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

Contrast Induced Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329444
• Other study ID #: 2011-08-074
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2019
• Source: Ulsan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Contrast Induced Acute Kidney Injury

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Periprocedural myocardial infarction	Defined as Trop T or CKMB levels >3 times the upper limit of normal	24 hours
Primary	Incidence of CI-AKI	defined as a creatinine rise of = 25% or an increase of > 0.5mg/dl from baseline within 48 hours after contrast exposure	48 hours
Secondary	Relative change in NGAL levels from baseline	Defined as a change in serum NGAL value from baseline	24 hours
Secondary	Absolute change in NGAL levels from baseline	Defined as a change in serum NGAL value from baseline	24 hours
Secondary	Relative change in serum creatinine from baseline	Defined as a change in serum value from baseline	72 hours