Remote Ischemic Preconditioning as a Method Against Subclinical Renal Injury and Contrast-induced Nephropathy

Tartu University Hospital

Status: Completed

Conditions: Peripheral Artery Disease; Stable Angina; Contrast-induced Nephropathy; Atherosclerosis

Treatments: Procedure: SHAM Remote ischemic preconditioning; Procedure: Remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT02700958

16003

Details and patient eligibility

About

Contrast-induced nephropathy (CIN) has remained significant and severe complication of angiographic procedures despite the increasing use of preventative methods. It has been associated with prolonged hospital stay, high morality and the need for dialysis. Since classically used creatinine for diagnosing of CIN does not reflect the degree of tubular injury before 24-48 hours after exposure to contrast media alternative earlier biomarkers and preventative methods are needed. Remote ischemic preconditioning is a non-invasive and safe method which in some studies has been reported to protect against contrast-induced nephropathy. The purpose of this study is to evaluate the effect of remote ischemic preconditioning (RIPC) (1) as an additional method to standard treatment to prevent subclinical and clinical contrast-induced acute kidney injury and (2) to assess its effect on functional properties of arterial wall, organ damage biomarkers and low molecular weight metabolites.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than 18 years, no upper age limit
• Patients with stable coronary artery disease (II - III class according to the Canadian Cardiovascular Society) hospitalized for coronarography or with lower extremity arterial disease hospitalized for angiography
• Written informed consent

Exclusion criteria

• Pregnancy
• Age less than 18 years
• eGFR < 30 ml/min/1,73 m2
• Simultaneous participation in an other clinical trial
• Coexisting pathology of the upper-limbs limiting the use of the cuff (bilateral amputee, recent trauma, chronic ulcers, significant upper limb peripheral atherosclerosis (radial pulse not palpable on either side))
• Malignant tumor (in remission less than 5 years or ongoing treatment)
• Documented allergic reaction to iodinated contrast agent
• Acute infection (body temperature 38 degrees Celsius or higher, c reactive protein 50mg/L or higher)
• Cardiac rhythm abnormalities (atrial fibrillation, frequent supraventricular premature complexes)
• Documented myocardial infarction within 30 days
• Inability to understand the instructions of the study
• Vascular surgery in axillary region
• Unable to lie supine for 40 minutes
• Home oxygen treatment
• Documented upper limb deep vein thrombosis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups

Remote ischemic preconditioning

Experimental group

Description:

Remote Ischemic Preconditioning (RIPC) is performed by inflating blood pressure cuff for 5-minutes at 200 mmHg, or if patients systolic blood pressure is higher than 200 mmHg 20 mmHg above systolic pressure, alternated with 5-minute deflation for 4 times.

Treatment:

Procedure: Remote ischemic preconditioning

SHAM remote ischemic preconditioning

Sham Comparator group

Description:

SHAM Remote Ischemic Preconditioning (RIPC-SHAM) is accomplished by alternating 4 cycles of 5-minute inflation with 5-minute deflation. Blood pressure cuff will be inflated to 10-20 mmHg. RIPC-SHAM is performed with standard blood pressure cuff on upper-arm.

Treatment:

Procedure: SHAM Remote ischemic preconditioning