Back to resultsSingle-cycle Remote Ischemic Preconditioning and Postconditioning for Prevention of Contrast-Induced Nephropathy
Primary Purpose
Ischemic Reperfusion Injury
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
RIPre
RIPost
Sham-Pre
Sham-Post
Sponsored by
About this trial
This is an interventional prevention trial for Ischemic Reperfusion Injury focused on measuring Ischemic Preconditioning, Postconditioning, Angioplasty, Angiography, Contrast-Induced Nephropathy
Eligibility Criteria
Inclusion Criteria:
- The patient have indication for coronary angiography or angioplasty.
- Impaired renal function with reduced eGFR < 60 ml/min/1.73 m2 by CKD-EPI equation.
- Written informed consent.
Exclusion Criteria:
- History of contrast allergy.
- The patient had end-stage renal failure with the need for hemodialysis.
- The patient take medications that affect the kidneys function within 48 hours before study.
- The patient had acute kidney injury from any cause.
- The patient was received contrast media within 2 weeks before study.
- The patient had cardiac arrest or shock.
- The patient had peripheral arterial disease (PAD)
- Pregnancy
- Refused to study
Sites / Locations
- Department of Internal MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Sham Comparator
Arm Label
RIPre + RIPost
RIPre + Sham
Sham + RIPost
Sham + Sham
Arm Description
Intervention: RIPre 200 mmHg + RIPost 200 mmHg
Intervention: RIPre 200 mmHg + Sham 10 mmHg
Intervention: Sham 10 mmHg + RIPost 200 mmHg
Intervention: Sham 10 mmHg + Sham 10 mmHg
Outcomes
Primary Outcome Measures
Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value
Secondary Outcome Measures
Change in sCr and eGFR from baseline
Major adverse cerebrovascular and cardiovascular events (MACCE) in each intervention group
MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack
Incidence(%) of CI-AKI in differrent subgroups of patient characteristics
Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM.
Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value.
Incidence(%) of CI-AKI in patients with vs without RIPre and RIPost
Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value
Incidence(%) of MACCE in differrent subgroups of patient characteristics
Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM.
MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack
Incidence(%) of MACCE in patients with vs without RIPre and RIPost
Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM.
MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack
Incidence(%) of MACCE in patients who have CI-AKI vs patients who have no CI-AKI
Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value within a period of 24 hours after contrast medium administration
Full Information
NCT ID
NCT02729155
First Posted
March 31, 2016
Last Updated
August 28, 2018
Sponsor
Phramongkutklao College of Medicine and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02729155
Brief Title
Single-cycle Remote Ischemic Preconditioning and Postconditioning for Prevention of Contrast-Induced Nephropathy
Official Title
Efficacy of Single-cycle Remote Ischemic Pre/Post-conditioning, for Prevention of Contrast-induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Coronary Angiography or Coronary Angioplasty
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Phramongkutklao College of Medicine and Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning for prevention of contrast-induced acute kidney injury in patient undergoing coronary angiography and angioplasty
Detailed Description
randomized controlled trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Reperfusion Injury
Keywords
Ischemic Preconditioning, Postconditioning, Angioplasty, Angiography, Contrast-Induced Nephropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
596 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RIPre + RIPost
Arm Type
Experimental
Arm Description
Intervention: RIPre 200 mmHg + RIPost 200 mmHg
Arm Title
RIPre + Sham
Arm Type
Experimental
Arm Description
Intervention: RIPre 200 mmHg + Sham 10 mmHg
Arm Title
Sham + RIPost
Arm Type
Experimental
Arm Description
Intervention: Sham 10 mmHg + RIPost 200 mmHg
Arm Title
Sham + Sham
Arm Type
Sham Comparator
Arm Description
Intervention: Sham 10 mmHg + Sham 10 mmHg
Intervention Type
Procedure
Intervention Name(s)
RIPre
Intervention Description
Preconditioning 200 mmHg x 5 minutes before procedure
Intervention Type
Procedure
Intervention Name(s)
RIPost
Intervention Description
Postconditioning 200 mmHg x 5 minutes after procedure
Intervention Type
Procedure
Intervention Name(s)
Sham-Pre
Intervention Description
Sham 10 mmHg x 5 minutes before procedure
Intervention Type
Procedure
Intervention Name(s)
Sham-Post
Intervention Description
Sham 10 mmHg x 5 minutes after procedure
Primary Outcome Measure Information:
Title
Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value
Time Frame
Within a period of 24 hours after contrast medium administration
Secondary Outcome Measure Information:
Title
Change in sCr and eGFR from baseline
Time Frame
Within a period of 24 hours after contrast medium administration
Title
Major adverse cerebrovascular and cardiovascular events (MACCE) in each intervention group
Description
MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack
Time Frame
Within a period of 6 months after contrast medium administration
Title
Incidence(%) of CI-AKI in differrent subgroups of patient characteristics
Description
Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM.
Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value.
Time Frame
Within a period of 24 hours after contrast medium administration
Title
Incidence(%) of CI-AKI in patients with vs without RIPre and RIPost
Description
Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value
Time Frame
Within a period of 24 hours after contrast medium administration
Title
Incidence(%) of MACCE in differrent subgroups of patient characteristics
Description
Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM.
MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack
Time Frame
Within a period of 6 months after contrast medium administration
Title
Incidence(%) of MACCE in patients with vs without RIPre and RIPost
Description
Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM.
MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack
Time Frame
Within a period of 6 months after contrast medium administration
Title
Incidence(%) of MACCE in patients who have CI-AKI vs patients who have no CI-AKI
Description
Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value within a period of 24 hours after contrast medium administration
Time Frame
Within a period of 6 months after contrast medium administration
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient have indication for coronary angiography or angioplasty.
Impaired renal function with reduced eGFR < 60 ml/min/1.73 m2 by CKD-EPI equation.
Written informed consent.
Exclusion Criteria:
History of contrast allergy.
The patient had end-stage renal failure with the need for hemodialysis.
The patient take medications that affect the kidneys function within 48 hours before study.
The patient had acute kidney injury from any cause.
The patient was received contrast media within 2 weeks before study.
The patient had cardiac arrest or shock.
The patient had peripheral arterial disease (PAD)
Pregnancy
Refused to study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nakarin Sansanayudh, MD,PhD
Phone
+6627639300
Ext
93807
Email
dr_nakarin@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pawit Pipatwattanakul, MD
Phone
+6613728821
Email
pa_wit@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nakarin Sansanayudh, MD,PhD
Organizational Affiliation
Phramongkutklao College of Medicine and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nakarin Sansanayudh, MD,PhD
Phone
+6623547600
Ext
93827
Email
dr_nakarin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Pawit Pipatwattanakul, MD
Phone
+6613728821
Email
pa_wit@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Single-cycle Remote Ischemic Preconditioning and Postconditioning for Prevention of Contrast-Induced Nephropathy
We'll reach out to this number within 24 hrs