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

Medical University of Lodz101 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

101

Conditions

Remote Ischemic Preconditioning Contrast Induced - Acute Kidney Injury

Interventions

Remote Ischemic PreconditioningPROCEDURE

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

Sham Remote Ischemic PreconditioningPROCEDURE

deflated cuff placed on the left arm for 40 min

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Intensive Cardiac Therapy Clinic

Lodz, Poland

Outcomes

Primary Outcomes

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

Time frame: 48 to 72 hours after contrast exposure

Secondary Outcomes

Number of Participants With Need of Renal Replacement Therapy

qualification for RRT according to standard clinical criteria (level of serum creatinine, serum urea concentration, electrolytes levels (sodium, potassium, chlorides), hydration management)

Time frame: up to 7 days after contrast exposure

Number of Participants Who Presented Cardiogenic Shock

sustained hypotension (systolic blood pressure \< 90 mm Hg for ≥30 min)

Time frame: up to 7 days after contrast exposure

Death of Any Cause

Number of patients who died.

Time frame: up to one month after contrast exposure

Data from ClinicalTrials.gov

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