Aortic Valve Stenosis, Contrast-induced Nephropathy, Renal Insufficiency
Conditions
Brief summary
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.
Interventions
PROCEDURERemote ischemic preconditioning
Serial inflations and deflations as detailed in the arm/group descriptions
PROCEDUREControl
Serial inflations and deflations as detailed in the arm/group descriptions
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal function as a measured by serum creatinine | 48-72 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcomes | 6 months | 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. |
Countries
United States
Outcome results
None listed