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Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP (NEPHRON Trial)
Phase 4
Waitlist Available
Led By Michel Nguyen, MD, FRCPC
Research Sponsored by Université de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to PCI.
Eligible Conditions
- Kidney Failure
- Nephropathy
- Coronary Heart Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: C: Hydratation with sodium bicarbonateExperimental Treatment1 Intervention
hydratation with sodium bicarbonate (150 mEq/L) at 3 cc/kg/h (max 330 cc/h) for 1 hour before the test and then, to be continued at 1 cc/kg/h (max 110 cc/h) for 6 hours (total of 7 hours of hydratation).
Group II: A: Hydratation according LVEDP + NaHCO3Experimental Treatment1 Intervention
Hydration with bolus of NaCl 0.9 to reach a LVEDP of 18 mmHg or more. This procedure is done while the patient is in the laboratory, with a catheter in the left ventricle.
At the same time, an infusion of a sodium bicarbonate solution (150 mEq/L) is started at a rate of 1 ml/kg/h (max 110 ml/h) for 7 hours.
Group III: B: Standard hydratationActive Control1 Intervention
hydratation with normal saline (1 cc/kg/h; max 110 cc/h) starting at 8PM the day before the test and ending at 8PM the day of the test (24 hours total).
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Who is running the clinical trial?
Université de SherbrookeLead Sponsor
307 Previous Clinical Trials
77,294 Total Patients Enrolled
Michel Nguyen, MD, FRCPCPrincipal InvestigatorSherbrooke University