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

Primary Purpose

Remote Ischemic Preconditioning, Contrast Induced - Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Remote Ischemic Preconditioning
Sham Remote Ischemic Preconditioning
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Remote Ischemic Preconditioning focused on measuring remote ischemic preconditioning, contrast induced-acute kidney injury, neutrophil gelatinase-associated lipocalin, percutaneous coronary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Intensive Cardiac Therapy Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

RIPC group

Control group

Arm Description

The RIPC group underwent Remote Ischemic Preconditioning.

Patients from control group had sham Remote Ischemic Preconditioning.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Number of Participants Who Presented Cardiogenic Shock
sustained hypotension (systolic blood pressure < 90 mm Hg for ≥30 min)
Death of Any Cause
Number of patients who died.

Full Information

First Posted
November 29, 2018
Last Updated
November 2, 2020
Sponsor
Medical University of Lodz
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1. Study Identification

Unique Protocol Identification Number
NCT03761368
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lodz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Remote Ischemic Preconditioning, Contrast Induced - Acute Kidney Injury
Keywords
remote ischemic preconditioning, contrast induced-acute kidney injury, neutrophil gelatinase-associated lipocalin, percutaneous coronary intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Masking Description
Blinded investigator, not involved in either CA or randomization procedure, performed assignment intervention.
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIPC group
Arm Type
Experimental
Arm Description
The RIPC group underwent Remote Ischemic Preconditioning.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Patients from control group had sham Remote Ischemic Preconditioning.
Intervention Type
Procedure
Intervention Name(s)
Remote Ischemic Preconditioning
Other Intervention Name(s)
RIPC
Intervention Description
four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff
Intervention Type
Procedure
Intervention Name(s)
Sham Remote Ischemic Preconditioning
Other Intervention Name(s)
Sham RIPC
Intervention Description
deflated cuff placed on the left arm for 40 min
Primary Outcome Measure Information:
Title
Number of Participants With Contrast Induced-Acute Kidney Injury
Description
absolute rise of ≥ 0.5 mg/dL (44 µmol/L) and/or a relative increase of 25% in serum creatinine compared to baseline
Time Frame
48 to 72 hours after contrast exposure
Secondary Outcome Measure Information:
Title
Number of Participants With Need of Renal Replacement Therapy
Description
qualification for RRT according to standard clinical criteria (level of serum creatinine, serum urea concentration, electrolytes levels (sodium, potassium, chlorides), hydration management)
Time Frame
up to 7 days after contrast exposure
Title
Number of Participants Who Presented Cardiogenic Shock
Description
sustained hypotension (systolic blood pressure < 90 mm Hg for ≥30 min)
Time Frame
up to 7 days after contrast exposure
Title
Death of Any Cause
Description
Number of patients who died.
Time Frame
up to one month after contrast exposure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marzenna Zielinska, MD PhD
Organizational Affiliation
Medical University of Lodz
Official's Role
Study Chair
Facility Information:
Facility Name
Intensive Cardiac Therapy Clinic
City
Lodz
ZIP/Postal Code
92-213
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
32874376
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.
Results Reference
derived

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

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