Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective PCI

NCT03761368 | Completed Results

• 1 other identifier: RNN/219/13/KE
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, randomized, sham-controlled clinical study was conducted to assess whether RIPC reduces the incidence of CI-AKI measured standard way of using SCr concentration but also with the use of serum NGAL as a new potential biomarker of kidney injury. Furthermore, the aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective coronary angiography (CA) followed by percutaneous coronary intervention (PCI).

Conditions

Remote Ischemic Preconditioning; Contrast Induced - Acute Kidney Injury

Keywords

remote ischemic preconditioning; contrast induced-acute kidney injury; neutrophil gelatinase-associated lipocalin; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Contrast Induced-Acute Kidney Injury

  absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or a relative increase of 25% in serum creatinine compared to baseline

  48 to 72 hours after contrast exposure

Secondary Outcomes (3)

• Number of Participants With Need of Renal Replacement Therapy

  up to 7 days after contrast exposure

• Number of Participants Who Presented Cardiogenic Shock

  up to 7 days after contrast exposure

• Death of Any Cause

  up to one month after contrast exposure

Study Arms (2)

RIPC group

EXPERIMENTAL

The RIPC group underwent Remote Ischemic Preconditioning.

Procedure: Remote Ischemic Preconditioning

Control group

SHAM COMPARATOR

Patients from control group had sham Remote Ischemic Preconditioning.

Procedure: Sham Remote Ischemic Preconditioning

Interventions

Remote Ischemic Preconditioning PROCEDURE

four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff

Also known as: RIPC

RIPC group

Sham Remote Ischemic Preconditioning PROCEDURE

deflated cuff placed on the left arm for 40 min

Also known as: Sham RIPC

Control group

Eligibility Criteria

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

You may qualify if:

• aged over 18 years
• patients with stable angina pectoris
• patients admitted to Intensive Cardiac Therapy Clinic Medical University of Lodz with intention of elective CA with follow-up PCI.

You may not qualify if:

• history of severe injuries up to 2 months before intervention
• history of surgeries up to 2 months before intervention
• history of cancer,
• acute inflammation during hospitalization
• chronic autoimmunologic diseases
• patients needing hemodialysis
• chronic kidney disease in stage 4 or 5 (eGFR\<30 ml/min/1,73m2)
• peripheral vascular disease affecting upper limbs.

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Intensive Cardiac Therapy Clinic

Lodz, 92-213, Poland

Location

Related Publications (1)

• Stokfisz K, Ledakowicz-Polak A, Kidawa M, Zielinska M. Remote Ischemic Preconditioning and Contrast-Induced Acute Kidney Injury in Patients Undergoing Elective Percutaneous Coronary Intervention: A Randomized Clinical Trial. Curr Ther Res Clin Exp. 2020 Aug 5;93:100599. doi: 10.1016/j.curtheres.2020.100599. eCollection 2020.

  PMID: 32874376 DERIVED

Limitations and Caveats

1. Single-center trial. 2. Relatively small sample size. 3. We were unable to observe sufficient number of events, such as CI-AKI, mortality, need for dialysis as an endpoint.

Results Point of Contact

• Title: Karolina Stokfisz
• Organization: Medical University of Łódź

stokfisz.karolina@gmail.com

+48422014260

Study Officials

• Marzenna Zielinska, MD PhD

  Medical University of Lodz

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Blinded investigator, not involved in either CA or randomization procedure, performed assignment intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: After admission to the Department, patients were randomly assigned in 1:1 ratio to either control group or RIPC - group by means of a computerized randomization table.

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 3, 2018
• Study Start: March 1, 2015
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: November 19, 2020
• Results First Posted: October 30, 2020

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 years after the end of the study
• Access Criteria: on reasonable request

Locations

PL (1)