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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
Information provided by (Responsible Party):
Sirapat Poonvutikul, Ramathibodi Hospital Identifier:
First received: December 23, 2012
Last updated: April 22, 2013
Last verified: April 2013
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01763034

Contact: SIRAPAT POONVUTIKUL, MD 66891038796

Ramathibodi Hospital Recruiting
Bangkok, Thailand, 10400
Contact: SIRAPAT POONVUTIKUL, MD    66891038796   
Sponsors and Collaborators
Ramathibodi Hospital
  More Information

Responsible Party: Sirapat Poonvutikul, Cardiology unit, Ramathibodi Hospital Identifier: NCT01763034     History of Changes
Other Study ID Numbers: RAMA-CIN01
Study First Received: December 23, 2012
Last Updated: April 22, 2013 processed this record on September 21, 2017