Contrast-induced nephropathy reduction by remote ischemic preconditioning
Design
100 patients in the intervention group 45 minutes before angiography /angioplasty under induction ischemia with blood pressure cuff in the elbow area by inflating the cuff 50 mm Hg above systolic pressure in 5-minute for 4 cycles and emptying the cuff for 5 minutes between cycles with standard treatment And in the control group, 100 patients were randomly compared with standard creatinine only with standard treatment and inflated cuff pressure gauge of 10 mm Hg less than systolic pressure for contrast induced nephropathy with creatinine and eGFR baseline and 48 hours later.
Settings and conduct
100 patients in the intervention group 45 minutes before angiography / angioplasty under induction ischemia with blood pressure cuff in the elbow area by inflating the cuff 50 mm Hg above systolic pressure in 5-minute for 4 cycles and emptying the cuff for 5 minutes between cycles with standard treatment And in the control group, 100 patients were randomly compared with standard creatinine only with standard treatment and inflated cuff pressure gauge of 10 mm Hg less than systolic pressure in Dr. Shariati Hospital in Tehran.
If creatinine increases more than 0.5 mg /dL or eGFR decreases, more than 25% of contrast-induced nephropathy is considered.
Participants/Inclusion and exclusion criteria
Age over 18 years
Non-dialysis
Creatinine greater than 1.4 mg/dl or eGFR less than 60 cc/min
Conscious consent of the intervention type
Possibility of intervention
Intervention groups
1: Patients with creatinine ≥ 1.4 mg/dl or eGFR <60 ml/min with standard treatment and induction ischemia with blood pressure cuff
2: Patients with creatinine ≥ 1.4 mg/dl or eGFR <60 ml/min with standard treatment without induction ischemia with blood pressure cuff
Main outcome variables
Determination of incidence of contrast induced nephropathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200617047814N1
Registration date:2020-07-04, 1399/04/14
Registration timing:registered_while_recruiting
Last update:2020-07-04, 1399/04/14
Update count:0
Registration date
2020-07-04, 1399/04/14
Registrant information
Name
Seyed shafi shafipoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4044 8126
Email address
milad.shafipoor@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Remote Ischemic preconditioning effect for prevention of contrast-induced nephropathy in patients with coronary angiography/angioplasty
Public title
Remote Ischemic preconditioning effect for prevention of contrast-induced nephropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Cr > 1.4mg/dl or eGFR< 60 cc/min
Informed consent
Exclusion criteria:
hemodialysis or Peritoneal dialysis
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Patient block randomization is performed using the website www.randomization.com, and patient codes are generated with envelope letters in which the data is not clear, and each of the random questions generated is recorded on a single card and the card is inserted into the packet.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the method, none of the patients and angiography/angioplasty operators and researcher will be aware of patient coding and grouping.
The clinical caregiver performs the intervention in the intervention group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical sciences
Street address
pour sina Ave
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2020-03-17, 1398/12/27
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.002
Health conditions studied
1
Description of health condition studied
Contrast induced nephropathy
ICD-10 code
N99.0
ICD-10 code description
Postprocedural (acute) (chronic) kidney failure
Primary outcomes
1
Description
Cratinine
Timepoint
Before the procedure and 48 hours after the procedure
Method of measurement
blood test: based on mg/dl
2
Description
eGFR
Timepoint
Before the procedure and 48 hours after the procedure
Method of measurement
blood test: calculated by cockroft furmola
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, 45 minutes before angiography/angioplasty under induction ischemia with blood pressure cuff in the elbow area by inflating the cuff 50 mm Hg above systolic pressure in 5-minute for 4 cycles and 5-minute emptying between cycles with hydration. Standard treatment (hydration) is performed for all patients in the intervention and control group. If creatinine increases more than 0.5 mg / dL or eGFR decreases, more than 25% of contrast-enhanced nephropathy is considered.
Category
Prevention
2
Description
Control group: In the control group, 45 minutes before angiography / angioplasty, inflating the 10 mm Hg pressure gauge cuff is performed less than systolic pressure in the elbow area with standard treatment. If creatinine increases more than 0.5 mg / dL or eGFR decreases, more than 25% of contrast-enhanced nephropathy is considered.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shariati hospital
Full name of responsible person
Seyed Shafi Shafipoor
Street address
Dr. Shariati hospital, North Karegar Ave, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
milad.shafipoor@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
No. 6 floor, Central Organization of the University, Corner of Quds Street, Keshavarz Ave.
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8163 3685
Fax
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Seyed Shafi Shafipoor
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Dr. Shariati hospital, North Karegar Ave, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
milad.shafipoor@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Abdolhossein Tabatabaie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Dr. Shariati hospital, North Karegar Ave, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
tabatabaeiseyedah@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Shafi Shafipoor
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Dr. Shariati hospital, North Karegar Ave, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
milad.shafipoor@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
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people have not been identified.
When the data will become available and for how long
Immediately after the publication of the results.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Any analysis is allowed.
From where data/document is obtainable
seyed shafi shafipoor
milad.shafipoor@gmail.com
What processes are involved for a request to access data/document
If the article is published, the data will be given as soon as possible after the request.