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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP

Conditions
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Radiographic Contrast Agent Nephropathy, Renal Failure, Coronary Heart Disease

Intervention / Treatment
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* Other: Hydratation according LVEDP + NaHCO3
* Other: normal saline
* Other: Sodium bicarbonate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Hydratation according LVEDP + NaHCO3<br>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<br>* 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.<br>|
| Active Comparator: B: Standard hydratation<br>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<br>* 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).<br>|
| Experimental: C: Hydratation with sodium bicarbonate<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Incidence of contrast nephropathy defined as an increase of 25% of the creatinine value at 48 hours |  | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary angiogram, percutaneous coronary intervention