Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP
NCT ID: NCT00584350
Last Updated: 2015-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
330 participants
INTERVENTIONAL
2007-11-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
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).
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).
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).
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).
Interventions
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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.
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).
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 Criteria
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Inclusion Criteria
* chronic renal insufficiency with a calculated creatinine clearance below 60 cc /min. (estimated with the MDRD formula)
* hemodynamically stable
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Université de Sherbrooke
OTHER
Responsible Party
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Michel Nguyen
Doctor
Principal Investigators
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Michel Nguyen, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Sherbrooke University
Locations
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CHUS, clinical research center
Sherbrooke, Quebec, Canada
Countries
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Central Contacts
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Other Identifiers
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03-70-M5
Identifier Type: -
Identifier Source: org_study_id
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