The Effect of Remote Ischemic Preconditioning on Elective Percutaneous Coronary Intervention in Diabetic Nephropathy
Primary Purpose
Contrast Induced Acute Kidney Injury
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remote ischemic preconditioning
Sham ischemic preconditioning
Sponsored by
About this trial
This is an interventional treatment trial for Contrast Induced Acute Kidney Injury
Eligibility Criteria
Inclusion Criteria:
- Informed written consent
- All of the following:
- Known diagnosis of Type 2 diabetes
- NSTEMI, unstable or stable angina
- Patients undergoing elective coronary angiography and/or percutaneous coronary intervention
- eGFR < 60 mls/min or ACR > 300 mg/dl
Exclusion Criteria:
- STEMI
- decompensated heart failure in the preceding 6 months
- patients with underlying end stage renal disease on maintenance dialysis
- recent (in the last 3 months) cerebrovascular disease
- chronic liver disease
- chronic obstructive pulmonary disease
- gastrointestinal bleeding
- acute or chronic infection or malignancy
Sites / Locations
- Ulsan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Remote Ischemic Preconditioning
Sham ischemic preconditioning
Arm Description
Patients treated with Remote Ischemic Preconditioning
Patients treated with sham ischemic preconditioning
Outcomes
Primary Outcome Measures
Incidence of CI-AKI
defined as a creatinine rise of ≥ 25% or an increase of > 0.5mg/dl from baseline within 48 hours after contrast exposure
Secondary Outcome Measures
Relative change in NGAL levels from baseline
Defined as a change in serum NGAL value from baseline
Absolute change in NGAL levels from baseline
Defined as a change in serum NGAL value from baseline
Relative change in serum creatinine from baseline
Defined as a change in serum value from baseline
Full Information
NCT ID
NCT02329444
First Posted
December 29, 2014
Last Updated
April 2, 2019
Sponsor
Ulsan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02329444
Brief Title
The Effect of Remote Ischemic Preconditioning on Elective Percutaneous Coronary Intervention in Diabetic Nephropathy
Official Title
Remote Ischemic Preconditioning for the Prevention of Contrast-induced Acute Kidney Injury in Diabetic Patients Undergoing Percutaneous Coronary Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ulsan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of contrast media use associated with prolonged hospitalization, cardiovascular events, persistent kidney damage and increased risk of all-cause mortality. When remote ischemic preconditioning is applied before percutaneous coronary intervention (PCI), the kidneys can be protected against ischemia-reperfusion injury and subsequently CI-AKI. In this randomised controlled trial, diabetic nephropathy patients undergoing PCI as part of their assessment and treatment of cardiovascular disease are randomized to receive RIPC or control sham preconditioning.
Detailed Description
Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of contrast media use associated with prolonged hospitalization, cardiovascular events, persistent kidney damage and increased risk of all-cause mortality. Diabetes with pre-existing renal disease can increase the risk of CI-AKI. Remote ischemic preconditioning (RIPC) is a non-pharmacological strategy inducing transient episodes of ischemia by the occlusion of blood flow in non-target tissue such as a limb, before a subsequent prolonged ischemia-reperfusion injury occurs in a more distant organ. These brief, repeated ischemic episodes in the limb can confer a protection at more remote sites such as the heart, brain, lung, kidney, intestine or skeletal muscle. In a recent pilot study, using RIPC prior to coronary angiography in high risk patients with moderate chronic kidney disease, the authors found that RIPC significantly reduced the incidence of CI-AKI (Er et al Circulation. 2012;126(3),296). We hypothesized that RIPC would be protective as an adjunctive therapy in reducing the incidence of CI-AKI in diabetics with pre-existing CKD. This prospective study was performed to evaluate the efficacy of RIPC for the prevention of CI-AKI among diabetic nephropathy patients undergoing percutaneous coronary intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Acute Kidney Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remote Ischemic Preconditioning
Arm Type
Experimental
Arm Description
Patients treated with Remote Ischemic Preconditioning
Arm Title
Sham ischemic preconditioning
Arm Type
Active Comparator
Arm Description
Patients treated with sham ischemic preconditioning
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic preconditioning
Intervention Description
Appropriately sized sphygmomanometer cuff placed around right upper arm; where contraindicated, left arm, with inflation of the cuff up to 200mmHg for 5 minutes, followed by deflation of 5 minutes to allow reperfusion with cycle repeated 3 times.
Intervention Type
Procedure
Intervention Name(s)
Sham ischemic preconditioning
Intervention Description
Appropriately sized sphygmomanometer cuff placed around right upper arm; where contraindicated, left arm, with inflation of the cuff up to 50mmHg for 5 minutes, followed by deflation of 5 minutes to allow reperfusion with cycle repeated 3 times.
Primary Outcome Measure Information:
Title
Incidence of CI-AKI
Description
defined as a creatinine rise of ≥ 25% or an increase of > 0.5mg/dl from baseline within 48 hours after contrast exposure
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Relative change in NGAL levels from baseline
Description
Defined as a change in serum NGAL value from baseline
Time Frame
24 hours
Title
Absolute change in NGAL levels from baseline
Description
Defined as a change in serum NGAL value from baseline
Time Frame
24 hours
Title
Relative change in serum creatinine from baseline
Description
Defined as a change in serum value from baseline
Time Frame
72 hours
Other Pre-specified Outcome Measures:
Title
Periprocedural myocardial infarction
Description
Defined as Trop T or CKMB levels >3 times the upper limit of normal
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed written consent
All of the following:
Known diagnosis of Type 2 diabetes
NSTEMI, unstable or stable angina
Patients undergoing elective coronary angiography and/or percutaneous coronary intervention
eGFR < 60 mls/min or ACR > 300 mg/dl
Exclusion Criteria:
STEMI
decompensated heart failure in the preceding 6 months
patients with underlying end stage renal disease on maintenance dialysis
recent (in the last 3 months) cerebrovascular disease
chronic liver disease
chronic obstructive pulmonary disease
gastrointestinal bleeding
acute or chronic infection or malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eun-Seok Shin, MD., PhD.
Organizational Affiliation
Ulsan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
682-714
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
27723839
Citation
Balbir Singh G, Ann SH, Park J, Chung HC, Lee JS, Kim ES, Choi JI, Lee J, Kim SJ, Shin ES. Remote Ischemic Preconditioning for the Prevention of Contrast-Induced Acute Kidney Injury in Diabetics Receiving Elective Percutaneous Coronary Intervention. PLoS One. 2016 Oct 10;11(10):e0164256. doi: 10.1371/journal.pone.0164256. eCollection 2016.
Results Reference
derived
Learn more about this trial
The Effect of Remote Ischemic Preconditioning on Elective Percutaneous Coronary Intervention in Diabetic Nephropathy
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