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A: Hydratation according LVEDP + NaHCO3 for Kidney Failure (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 during hospitalisation
Awards & highlights

NEPHRON 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
  • Nephropathy
  • Kidney Failure
  • Coronary Heart Disease

NEPHRON Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of contrast nephropathy described as an increase of 44 micromol/L in plasma creatinine 48 hours after the injection of contrast product.
Secondary outcome measures
Incidence of contrast nephropathy defined as an increase of 25% of the creatinine value at 48 hours
changes in glomerular filtration in the 3 groups (measured with MDRD formula)
clinical events during the procedure or after (ex. pulmonary edema)

NEPHRON 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
298 Previous Clinical Trials
69,604 Total Patients Enrolled
1 Trials studying Kidney Failure
43 Patients Enrolled for Kidney Failure
Michel Nguyen, MD, FRCPCPrincipal InvestigatorSherbrooke University
~19 spots leftby Jun 2025
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