Single-cycle Remote Ischemic Preconditioning and Postconditioning for Prevention of Contrast-Induced Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02729155
• Date of registration: 31/03/2016
• Prospective Registration: No
• Primary sponsor: Phramongkutklao College of Medicine and Hospital
• Public title: Single-cycle Remote Ischemic Preconditioning and Postconditioning for Prevention of Contrast-Induced Nephropathy
• Scientific 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
• Date of first enrolment: October 2015
• Target sample size: 596
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02729155
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Thailand

Contacts

• Name: Nakarin Sansanayudh, MD,PhD
• Affiliation: Phramongkutklao College of Medicine and Hospital

• Name: Nakarin Sansanayudh, MD,PhD

• Name: Nakarin Sansanayudh, MD,PhD

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ischemic Reperfusion Injury

Intervention(s)

Procedure: RIPost

Procedure: RIPre

Procedure: Sham-Post

Procedure: Sham-Pre

Primary Outcome(s)

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(s)

Incidence(%) of MACCE in patients with vs without RIPre and RIPost [Time Frame: Within a period of 6 months after contrast medium administration]

Incidence(%) of CI-AKI in differrent subgroups of patient characteristics [Time Frame: Within a period of 24 hours after contrast medium administration]

Incidence(%) of MACCE in differrent subgroups of patient characteristics [Time Frame: Within a period of 6 months after contrast medium administration]

Incidence(%) of CI-AKI in patients with vs without RIPre and RIPost [Time Frame: Within a period of 24 hours after contrast medium administration]

Change in sCr and eGFR from baseline [Time Frame: Within a period of 24 hours after contrast medium administration]

Major adverse cerebrovascular and cardiovascular events (MACCE) in each intervention group [Time Frame: Within a period of 6 months after contrast medium administration]

Incidence(%) of MACCE in patients who have CI-AKI vs patients who have no CI-AKI [Time Frame: Within a period of 6 months after contrast medium administration]

Secondary ID(s)

PMK-SCRIP-CIN

Source(s) of Monetary Support

Please refer to primary and secondary sponsors