Skip to main content
OpenTrials
Completed

NCT Number: NCT02329444

The Effect of Remote Ischemic Preconditioning on Elective Percutaneous Coronary Intervention in Diabetic Nephropathy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Contrast Induced Acute Kidney Injury

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ulsan University Hospital

Ulsan, 682-714, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote ischemic preconditioning

Procedure

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.

Sham ischemic preconditioning

Procedure

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 outcomes

  1. Incidence of CI-AKI

    Time frame: 48 hours

    defined as a creatinine rise of ≥ 25% or an increase of > 0.5mg/dl from baseline within 48 hours after contrast exposure

Secondary outcomes

  1. Relative change in NGAL levels from baseline

    Time frame: 24 hours

    Defined as a change in serum NGAL value from baseline

  2. Absolute change in NGAL levels from baseline

    Time frame: 24 hours

    Defined as a change in serum NGAL value from baseline

  3. Relative change in serum creatinine from baseline

    Time frame: 72 hours

    Defined as a change in serum value from baseline

Other outcomes

  1. Periprocedural myocardial infarction

    Time frame: 24 hours

    Defined as Trop T or CKMB levels >3 times the upper limit of normal

Sponsors and collaborators

Lead sponsor

Ulsan University Hospital

Other

Registry information

Official study title

Remote Ischemic Preconditioning for the Prevention of Contrast-induced Acute Kidney Injury in Diabetic Patients Undergoing Percutaneous Coronary Intervention

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 31, 2014
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.