Remote Ischemic Preconditioning as a Method Against Subclinical Renal Injury and Contrast-induced Nephropathy
NCT02700958 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2018-05-17
Summary
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.
Conditions
- Atherosclerosis
- Stable Angina
- Peripheral Artery Disease
- Contrast-induced Nephropathy
Interventions
- PROCEDURE
-
Remote ischemic preconditioning
Remote ischemic preconditioning is performed with standard blood pressure cuff on upper-arm. RIPC will be started just before the coronarography or angiography. Time between the last inflation cycle and the beginning of the procedure will be less than 60 minutes.
- PROCEDURE
-
SHAM Remote ischemic preconditioning
SHAM Remote ischemic preconditioning is performed with standard blood pressure cuff on upper-arm. RIPC-SHAM will be started just before the coronarography or angiography. Time between the last inflation cycle and the beginning of the procedure will be less than 60 minutes
Sponsors & Collaborators
-
Tartu University Hospital
lead OTHER
Principal Investigators
-
Jaan Eha, MD, PhD · Tartu University Hospital
-
Jaak Kals, MD, PhD · Tartu University Hospital
-
Mihkel Zilmer, MD, PhD · University of Tartu
-
Karl Kuusik, MD · University of Tartu
-
Teele Kepler, MD · University of Tartu
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-02-29
- Primary Completion
- 2018-03-19
- Completion
- 2019-03-19
Countries
- Estonia
Study Locations
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