Clinical trial NCT03761368: Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective PCI
Official title: Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective Percutaneous Coronary Intervention - Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Remote Ischemic Preconditioning
Contrast Induced - Acute Kidney Injury
Keywords: remote ischemic preconditioning
contrast induced-acute kidney injury
neutrophil gelatinase-associated lipocalin
percutaneous coronary intervention
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of Participants With Contrast Induced-Acute Kidney Injury
timeFrame: 48 to 72 hours after contrast exposure
Secondary outcomes:
measure: Number of Participants With Need of Renal Replacement Therapy
timeFrame: up to 7 days after contrast exposure
measure: Number of Participants Who Presented Cardiogenic Shock
timeFrame: up to 7 days after contrast exposure
measure: Death of Any Cause
timeFrame: up to one month after contrast exposure
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Intensive Cardiac Therapy Clinic
Study officials:
affiliation: Medical University of Lodz
name: Marzenna Zielinska, MD PhD
role: STUDY_CHAIR
References:
citation: Stokfisz K, Ledakowicz-Polak A, Kidawa M, Zielinska M. Remote Ischemic Preconditioning and Contrast-Induced Acute Kidney Injury in Patients Undergoing Elective Percutaneous Coronary Intervention: A Randomized Clinical Trial. Curr Ther Res Clin Exp. 2020 Aug 5;93:100599. doi: 10.1016/j.curtheres.2020.100599. eCollection 2020.