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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Hydratation according LVEDP + NaHCO3 | Experimental | 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 | Active Comparator | 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 | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydratation according LVEDP + NaHCO3 | Other | 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. |
| Measure | Description | 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 |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michel Nguyen, MD, FRCPC | Contact | 819 346-1110 | 15251 | michel.nguyen@usherbrooke.ca |
| Name | Affiliation | Role |
|---|---|---|
| Michel Nguyen, MD, FRCPC | Sherbrooke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUS, clinical research center | Recruiting | Sherbrooke | Quebec | J1H 5N4 | Canada |
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|
| normal saline | Other | 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 | Other | 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). |
|
| Incidence of contrast nephropathy defined as an increase of 25% of the creatinine value at 48 hours |
| 48 hours |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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