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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by Michel Nguyen, Université de Sherbrooke.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584350
First Posted: January 2, 2008
Last Update Posted: February 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michel Nguyen, Université de Sherbrooke
  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 Other: Hydratation according LVEDP + NaHCO3 Other: normal saline Other: Sodium bicarbonate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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:


Further study details as provided by Michel Nguyen, Université 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 ]

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

Estimated Enrollment: 330
Study Start Date: November 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Hydratation according LVEDP + NaHCO3

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.

Other: Hydratation according LVEDP + NaHCO3

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: Standard hydratation
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).
Other: 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
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).
Other: 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).

Detailed Description:
The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation, independant of volemic status, with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to PCI.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Université de Sherbrooke
Investigators
Principal Investigator: Michel Nguyen, MD, FRCPC Sherbrooke University
  More Information

Responsible Party: Michel Nguyen, Doctor, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT00584350     History of Changes
Other Study ID Numbers: 03-70-M5
First Submitted: December 20, 2007
First Posted: January 2, 2008
Last Update Posted: February 12, 2015
Last Verified: February 2015

Keywords provided by Michel Nguyen, Université de Sherbrooke:
coronary angiogram
percutaneous coronary intervention

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