Remote Ischemic Preconditioning for Renal Protection in TAVI

Henry Ford Health System46 enrolled

Overview

Severe aortic stenosis remains a major cause of morbidity and mortality of the elderly affecting approximately 3% of elderly patients with an increasing number of patients undergoing transcatheter aortic valve interventions. As part of pre-procedural planning these patients undergo CT scans and receive contrast during the procedure. These patients often have baseline renal insufficiency and are high risk of contrast induced nephropathy despite pre-hydration techniques. The purpose of this study is to evaluate the efficacy of this simple and safe procedure in preventing renal injury in this particular population.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Aortic Valve Stenosis Renal Insufficiency Contrast-induced Nephropathy

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Adults aged 18 or older presenting with moderate to severe aortic stenosis for a trans-catheter aortic valve intervention Exclusion Criteria: * Patients in cardiogenic shock defined as requiring circulatory or hemodynamic support with a device, vasopressors or inotropes * Systemic hypotension (systolic blood pressure \< 90mmHg) * Patients currently on hemodialysis * Presence of an arteriovenous dialysis fistula or graft or lymphedema in either arm * Patients enrolled in other active cardiovascular investigational studies * Severe comorbidities with a life expectancy of less than 6 months * Pregnant or lactating women * Patients unable to provide consent * Patients taking the medication glibenclamide for treatment of diabetes

Outcomes

Primary Outcomes

Renal function as a measured by serum creatinine

Assess the effects on post procedure renal injury. Lab work will be obtained in the form of a basic metabolic panel evaluating the creatinine level. A baseline basic metabolic panel will be obtained prior to scheduled procedure to evaluate baseline renal function and then 48-72 hours post procedure, the optimal time to see the effects of contrast induced nephropathy to evaluate the degree of acute kidney injury. The baseline and post procedure measurements of renal function will be compared between both arms of the study.

Time frame: 48-72 hours

Secondary Outcomes

Clinical Outcomes

The patient's electronic medical record will be reviewed at 6 months post procedure. The investigators will be assessing renal function at 6 months if a creatinine (lab) was ordered by the primary provider for any reason.

Time frame: 6 months