N/A
N=101
Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective PCI
Remote Ischemic Preconditioning · Contrast Induced - Acute Kidney Injury
Bottom Line
View on ClinicalTrials.gov: NCT03761368 ↗Enrolled (actual)
101
Serious AEs
2.0%
Results posted
Oct 2020
Primary outcome: Primary: Number of Participants With Contrast Induced-Acute Kidney Injury — 2; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Remote Ischemic Preconditioning (Procedure); Sham Remote Ischemic Preconditioning (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of Lodz
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Contrast Induced-Acute Kidney Injury |
2; 3 | — |
| SECONDARY Number of Participants With Need of Renal Replacement Therapy |
0; 0 | — |
| SECONDARY Number of Participants Who Presented Cardiogenic Shock |
1; 1 | — |
| SECONDARY Death of Any Cause |
0; 0 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT03761368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.