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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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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

Frequently Asked Questions

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~6 spots leftby Apr 2025