Clinical trial NCT02729155: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Reperfusion Injury
Keywords: Ischemic Preconditioning
Postconditioning
Angioplasty
Angiography
Contrast-Induced Nephropathy
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 596
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: 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
timeFrame: Within a period of 24 hours after contrast medium administration
Secondary outcomes:
measure: Change in sCr and eGFR from baseline
timeFrame: Within a period of 24 hours after contrast medium administration
measure: Major adverse cerebrovascular and cardiovascular events (MACCE) in each intervention group
timeFrame: Within a period of 6 months after contrast medium administration
measure: Incidence(%) of CI-AKI in differrent subgroups of patient characteristics
timeFrame: Within a period of 24 hours after contrast medium administration
measure: Incidence(%) of CI-AKI in patients with vs without RIPre and RIPost
timeFrame: Within a period of 24 hours after contrast medium administration
measure: Incidence(%) of MACCE in differrent subgroups of patient characteristics
timeFrame: Within a period of 6 months after contrast medium administration
measure: Incidence(%) of MACCE in patients with vs without RIPre and RIPost
timeFrame: Within a period of 6 months after contrast medium administration
measure: Incidence(%) of MACCE in patients who have CI-AKI vs patients who have no CI-AKI
timeFrame: Within a period of 6 months after contrast medium administration
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Internal Medicine
Study officials:
affiliation: Phramongkutklao College of Medicine and Hospital
name: Nakarin Sansanayudh, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: