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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).

Find a Location

Who is running the clinical trial?

Université de SherbrookeLead Sponsor
292 Previous Clinical Trials
69,111 Total Patients Enrolled
1 Trials studying Kidney Failure
43 Patients Enrolled for Kidney Failure
Michel Nguyen, MD, FRCPCPrincipal InvestigatorSherbrooke University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP
Michel Nguyen 2007. "Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00584350.
All > Prevention
~19 spots leftby Apr 2025
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