Hydration With Different Sodium Chloride Protocols for the Prevention of Contrast Medium-induced Nephropathy in Patients Undergoing Coronary Angiography: a Randomized Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Contrast Medium-induced Nephropathy
- Sponsor
- Kaiser Permanente
- Enrollment
- 396
- Locations
- 1
- Primary Endpoint
- Contrast induced nephropathy
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Using a randomized controlled trial design, two hydration protocols for the prevention of contrast medium-induced nephropathy will be tested.
Detailed Description
The study population will be recruited from subjects undergoing cardiac catheterization. Subjects will be randomized to one of two hydration protocols: 1. normal saline at 3 mL/kg for one hour prior to contrast exposure and 1.5 mL/kg/hr during and for four hours post procedure. 2. normal saline at 3 mL/kg for one hour prior to contrast exposure and then the fluid rate would be adjusted according to the left ventricular end diastolic pressure (LVEDP). The fluid rate based upon the LVEDP measurement is maintained during the procedure and for four hours post procedure. The LVEDP hydration strategy follows: (2A) \< 13 mmHg, 5 mL/kg/hr during and for four hours post procedure. (2B) 13-18 mmHg, 3 mL/kg during and for four hours post procedure. (2C) \> 18 mmHg, 1.5 mL/kg during and four hours post procedure. Renal function assessment will be made using standard laboratory measures post procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •estimated GFR less than or equal to 60 mL/min/1.73 m\^2
- •age greater than 18 years
- •at least one of the following: diabetes mellitus, history of congestive heart failure, hypertension, or age greater than 75 years.
Exclusion Criteria
- •patients unable to give consent
- •undergoing emergency cardiac catheterization
- •on renal replacement therapy
- •exposure to contrast media within the prior two days
- •pulmonary edema or active congestive heart failure
- •kidney transplant status
- •severe valvular abnormalities
- •change in serum creatinine greater than 15% over the prior two days
Outcomes
Primary Outcomes
Contrast induced nephropathy
Time Frame: Within four days of contrast exposure
Secondary Outcomes
- Renal replacement therapy, myocardial infarction, all-cause mortality(30 days and long-term)