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

Medical University of Lodz

Status: Completed

Conditions: Remote Ischemic Preconditioning; Contrast Induced - Acute Kidney Injury

Treatments: Procedure: Sham Remote Ischemic Preconditioning; Procedure: Remote Ischemic Preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03761368

RNN/219/13/KE

Details and patient eligibility

About

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).

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

101 participants in 2 patient groups

RIPC group

Experimental group

Description:

The RIPC group underwent Remote Ischemic Preconditioning.

Treatment:

Procedure: Remote Ischemic Preconditioning

Control group

Sham Comparator group

Description:

Patients from control group had sham Remote Ischemic Preconditioning.

Treatment:

Procedure: Sham Remote Ischemic Preconditioning