Contrast Media Reaction, Kidney Diseases
Conditions
Keywords
Acetylcysteine, Sodium Bicarbonate, Lipocalins, Creatinine, Blood Urea Nitrogen
Brief summary
The study is analysis of the incidence of contrast-induced nephropathy (CIN) in patients with previously normal renal function undergoing angiography and comparison between the three different treatment protocols on renal function. Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate (NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion. Serum creatinine (SCr), blood urea nitrogen (BUN), and neutrophil gelatinase-associated lipocalin (NGAL) are measured before and 48 hours after the angiography. CIN was defined as an absolute increase of 0.5 mg/dL or a relative increase of \>25% in creatinine levels 48-72 hours after the procedure
Detailed description
Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate (NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion The first group of patients receives standard peroral hydration of 1500 ml water on the day of the procedure. The second group receives 3 mL/kg/hour of Na bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography. The third group receives parenteral NAC (1200 mg twice a day) one day before angiography, on the day of the angiography, and one day after the diagnostic procedure in addition to Na bicarbonate solution on the day of the angiography. The low-osmolar iodinated contrast agent was used.
Interventions
DRUGSodium bicarbonate
3 mL/kg/hour of Sodium bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography
DRUGN-acetylcysteine
N-acetylcysteine (1200 mg twice a day, IV (in vein) ) one day before angiography, on the day of the angiography, and one day after the diagnostic procedure
Sponsors
Clinical Hospital Centre Zagreb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* angina (stable, unstable) * coronary artery disease * cardiomyopathy * valvular disease * vasculitis * peripheral arterial disease
Exclusion criteria
* kidney dysfunction * uncontrolled hypertension (systolic blood pressure \>160 mm Hg and/or diastolic blood pressure \>100 mm Hg) * pregnancy * lactation * history of allergic reaction to contrast agents * cardiogenic shock * pulmonary edema * multiple myeloma * urgent coronary angiography * receiving contrast agents two days prior to the study and 48 hours within the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| renal function before and after diagnostic procedure by measuring Serum creatinine in µmol/mL | 48 hours | measure of serum creatinine before and after diagnostic procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood urea nitrogen in mmol/L | 48 hours | measure of blood urea nitrogen before and after diagnostic procedure |
| neutrophil gelatinase-associated lipocalin in ng/mL | 48 hours | measure of neutrophil gelatinase-associated lipocalin before and after diagnostic procedure |
Outcome results
None listed