The Effect of Remote Ischemic Preconditioning on Elective Percutaneous Coronary Intervention in Diabetic Nephropathy
- Conditions
- Contrast Induced Acute Kidney Injury
- Interventions
- Procedure: Remote ischemic preconditioningProcedure: Sham ischemic preconditioning
- Registration Number
- NCT02329444
- Lead Sponsor
- Ulsan University Hospital
- Brief Summary
Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of contrast media use associated with prolonged hospitalization, cardiovascular events, persistent kidney damage and increased risk of all-cause mortality. When remote ischemic preconditioning is applied before percutaneous coronary intervention (PCI), the kidneys can be protected against ischemia-reperfusion injury and subsequently CI-AKI. In this randomised controlled trial, diabetic nephropathy patients undergoing PCI as part of their assessment and treatment of cardiovascular disease are randomized to receive RIPC or control sham preconditioning.
- Detailed Description
Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of contrast media use associated with prolonged hospitalization, cardiovascular events, persistent kidney damage and increased risk of all-cause mortality. Diabetes with pre-existing renal disease can increase the risk of CI-AKI. Remote ischemic preconditioning (RIPC) is a non-pharmacological strategy inducing transient episodes of ischemia by the occlusion of blood flow in non-target tissue such as a limb, before a subsequent prolonged ischemia-reperfusion injury occurs in a more distant organ. These brief, repeated ischemic episodes in the limb can confer a protection at more remote sites such as the heart, brain, lung, kidney, intestine or skeletal muscle. In a recent pilot study, using RIPC prior to coronary angiography in high risk patients with moderate chronic kidney disease, the authors found that RIPC significantly reduced the incidence of CI-AKI (Er et al Circulation. 2012;126(3),296). We hypothesized that RIPC would be protective as an adjunctive therapy in reducing the incidence of CI-AKI in diabetics with pre-existing CKD. This prospective study was performed to evaluate the efficacy of RIPC for the prevention of CI-AKI among diabetic nephropathy patients undergoing percutaneous coronary intervention.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Informed written consent
- All of the following:
- Known diagnosis of Type 2 diabetes
- NSTEMI, unstable or stable angina
- Patients undergoing elective coronary angiography and/or percutaneous coronary intervention
- eGFR < 60 mls/min or ACR > 300 mg/dl
- STEMI
- decompensated heart failure in the preceding 6 months
- patients with underlying end stage renal disease on maintenance dialysis
- recent (in the last 3 months) cerebrovascular disease
- chronic liver disease
- chronic obstructive pulmonary disease
- gastrointestinal bleeding
- acute or chronic infection or malignancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remote Ischemic Preconditioning Remote ischemic preconditioning Patients treated with Remote Ischemic Preconditioning Sham ischemic preconditioning Sham ischemic preconditioning Patients treated with sham ischemic preconditioning
- Primary Outcome Measures
Name Time Method Incidence of CI-AKI 48 hours defined as a creatinine rise of ≥ 25% or an increase of \> 0.5mg/dl from baseline within 48 hours after contrast exposure
- Secondary Outcome Measures
Name Time Method Relative change in NGAL levels from baseline 24 hours Defined as a change in serum NGAL value from baseline
Absolute change in NGAL levels from baseline 24 hours Defined as a change in serum NGAL value from baseline
Relative change in serum creatinine from baseline 72 hours Defined as a change in serum value from baseline
Trial Locations
- Locations (1)
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of