Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Acute Kidney Failure
- Sponsor
- Universidad de Antioquia
- Enrollment
- 212
- Locations
- 1
- Primary Endpoint
- development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
Deterioration of kidney renal function occurs in a minority of people due to contrast-required procedures. The purpose of this study is to compare two different interventions to reduce the risk of kidney injury after contrast medium exposition.
We will perform a randomized clinical trial following a modification of a previously published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure.
Detailed Description
We will perform a randomized clinical trial following a modification of a previously published protocol (Merten et al.JAMA 2004;291(19):2328-34). Patients will be randomly assigned to one of two groups of treatment. Group A will receive 1 cc/kg/hour of 0.9% saline infusion starting 12 hours before and continuing 12 hours after the procedure. Group B will receive 3 cc/kg of sodium bicarbonate solution for one hour prior to procedure, then drip rate will be decreased to 1 cc/kg/hour until 6 hours post procedure. Phase 2/3 study Study Type: Interventional Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study. Subjects: Consecutive samples of all inpatients who meet the inclusion criteria Primary outcomes: Development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast. Secondary outcomes: change in serum bicarbonate; change in serum potassium; change in serum creatinine. Expected total enrollment: 212 Allocation Assignment: Patients who meet inclusion criteria and agree to participate in the study will be assigned by a random number table to saline or bicarbonate, using closed envelopes and stratifying according to history of diabetes and type of procedure (cardiac catheterism or others). Condition: Contrast Induced Nephropathy Intervention: 75 cc of sodium bicarbonate (8.4%) mixed in 425 cc of D5W Gender: both Age: 18+ years of age Recruitment Status: participants are currently being recruited Facility location: Universidad de Antioquia, Internal Medicine Department; Hospital Universitario San Vicente de Paul. Medellin, Colombia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18+ years of age
- •Inpatient at Hospital Universitario San Vicente de Paúl scheduled to undergo diagnostic CT scan using contrast or angiography and either
- •Serum creatinine 1.2 mg/dl or more, or
- •Type 2 Diabetes Mellitus
Exclusion Criteria
- •Current clinical diagnosis of exacerbated congestive heart failure
- •Exposure to contrast 30 days prior to study
- •Allergy to contrast dye
- •Chronic renal disease with dialysis therapy
- •Acute renal failure with dialytic urgency
- •Urgency procedure needed
- •Systolic blood pressure \< 90 or vasopressor support
- •No authorization by patient or physician in charge
- •Serum potassium \< 3 mEq/L
- •Ejection fraction \< 35% by previous echocardiography
Outcomes
Primary Outcomes
development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast
Time Frame: 48 h
Secondary Outcomes
- change in serum bicarbonate; change in serum potassium; change in serum creatinine(48 h)