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

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

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

Study Overview

• Status: Completed
• Conditions: Kidney Diseases; Contrast Media Reaction
• Intervention / Treatment: Drug: Sodium bicarbonate; Drug: N-acetylcysteine

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; perorally 1500 ml water on the day of the procedure
Experimental: 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	Drug: Sodium bicarbonate; 3 mL/kg/hour of Sodium bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography; Other Names: NaHCO3
Experimental: N-acetylcysteine plus 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.	Drug: Sodium bicarbonate; 3 mL/kg/hour of Sodium bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography; Other Names: NaHCO3; Drug: 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; Other Names: fluimukan

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clinical Hospital Centre Zagreb

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: May 2, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Estimate): May 4, 2016
• Last Update Submitted That Met QC Criteria: May 2, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Acetylcysteine; Sodium Bicarbonate; Creatinine; Blood Urea Nitrogen; Lipocalins
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: 16012011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED