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

NCT ID: NCT03761368

Last Updated: 2020-11-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-01

Study Completion Date

2018-06-30

Brief Summary

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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).

Detailed Description

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Nowadays CI-AKI is defined according to serum creatinine concentration (SCr) as any of the following: (1) an absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or (2) a relative increase of 25% in serum creatinine compared to baseline within 48 to 72 hours after contrast administration. In the last decades, several novel biomarkers of AKI have been studied including neutrophil gelatinase-associated lipocalin (NGAL). Furthermore, remote ischemic preconditioning (RIPC) turned out to be one of the most promising and intriguing non-pharmacological strategy. This simple procedure consisting of brief, non-lethal episodes of ischemia and reperfusion applied in one tissue or organ protects remote tissues or organs from subsequent injury.

Conditions

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Remote Ischemic Preconditioning Contrast Induced - Acute Kidney Injury

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
Blinded investigator, not involved in either CA or randomization procedure, performed assignment intervention.

Study Groups

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RIPC group

The RIPC group underwent Remote Ischemic Preconditioning.

Group Type EXPERIMENTAL

Remote Ischemic Preconditioning

Intervention Type PROCEDURE

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

Control group

Patients from control group had sham Remote Ischemic Preconditioning.

Group Type SHAM_COMPARATOR

Sham Remote Ischemic Preconditioning

Intervention Type PROCEDURE

deflated cuff placed on the left arm for 40 min

Interventions

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Remote Ischemic Preconditioning

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

Intervention Type PROCEDURE

Sham Remote Ischemic Preconditioning

deflated cuff placed on the left arm for 40 min

Intervention Type PROCEDURE

Other Intervention Names

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RIPC Sham RIPC

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lodz

OTHER

Sponsor Role lead

Responsible Party

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Karolina Stokfisz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marzenna Zielinska, MD PhD

Role: STUDY_CHAIR

Medical University of Lodz

Locations

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Intensive Cardiac Therapy Clinic

Lodz, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type DERIVED
PMID: 32874376 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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RNN/219/13/KE

Identifier Type: -

Identifier Source: org_study_id