Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective Percutaneous Coronary Intervention - Randomised Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Remote Ischemic Preconditioning
- Sponsor
- Medical University of Lodz
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Number of Participants With Contrast Induced-Acute Kidney Injury
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Karolina Stokfisz
Principal Investigator
Medical University of Lodz
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Number of Participants With Contrast Induced-Acute Kidney Injury
Time Frame: 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 Outcomes
- 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)