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Clinical Trials/NCT01763034
NCT01763034UnknownNot Applicable

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

Ramathibodi Hospital2 sites in 1 country200 target enrollmentStarted: February 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
200
Locations
2
Primary Endpoint
kidney injury before and after coronary angiogram.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

kidney injury before and after coronary angiogram.

Time Frame: 1 year

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sirapat Poonvutikul

Cardiology unit

Ramathibodi Hospital

Study Sites (2)

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