Contrast Induced Acute Kidney Injury Clinical Trial
Official title:
Remote Ischemic Preconditioning for the Prevention of Contrast-induced Acute Kidney Injury in Diabetic Patients Undergoing Percutaneous Coronary Intervention
NCT number | NCT02329444 |
Other study ID # | 2011-08-074 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2014 |
Est. completion date | March 2015 |
Verified date | April 2019 |
Source | Ulsan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Ulsan University Hospital | Ulsan |
Lead Sponsor | Collaborator |
---|---|
Ulsan University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Periprocedural myocardial infarction | Defined as Trop T or CKMB levels >3 times the upper limit of normal | 24 hours | |
Primary | Incidence of CI-AKI | defined as a creatinine rise of = 25% or an increase of > 0.5mg/dl from baseline within 48 hours after contrast exposure | 48 hours | |
Secondary | Relative change in NGAL levels from baseline | Defined as a change in serum NGAL value from baseline | 24 hours | |
Secondary | Absolute change in NGAL levels from baseline | Defined as a change in serum NGAL value from baseline | 24 hours | |
Secondary | Relative change in serum creatinine from baseline | Defined as a change in serum value from baseline | 72 hours |
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