Back to resultsLimb Ischemic Preconditioning for Prevention of Contrast Media Induced Nephropathy in Diabetic Kidney Patient
Primary Purpose
Serum Cystatin C Before and After Coronary Angiogram, Serum Creatinine Before and After Coronary Angiogram
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
limb ischemic preconditioning
Sponsored by
About this trial
This is an interventional prevention trial for Serum Cystatin C Before and After Coronary Angiogram
Eligibility Criteria
Inclusion Criteria:
- Documented diabetic kidney disease
- Elective coronary angiogram
- Glomerular filtration rate < 60 ml/min by Cockroft-Gault or Modification of Diet in Renal Disease or CKD-EPI
Exclusion Criteria:
- Refuse or reject to inform consented
- Hemodynamic compromise (Heart failure, need for intraaortic balloon pump)
- Expose to drug or chemical substances potentially to be a nephrotoxic agent with in 1 mo (Not include preexisting Angiotensin converting enzyme inhibitor or Angiotensin receptor blocker with stable serum creatinine)
- Documented or suspected of peripheral arterial disease, upper or lower limb
- Bleeding diathesis
- Contraindicated for coronary angiogram
- currently on renal replacement therapy
Sites / Locations
- Ramathibodi HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Sham Comparator
Arm Label
limb ischemia
Arm Description
Outcomes
Primary Outcome Measures
kidney injury before and after coronary angiogram.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01763034
Brief Title
Limb Ischemic Preconditioning for Prevention of Contrast Media Induced Nephropathy in Diabetic Kidney Patient
Official Title
Limb Ischemic Preconditioning for Prevention of Contrast Media Induced Nephropathy in Diabetic Kidney Patient
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ramathibodi Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Contrast media induced nephropathy (CIN) is considered to be a serious complication in patient who underwent coronary angiogram (CAG). The pathogenesis of CIN does not well understood. The probable one is the contrast media makes the afferent vessel in glomeruli constrict and results in renal shut down. Limb ischemic preconditioning, a procedure that makes muscles become ischemic and adapt themselves to produce some cytokines for signaling the vessel more dilated. After the reperfusion, these cytokines are getting back to systemic circulation and effect the afferent vessel in glomeruli to become more dilated and prevent CIN.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Serum Cystatin C Before and After Coronary Angiogram, Serum Creatinine Before and After Coronary Angiogram
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
limb ischemia
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
limb ischemic preconditioning
Intervention Description
use a simple blood pressure cuff inflate for 5 minutes and deflate for 5 minutes alternately in each arms total = 3 cycle in each arm
Primary Outcome Measure Information:
Title
kidney injury before and after coronary angiogram.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented diabetic kidney disease
Elective coronary angiogram
Glomerular filtration rate < 60 ml/min by Cockroft-Gault or Modification of Diet in Renal Disease or CKD-EPI
Exclusion Criteria:
Refuse or reject to inform consented
Hemodynamic compromise (Heart failure, need for intraaortic balloon pump)
Expose to drug or chemical substances potentially to be a nephrotoxic agent with in 1 mo (Not include preexisting Angiotensin converting enzyme inhibitor or Angiotensin receptor blocker with stable serum creatinine)
Documented or suspected of peripheral arterial disease, upper or lower limb
Bleeding diathesis
Contraindicated for coronary angiogram
currently on renal replacement therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SIRAPAT POONVUTIKUL, MD
Phone
66891038796
Email
boybm027@hotmail.com
Facility Information:
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SIRAPAT POONVUTIKUL, MD
Phone
66891038796
Email
boybm027@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Limb Ischemic Preconditioning for Prevention of Contrast Media Induced Nephropathy in Diabetic Kidney Patient
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