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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Ramathibodi Hospital
Sponsor:
Information provided by (Responsible Party):
Sirapat Poonvutikul, Ramathibodi Hospital
ClinicalTrials.gov Identifier:
NCT01763034
First received: December 23, 2012
Last updated: April 22, 2013
Last verified: April 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 Ramathibodi Hospital:

Primary Outcome Measures:
  • kidney injury before and after coronary angiogram. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sirapat Poonvutikul, Cardiology unit, Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT01763034     History of Changes
Other Study ID Numbers: RAMA-CIN01
Study First Received: December 23, 2012
Last Updated: April 22, 2013
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014