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

NCT ID: NCT02700958

Last Updated: 2018-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2019-03-19

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Remote ischemic preconditioning

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.

Group Type: EXPERIMENTAL

Remote ischemic preconditioning

Intervention Type: PROCEDURE

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.

SHAM remote ischemic preconditioning

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.

Group Type: SHAM_COMPARATOR

SHAM Remote ischemic preconditioning

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tartu University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jaak Kals

Tartu University Hospital, Clinic of Surgery, Department of Vascular Surgery, cardiovascular surgeon; MD-PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaan Eha, MD, PhD

Role: STUDY_CHAIR

Tartu University Hospital

Jaak Kals, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tartu University Hospital

Mihkel Zilmer, MD, PhD

Role: STUDY_CHAIR

University of Tartu

Karl Kuusik, MD

Role: STUDY_DIRECTOR

University of Tartu

Teele Kepler, MD

Role: STUDY_CHAIR

University of Tartu

Locations

Tartu University Hospital

Tartu, Tartu County, Estonia

Countries

Estonia

References

Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.

Reference Type: DERIVED

PMID: 36645250 (View on PubMed)

Other Identifiers

16003

Identifier Type: -

Identifier Source: org_study_id