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

Phase 4

Completed

• Conditions: Kidney Diseases; Contrast Media Reaction
• Interventions: Drug: Sodium bicarbonate; Drug: N-acetylcysteine

• Registration Number: NCT02761577
• Lead Sponsor: Clinical Hospital Centre Zagreb

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.

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-07
• Study Completion: 2016-04
• Study First Submitted: 2016-04-29
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-02
• Last Update Submitted: 2016-05-02
• Study First Posted: 2016-05-04
• Last Update Posted: 2016-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-acetylcysteine plus Sodium bicarbonate	Sodium bicarbonate	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.
Sodium bicarbonate	Sodium bicarbonate	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
N-acetylcysteine plus Sodium bicarbonate	N-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 in addition to Sodium bicarbonate solution on the day of the angiography.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
neutrophil gelatinase-associated lipocalin in ng/mL	48 hours	measure of neutrophil gelatinase-associated lipocalin before and after diagnostic procedure
blood urea nitrogen in mmol/L	48 hours	measure of blood urea nitrogen before and after diagnostic procedure