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

Ischemic Reperfusion Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02729155
• Other study ID #: PMK-SCRIP-CIN
• Status: Recruiting
• Phase: N/A
• Start date: October 2015
• Est. completion date: May 2020

Study information

• Verified date: August 2018
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: Nakarin Sansanayudh, MD,PhD
• Phone: +6627639300
• Email: dr_nakarin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

randomized controlled trial

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 596
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Reperfusion Injury
• Reperfusion Injury

Intervention

Procedure:
• RIPre
Preconditioning 200 mmHg x 5 minutes before procedure
• RIPost
Postconditioning 200 mmHg x 5 minutes after procedure
• Sham-Pre
Sham 10 mmHg x 5 minutes before procedure
• Sham-Post
Sham 10 mmHg x 5 minutes after procedure

Locations

Country	Name	City	State
Thailand	Department of Internal Medicine	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Phramongkutklao College of Medicine and Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Change in sCr and eGFR from baseline		Within a period of 24 hours after contrast medium administration
Secondary	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	Within a period of 6 months after contrast medium administration
Secondary	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.	Within a period of 24 hours after contrast medium administration
Secondary	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	Within a period of 24 hours after contrast medium administration
Secondary	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	Within a period of 6 months after contrast medium administration
Secondary	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	Within a period of 6 months after contrast medium administration
Secondary	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	Within a period of 6 months after contrast medium administration