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Intervention for Kidney Failure
N/A
Waitlist Available
Led By William O'Neill, MD
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Adults aged 18 or older presenting with moderate to severe aortic stenosis for a trans-catheter aortic valve intervention
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study 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.
Eligible Conditions
- Kidney Failure
- Aortic Valve Stenosis
- Contrast-induced Nephropathy
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Renal function as a measured by serum creatinine
Secondary outcome measures
Clinical Outcomes
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
This group will undergo remote ischemic preconditioning with serial inflations of the blood pressure cuff to 200 mmHg followed by deflation for reperfusion for a period of 5 minutes each for a total of 4 cycles.
Group II: ControlPlacebo Group1 Intervention
This group will undergo serial inflations of the blood pressure cuff to 40 mmHg followed by deflation for a period of 5 minutes each for a total of 4 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remote ischemic preconditioning
2014
Completed Phase 4
~3410
Find a Location
Who is running the clinical trial?
Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,099,953 Total Patients Enrolled
William O'Neill, MDPrincipal InvestigatorHenry Ford Health System
6 Previous Clinical Trials
12,816 Total Patients Enrolled
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