Contrast Induced Acute Kidney Injury
Conditions
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.
Interventions
PROCEDURERemote ischemic preconditioning
Appropriately sized sphygmomanometer cuff placed around right upper arm; where contraindicated, left arm, with inflation of the cuff up to 200mmHg for 5 minutes, followed by deflation of 5 minutes to allow reperfusion with cycle repeated 3 times.
PROCEDURESham ischemic preconditioning
Appropriately sized sphygmomanometer cuff placed around right upper arm; where contraindicated, left arm, with inflation of the cuff up to 50mmHg for 5 minutes, followed by deflation of 5 minutes to allow reperfusion with cycle repeated 3 times.
Sponsors
Ulsan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Relative change in serum creatinine from baseline | 72 hours | Defined as a change in serum value from baseline |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Periprocedural myocardial infarction | 24 hours | Defined as Trop T or CKMB levels \>3 times the upper limit of normal |
Countries
South Korea
Outcome results
None listed