Prevention of Contrast Induced Nephropathy With Sodium Bicarbonate
- Conditions
- Acute Kidney Failure
- Registration Number
- NCT00472563
- Lead Sponsor
- Universidad de Antioquia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 212
-
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
- 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
- Acute pulmonary edema in previous 48 hours
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method development of contrast induced nephropathy, defined as an increase in serum creatinine of 25% or more within 48 h after administration of contrast 48 h
- Secondary Outcome Measures
Name Time Method change in serum bicarbonate; change in serum potassium; change in serum creatinine 48 h
Trial Locations
- Locations (1)
Hospital Universitario San Vicente Paúl
🇨🇴Medellín, Antioquia, Colombia