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

Not Applicable

Completed

• Conditions: Remote Ischemic Preconditioning; Contrast Induced - Acute Kidney Injury
• Interventions: Procedure: Sham Remote Ischemic Preconditioning; Procedure: Remote Ischemic Preconditioning

• Registration Number: NCT03761368
• Lead Sponsor: Medical University of Lodz

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).

Detailed Description

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 Timeline

• Study Start: 2015-03-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2018-11
• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-11-30
• Study First Posted: 2018-12-03
• Results First Submitted: 2020-06-12
• Results First Submitted QC: 2020-10-08
• Results First Posted: 2020-10-30
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Sham Remote Ischemic Preconditioning	Patients from control group had sham Remote Ischemic Preconditioning.
RIPC group	Remote Ischemic Preconditioning	The RIPC group underwent Remote Ischemic Preconditioning.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Contrast Induced-Acute Kidney Injury	48 to 72 hours after contrast exposure	absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or a relative increase of 25% in serum creatinine compared to baseline

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Need of Renal Replacement Therapy	up to 7 days after contrast exposure	qualification for RRT according to standard clinical criteria (level of serum creatinine, serum urea concentration, electrolytes levels (sodium, potassium, chlorides), hydration management)
Number of Participants Who Presented Cardiogenic Shock	up to 7 days after contrast exposure	sustained hypotension (systolic blood pressure \< 90 mm Hg for ≥30 min)
Death of Any Cause	up to one month after contrast exposure	Number of patients who died.

Trial Locations

Locations (1)

Intensive Cardiac Therapy Clinic; 🇵🇱 Lodz, Poland