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

NCT ID: NCT02329444

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Contrast Induced Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Remote Ischemic Preconditioning

Patients treated with Remote Ischemic Preconditioning

Group Type: EXPERIMENTAL

Remote ischemic preconditioning

Intervention Type: 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

Patients treated with sham ischemic preconditioning

Group Type: ACTIVE_COMPARATOR

Sham ischemic preconditioning

Intervention Type: 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.

Interventions

Remote ischemic preconditioning

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.

Intervention Type: PROCEDURE

Sham ischemic preconditioning

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ulsan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Prof Eun-Seok Shin, MD. PhD.

Interventional Cardiologist MD. PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eun-Seok Shin, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Ulsan University Hospital

Locations

Ulsan University Hospital

Ulsan, , South Korea

Countries

South Korea

References

Balbir Singh G, Ann SH, Park J, Chung HC, Lee JS, Kim ES, Choi JI, Lee J, Kim SJ, Shin ES. Remote Ischemic Preconditioning for the Prevention of Contrast-Induced Acute Kidney Injury in Diabetics Receiving Elective Percutaneous Coronary Intervention. PLoS One. 2016 Oct 10;11(10):e0164256. doi: 10.1371/journal.pone.0164256. eCollection 2016.

Reference Type: DERIVED

PMID: 27723839 (View on PubMed)

Other Identifiers

2011-08-074

Identifier Type: -

Identifier Source: org_study_id