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Remote Ischemic Preconditioning as a New Method of Nephroprotection

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
remote ischemic preconditioning
no - 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 Acute Kidney Injury focused on measuring remote ischemic preconditioning, cardiac surgery-associated acute kidney injury, neutrophil gelatinase-associated lipocalin

Eligibility Criteria

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

Inclusion Criteria:

  • Human patients with coronary artery disease.

Exclusion Criteria:

  • history of cardiac surgery,
  • acute myocardial infarction up to 7 days before surgery,
  • chronic kidney disease in 4th or 5th stadium (eGFR<30 ml/min/1,73m2),
  • peripheral vascular disease affecting upper limbs,
  • history of severe injuries and surgeries in 2 months before cardiac surgery,
  • history of cancer, acute inflammation during hospitalization,
  • chronic autoimmunology diseases,
  • dialysis patients.

Sites / Locations

  • Intensive Cardiac Therapy Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Patients with RIPC

Patients without RIPC

Arm Description

intervention: remote ischemic preconditioning - three cycles of 5-min ischemia, achieved by inflation of blood-pressure cuff to 200 mmHg, followed by 5-min reperfusion while the cuff was deflated were applied to the upper left arm.

intervention: no - remote ischemic preconditioning - in controls, the cuff was placed around the arm but not inflated.

Outcomes

Primary Outcome Measures

incidence of acute kidney injury within 72 hours after cardiac surgery
increase in serum creatinine level by more than 50% or more than 0.3mg/dL from baseline within 72 h after surgery
NGAL level
increased NGAL level within 3 hours after cardiac surgery

Secondary Outcome Measures

length of hospitalization
time until discharge from the hospital
length of intensive care unit (ICU) stay
time until discharge from ICU
ventilation time
time of mechanical ventilation
occurrence of postoperative atrial fibrillation
incidence of atrial fibrylation in continous electrocardiogram registration
time of renal replacement therapy
days of renal replacement therapy
death
death from any cause

Full Information

First Posted
June 29, 2017
Last Updated
June 29, 2017
Sponsor
Medical University of Lodz
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1. Study Identification

Unique Protocol Identification Number
NCT03205410
Brief Title
Remote Ischemic Preconditioning as a New Method of Nephroprotection
Official Title
Remote Ischemic Preconditioning as a New Method of Nephroprotection in Patients Undergoing Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
December 31, 2014 (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
Remote ischemic preconditioning (RIPC), elicited by brief episodes of ischemia and reperfusion in distant tissue, offers a protection against acute kidney injury (AKI) in patients after cardiac surgery. Investigators conducted a prospective, randomized, controlled clinical trial to assess whether RIPC reduces the incidence of AKI measured by standard way using serum creatinine concentration (SCr) and with use of serum level of neutrophil gelatinase-associated lipocalin (NGAL) as a new potential biomarker of a kidney injury. Moreover the aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective, isolated, primary off-pump coronary artery bypass graft surgery (OPCAB).
Detailed Description
Cardiac surgery patients have a high risk of AKI. The development of AKI is associated with higher mortality and a higher risk for complications in patients undergoing cardiac surgery. However, there are no effective clinical strategies for preventing prevalence of AKI. RIPC as a simple, inexpensive way of protecting tissues against ischemic damage, may also reduce kidney injury. That makes RIPC under the area of interests of many researches which apply this method to prevent AKI. Investigators conducted a single-center, double-blind trial involving patients at high risk of postoperative AKI, in which want to check wether RIPC reduce the prevalence of AKI, according Kidney Disease: Improving Global Outcomes (KDIGO) definition, by increase in SCr. Furthermore researchers want to investigate a benefit from RIPC in reduction of level of SCr and higher glomerular filtration rate (GFR) 72 hours after off-pump coronary artery bypass as well as reduction of postoperative expression of NGAL an early biomarker of AKI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
remote ischemic preconditioning, cardiac surgery-associated acute kidney injury, neutrophil gelatinase-associated lipocalin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Patients were randomly assigned in 1:1 ratio to either the RIPC group or the control group by means of a computerized randomization table.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with RIPC
Arm Type
Experimental
Arm Description
intervention: remote ischemic preconditioning - three cycles of 5-min ischemia, achieved by inflation of blood-pressure cuff to 200 mmHg, followed by 5-min reperfusion while the cuff was deflated were applied to the upper left arm.
Arm Title
Patients without RIPC
Arm Type
Sham Comparator
Arm Description
intervention: no - remote ischemic preconditioning - in controls, the cuff was placed around the arm but not inflated.
Intervention Type
Procedure
Intervention Name(s)
remote ischemic preconditioning
Other Intervention Name(s)
RIPC
Intervention Description
The remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery.
Intervention Type
Procedure
Intervention Name(s)
no - remote ischemic preconditioning
Other Intervention Name(s)
no-RIPC
Intervention Description
The sham - remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery.
Primary Outcome Measure Information:
Title
incidence of acute kidney injury within 72 hours after cardiac surgery
Description
increase in serum creatinine level by more than 50% or more than 0.3mg/dL from baseline within 72 h after surgery
Time Frame
72 hours after cardiac surgery
Title
NGAL level
Description
increased NGAL level within 3 hours after cardiac surgery
Time Frame
3 hours after cardiac surgery
Secondary Outcome Measure Information:
Title
length of hospitalization
Description
time until discharge from the hospital
Time Frame
through hospitalization completion, an average of 14 days
Title
length of intensive care unit (ICU) stay
Description
time until discharge from ICU
Time Frame
through ICU stay completion, an average of 5 days
Title
ventilation time
Description
time of mechanical ventilation
Time Frame
through ICU stay completion, an average of 5 days
Title
occurrence of postoperative atrial fibrillation
Description
incidence of atrial fibrylation in continous electrocardiogram registration
Time Frame
through ICU stay completion, an average of 5 days
Title
time of renal replacement therapy
Description
days of renal replacement therapy
Time Frame
through ICU stay completion, an average of 5 days
Title
death
Description
death from any cause
Time Frame
from date of randomization until the date of death from any cause, assessed up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Human patients with coronary artery disease. Exclusion Criteria: history of cardiac surgery, acute myocardial infarction up to 7 days before surgery, chronic kidney disease in 4th or 5th stadium (eGFR<30 ml/min/1,73m2), peripheral vascular disease affecting upper limbs, history of severe injuries and surgeries in 2 months before cardiac surgery, history of cancer, acute inflammation during hospitalization, chronic autoimmunology diseases, dialysis patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marzenna Zielinska, MD,PhD,Prof.
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 datasets used and/or analyzed during the current status of the study are available from the corresponding author on reasonable request.
Citations:
PubMed Identifier
32091672
Citation
Stokfisz K, Ledakowicz-Polak A, Zagorski M, Jander S, Przybylak K, Zielinska M. The clinical utility of remote ischemic preconditioning in protecting against cardiac surgery-associated acute kidney injury: A pilot randomized clinical trial. Adv Clin Exp Med. 2020 Feb;29(2):189-196. doi: 10.17219/acem/112610.
Results Reference
derived

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Remote Ischemic Preconditioning as a New Method of Nephroprotection

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