital in 2017-2018
Design
A randomized (simple randomization), double-blinded (patients and analyzers), clinical trial with a parallel group design of 140 patients referred to Shahid Mohammadi Hospital who need coronary angiography and PCI.
Settings and conduct
patients will be randomly divided into two groups of seventy. For randomization, we will use simple randomization method. The location is the cardiac center at Shahid Mohammadi hospital. Patients and outcomes analyzer are blinded.
Participants/Inclusion and exclusion criteria
People over 18 years old who will undergo elective angiography, no ill or pregnant, no renal dysfunction before the intervention.
Intervention groups
Eligible patients will be randomized to the RIPC treatment group or the control group. In the treatment group, 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 upper arm. In the control group, sham-RIPC intervention will be done by three cycles of upper-limb pseudo ischemia (low pressure: 5-min cuff inflation to a pressure of 20 mmHg and 5-min cuff deflation).
Main outcome variables
Serum Creatinine and Estimated glomerular filtration rate (eGFR); Urine Neutrophil gelatinase-associated lipocalin (NGAL); Acute Kidney Injury (AKI) according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180820040838N1
Registration date:2018-10-01, 1397/07/09
Registration timing:retrospective
Last update:2018-10-01, 1397/07/09
Update count:0
Registration date
2018-10-01, 1397/07/09
Registrant information
Name
Sanaz Soleymani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 3158
Email address
soleimani@hormozgan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
2016-11-21, 1395/09/01
Actual recruitment end date
2017-09-21, 1396/06/30
Trial completion date
2017-09-21, 1396/06/30
Scientific title
Evaluation of protective effect of induced muscle ischemia on contrast induced acute kidney injury (CI-AKI) after cardiac angiography or Percutaneous Coronary Intervention (PCI) in cardiac patient admitted at Shahid Mohammadi hospital in 2017-2018
Public title
Effect of induced muscle ischemia on kidney injury
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age equal or greater than 18 years
Hospitalized patients requiring angiography or PCI
Exclusion criteria:
Patients who did not have consent to participate in the study
Patients with renal dysfunction (GFR <60) based on KDIGO criteria
Pregnant patients
Patients who used nephrotoxic drugs 72 hours before angiography or PCI
Patients who needed an emergency angiography or PCI
Patients with cardiogenic shock, recent cardiac infarction or EF < 50%
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
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 such as table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study in which patients and outcomes analyzer are blinded.
In order to blind the patient, in both groups, it is said that RIPC protocol is being used. In order to blind the analyzer, the persons responsible for executing RIPC and data collection are different from the outcome assessors.
Placebo
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, Islamic Republic blvd.
City
Bandare-abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2017-11-05, 1396/08/14
Ethics committee reference number
HUMS.REC.1396.43
Health conditions studied
1
Description of health condition studied
Renal dysfunction
ICD-10 code
N17
ICD-10 code description
Acute renal failure
Primary outcomes
1
Description
Serum Creatinine
Timepoint
Before intervention and after intervention daily for 2 days
Before intervention and 6 hours 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
Modification of diet in renal diseases (MDRD) GFR Equation
4
Description
Acute Kidney Injury (AKI)
Timepoint
After intervention
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
Sanaz Soleymani
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
Hormozgan University of Medical Sciences
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
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
Sanaz Soleymani
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Islamic Republic Blvd
City
Bandare-abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Email
sanazsoleymani9262@gmail.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
Islamic Republic Blvd
City
Bandare-abbas
Province
Hormozgan
Postal code
7916643885
Phone
+98 76 3333 3280
Email
sanazsoleymani9262@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Sanaz Soleymani
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Islamic Republic Blvd.
City
Bandare-abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3158
Email
sanazsoleymani9262@gmail.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. Sanaz Soleymani, +98 917 367 9262, sanazsoleymani9262@gmail.com.
What processes are involved for a request to access data/document
Upon authentication, data is provided to the individual.