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Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP (NEPHRON)

This study is currently recruiting participants.
Verified June 2012 by Universitaire de Sherbrooke
Sponsor:
Information provided by (Responsible Party):
Michel Nguyen, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00584350
First received: December 20, 2007
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Radiographic Contrast Agent Nephropathy
Renal Failure
Coronary Heart Disease
 Drug: Normal saline and sodium bicarbonate
Drug: normal saline
Drug: Sodium bicarbonate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitaire de Sherbrooke:

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. [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • changes in glomerular filtration in the 3 groups (measured with MDRD formula) [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • clinical events during the procedure or after (ex. pulmonary edema) [ Time Frame: during hospitalisation ] [ Designated as safety issue: Yes ]
  • Incidence of contrast nephropathy defined as an increase of 25% of the creatinine value at 48 hours [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 330
Study Start Date: November 2007
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A

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.

 Drug: Normal saline and sodium bicarbonate

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.
Active Comparator: B
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).
 Drug: normal saline
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).
Experimental: C
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).
 Drug: Sodium bicarbonate
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • minimum 18 years old
  • chronic renal insufficiency with a calculated creatinine clearance below 60 cc /min. (estimated with the MDRD formula)
  • hemodynamically stable

Exclusion Criteria:

  • Acute renal failure or in recuperation of acute renal failure
  • urgent coronary angiogram
  • moderate to severe valvulopathy or presence of a valvular prosthesis
  • diagnostic of multiple myeloma
  • dialysis before test
  • having had a test with contrast product in the 2 weeks preceding
  • receiving a nephrotoxic in the last month.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584350

Contacts
Contact: Michel Nguyen, MD, FRCPC 819 346-1110 ext 15251 michel.nguyen@usherbrooke.ca

Locations
Canada, Quebec
CHUS, clinical research center Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Principal Investigator: Michel Nguyen, MD, FRCPC            
Sponsors and Collaborators
Universitaire de Sherbrooke
Investigators
Principal Investigator: Michel Nguyen, MD, FRCPC Sherbrooke University
  More Information

No publications provided

Responsible Party: Michel Nguyen, Doctor, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT00584350     History of Changes
Other Study ID Numbers: 03-70-M5
Study First Received: December 20, 2007
Last Updated: June 12, 2012
Health Authority: Canada: Health Canada

Keywords provided by Universitaire de Sherbrooke:
coronary angiogram
percutaneous coronary intervention

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Kidney Diseases
Renal Insufficiency
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013