Contrast Medium-induced Nephropathy
Conditions
Keywords
Contrast, nephropathy, cardiac catheterization, angiography, percutaneous coronary intervention is
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.
Interventions
OTHERLVEDP -Based hydration strategy
OTHERStandard hydration
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Contrast induced nephropathy | Within four days of contrast exposure |
Secondary
| Measure | Time frame |
|---|---|
| Renal replacement therapy, myocardial infarction, all-cause mortality | 30 days and long-term |
Countries
United States
Outcome results
None listed