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

Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective Percutaneous Coronary Intervention - Randomised Clinical Trial

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).

Study Overview

• Status: Completed
• Conditions: Remote Ischemic Preconditioning; Contrast Induced - Acute Kidney Injury
• Intervention / Treatment: Procedure: Remote Ischemic Preconditioning; Procedure: Sham Remote Ischemic Preconditioning

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Lodz, Poland, 92-213
    • Intensive Cardiac Therapy Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIPC group; The RIPC group underwent Remote Ischemic Preconditioning.	Procedure: Remote Ischemic Preconditioning; four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff; Other Names: RIPC
Sham Comparator: Control group; Patients from control group had sham Remote Ischemic Preconditioning.	Procedure: Sham Remote Ischemic Preconditioning; deflated cuff placed on the left arm for 40 min; Other Names: Sham RIPC

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Lodz
• Investigators: Study Chair: Marzenna Zielinska, MD PhD, Medical University of Lodz

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; remote ischemic preconditioning; neutrophil gelatinase-associated lipocalin; contrast induced-acute kidney injury
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Ischemia; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: RNN/219/13/KE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: 3 years after the end of the study
• IPD Sharing Access Criteria: on reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No