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Limb Ischemic Preconditioning for Prevention of Contrast Media Induced Nephropathy in Diabetic Kidney Patient

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Sirapat Poonvutikul, Ramathibodi Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01763034
First Posted: January 8, 2013
Last Update Posted: April 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sirapat Poonvutikul, Ramathibodi Hospital
  Purpose
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.

Condition Intervention
Serum Cystatin C Before and After Coronary Angiogram Serum Creatinine Before and After Coronary Angiogram Procedure: limb ischemic preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Limb Ischemic Preconditioning for Prevention of Contrast Media Induced Nephropathy in Diabetic Kidney Patient

Further study details as provided by Sirapat Poonvutikul, Ramathibodi Hospital:

Primary Outcome Measures:
  • kidney injury before and after coronary angiogram. [ Time Frame: 1 year ]

Estimated Enrollment: 200
Study Start Date: February 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: limb ischemia Procedure: limb ischemic preconditioning
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763034


Contacts
Contact: SIRAPAT POONVUTIKUL, MD 66891038796 boybm027@hotmail.com

Locations
Thailand
Ramathibodi Hospital Recruiting
Bangkok, Thailand, 10400
Contact: SIRAPAT POONVUTIKUL, MD    66891038796    boybm027@hotmail.com   
Sponsors and Collaborators
Ramathibodi Hospital
  More Information

Responsible Party: Sirapat Poonvutikul, Cardiology unit, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT01763034     History of Changes
Other Study ID Numbers: RAMA-CIN01
First Submitted: December 23, 2012
First Posted: January 8, 2013
Last Update Posted: April 23, 2013
Last Verified: April 2013