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

NCT ID: NCT01763034

Last Updated: 2013-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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limb ischemia

Group Type SHAM_COMPARATOR

limb ischemic preconditioning

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ramathibodi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sirapat Poonvutikul

Cardiology unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ramathibodi Hospital

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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SIRAPAT POONVUTIKUL, MD

Role: CONTACT

66891038796

Facility Contacts

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SIRAPAT POONVUTIKUL, MD

Role: primary

66891038796

Other Identifiers

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RAMA-CIN01

Identifier Type: -

Identifier Source: org_study_id

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