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

Clinical Hospital Centre Zagreb

Status and phase: Completed; Phase 4

Conditions: Kidney Diseases; Contrast Media Reaction

Treatments: Drug: N-acetylcysteine; Drug: Sodium bicarbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT02761577

16012011

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

control

No Intervention group

Description:

perorally 1500 ml water on the day of the procedure

Sodium bicarbonate

Experimental group

Description:

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

Treatment:

Drug: Sodium bicarbonate

N-acetylcysteine plus Sodium bicarbonate

Experimental group

Description:

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.

Treatment:

Drug: N-acetylcysteine

Drug: Sodium bicarbonate