Interest of Remote Ischemic Preconditioning for Prevention of Contrast Medium-induced Nephropathy in High Risk Patients

NCT02470247 | Completed

• 4 other identifiers: 35RC14_9899_IPC-Angio Trial150058B-1115/07-9692015-A00076-43
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Diagnostic imaging for vascular investigations and endovascular procedures frequently require the use of contrast medium. Besides contrast medium-induced hypersensitivity, an acute kidney injury can appear: the contrast-induced nephropathy (NPCI). NPCI is associated with an increase of patients' morbidity and mortality. One of the conventional methods proposed to limit this NPCI is an oral administration of N-acetylcysteine (NAC) associated with hydration performed 12 hours before and 12 hours after the injection. However, in some patients this method cannot be performed due to a high risk of heart failure although they are generally at high risk of NPCI. Recently, it has been shown, in a randomized trial, that remote ischemic preconditioning (several cycles of upper-arm ischemia-reperfusion with a pressure cuff inflator) associated with hydratation and NAC reduced the occurrence of NPCI after a coronary angiography as compared with NAC and hydration only. . We hypothesized that the use of RIPC in patients at high risk of NPCI and who cannot receive NAC and hydratation (e.g. patients with aortic stenosis and eligible for Transcatheter Aortic Valve Implantation (TAVI)) could be promising.

Conditions

Nephropathy

Keywords

Transcatheter Aortic Valve Implantation

Outcome Measures

Primary Outcomes (1)

• Incidence of NPCI

  Incidence of NPCI defined as an increase in serum creatinine ≥ 0.5 mg / dL or a relative increase of 25 % above baseline at 48 hours after contrast medium exposure.

  48 hours

Secondary Outcomes (5)

• Cystatin C

  2 days

• Oxydative stress

  24 hours

• Renal function

  6 days

• Pain

  Day 0

• Mortality

  6 months

Study Arms (2)

Remote ischemic preconditioning

EXPERIMENTAL

Remote Ischemic Preconditioning (RIPC) is accomplished by performing 4 cycles of alternating 5-minute inflation and 5-minute deflation of a standard upper-arm blood pressure cuff, to induce transient and repetitive arm ischemia and reperfusion. RIPC will be started just before the CTA, and the time between the last inflation cycle and the beginning of the CTA will be less than 45 minutes.

Other: Remote Ischemic Preconditioning (RIPC)

SHAM remote ischemic preconditioning

SHAM COMPARATOR

The SHAM Remote Ischemic Preconditioning ("SHAM" RIPC) will be carried out with the same number of cycles that the RIPC but cuff will be inflated to the diastolic pressure of the subject and the cuff will be deflated to10 mmHg in order to maintain a non- ischemic compression (blind patient protocol).

Other: SHAM Remote Ischemic Preconditioning (SHAM RIPC)

Interventions

Remote Ischemic Preconditioning (RIPC) OTHER

RIPC is accomplished by performing 4 cycles of alternating 5-minute inflation and 5-minute deflation of a standard upper-arm blood pressure cuff, to induce transient and repetitive arm ischemia and reperfusion. RIPC will be started just before the CTA, and the time between the last inflation cycle and the beginning of the CTA will be less than 45 minutes.

Remote ischemic preconditioning

SHAM Remote Ischemic Preconditioning (SHAM RIPC) OTHER

The SHAM Remote Ischemic Preconditioning ("SHAM" RIPC) will be carried out with the same number of cycles that the RIPC but cuff will be inflated to the diastolic pressure of the subject and the cuff will be deflated to10 mmHg in order to maintain a non- ischemic compression (blind patient protocol).

SHAM remote ischemic preconditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years, no upper age limit ;
• Patient which may hospitalized for a medical check-up before a percutaneous aortic valve implantation (CTA and coronarography);
• Patient at risk for NPCI defined by a Mehran risk classification system ≥11 (Annexe 2) ;
• Willing to provide free and informed written consent

You may not qualify if:

• Pathology of the upper-limbs limiting the use of the cuff (bilateral amputation, arteriovenous fistula);
• Critical renal disease requiring hemodialysis ;
• Person who is not affiliated to a health care system insurance
• Inability to understand the instructions of the study;
• Absolute contraindication to of iodinated contrast medium injection (anaphylactic shock history to contrast media, especially Xenetix, clearance (MDRD) less than 30mL/min/1.73m2) ;
• Pregnancy
• Simultaneous participation in other protocol;
• Person with legal protection, person deprived of liberty.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, Britanny, 35033, France

Location

Related Publications (2)

• Belabbas D, Koch C, Chaudru S, Lederlin M, Laviolle B, Le Pabic E, Boulmier D, Heautot JF, Mahe G. Effects of Remote Ischemic Pre-Conditioning to Prevent Contrast-Induced Nephropathy after Intravenous Contrast Medium Injection: A Randomized Controlled Trial. Korean J Radiol. 2020 Nov;21(11):1230-1238. doi: 10.3348/kjr.2019.0916. Epub 2020 Jul 27.

  PMID: 32729273 RESULT

• Koch C, Chaudru S, Lederlin M, Jaquinandi V, Kaladji A, Mahe G. Remote Ischemic Preconditioning and Contrast-Induced Nephropathy: A Systematic Review. Ann Vasc Surg. 2016 Apr;32:176-87. doi: 10.1016/j.avsg.2015.10.017. Epub 2016 Jan 21.

  PMID: 26802296 RESULT

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Guillaume Mahe, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: June 12, 2015
• Study Start: October 6, 2015
• Primary Completion: August 24, 2017
• Study Completion: October 31, 2020
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

FR (1)