Coronary Heart Disease, Radiographic Contrast Agent Nephropathy, Renal Failure
Conditions
Keywords
coronary angiogram, percutaneous coronary intervention
Brief 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.
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.
Interventions
OTHERHydratation 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.
OTHERnormal 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).
OTHERSodium 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).
Sponsors
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of contrast nephropathy described as an increase of 44 micromol/L in plasma creatinine 48 hours after the injection of contrast product. | 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| changes in glomerular filtration in the 3 groups (measured with MDRD formula) | 48 hours |
| clinical events during the procedure or after (ex. pulmonary edema) | during hospitalisation |
| Incidence of contrast nephropathy defined as an increase of 25% of the creatinine value at 48 hours | 48 hours |
Countries
Canada
Contacts
Primary ContactMichel Nguyen, MD, FRCPC
Outcome results
None listed