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

M

Mahidol University

Status

Unknown

Conditions

Serum Creatinine Before and After Coronary Angiogram
Serum Cystatin C Before and After Coronary Angiogram

Treatments

Procedure: limb ischemic preconditioning

Study type

Interventional

Funder types

Other

Identifiers

NCT01763034
RAMA-CIN01

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

200 participants in 1 patient group

limb ischemia
Sham Comparator group
Treatment:
Procedure: limb ischemic preconditioning

Trial contacts and locations

1

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Central trial contact

SIRAPAT POONVUTIKUL, MD

Data sourced from clinicaltrials.gov

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