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

Study Overview
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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.

Official Title
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Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective Percutaneous Coronary Intervention - Randomised Clinical Trial

Conditions
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Remote Ischemic Preconditioning, Contrast Induced - Acute Kidney Injury

Intervention / Treatment
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* Procedure: Remote Ischemic Preconditioning
* Procedure: Sham Remote Ischemic Preconditioning


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIPC group<br>The RIPC group underwent Remote Ischemic Preconditioning. | Procedure: Remote Ischemic Preconditioning<br>* four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff<br>* Other names: RIPC;|
| Sham Comparator: Control group<br>Patients from control group had sham Remote Ischemic Preconditioning. | Procedure: Sham Remote Ischemic Preconditioning<br>* deflated cuff placed on the left arm for 40 min<br>* Other names: Sham RIPC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | up to 7 days after contrast exposure | 
| Death of Any Cause | Number of patients who died. | up to one month after contrast exposure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remote ischemic preconditioning, contrast induced-acute kidney injury, neutrophil gelatinase-associated lipocalin, percutaneous coronary intervention