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

• Sponsor: Ramathibodi Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01763034
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1
• Duration (Months): 12.9
• Patients Per Site Per Month: 15.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Serum Cystatin C Before and After Coronary Angiogram; Serum Creatinine Before and After Coronary Angiogram	Procedure: limb ischemic preconditioning	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• 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
• Study Start Date: Feb 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2013
• Anticipated Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. kidney injury before and after coronary angiogram. [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	Ramathibodi Hospital	Bangkok		Thailand	10400

Sponsors and Collaborators

• Ramathibodi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sirapat Poonvutikul, Cardiology unit, Ramathibodi Hospital
• ClinicalTrials.gov Identifier: NCT01763034
• Other Study ID Numbers: RAMA-CIN01
• First Posted: Jan 8, 2013
• Last Update Posted: Apr 23, 2013
• Last Verified: Apr 1, 2013

• Additional relevant MeSH terms: Kidney Diseases

Study Results

No Results Posted as of Apr 23, 2013