A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia With the Use of Standard Laboratory Measures and Novel Biomarkers

Conditions
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Kidney Diseases, Contrast Media Reaction

Intervention / Treatment
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* Drug: Sodium bicarbonate
* Drug: N-acetylcysteine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>perorally 1500 ml water on the day of the procedure | |
| Experimental: Sodium bicarbonate<br>3 mL/kg/hour IV (in vein) of Sodium bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography | Drug: Sodium bicarbonate<br>* 3 mL/kg/hour of Sodium bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography<br>* Other names: NaHCO3;|
| Experimental: N-acetylcysteine plus Sodium bicarbonate<br>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 in addition to Sodium bicarbonate solution on the day of the angiography. | Drug: Sodium bicarbonate<br>* 3 mL/kg/hour of Sodium bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography<br>* Other names: NaHCO3;Drug: N-acetylcysteine<br>* 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<br>* Other names: fluimukan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function before and after diagnostic procedure by measuring Serum creatinine in µmol/mL | measure of serum creatinine before and after diagnostic procedure | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood urea nitrogen in mmol/L | measure of blood urea nitrogen before and after diagnostic procedure | 48 hours | 
| neutrophil gelatinase-associated lipocalin in ng/mL | measure of neutrophil gelatinase-associated lipocalin before and after diagnostic procedure | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetylcysteine, Sodium Bicarbonate, Lipocalins, Creatinine, Blood Urea Nitrogen