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

Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761577
• Other study ID #: 16012011
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2016
• Last updated: May 2, 2016
• Start date: June 2012
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Clinical Hospital Centre Zagreb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia:UHC Zagreb
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2016
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contrast Media Reaction
• Kidney Diseases

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Centre Zagreb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	blood urea nitrogen in mmol/L	measure of blood urea nitrogen before and after diagnostic procedure	48 hours	No
Secondary	neutrophil gelatinase-associated lipocalin in ng/mL	measure of neutrophil gelatinase-associated lipocalin before and after diagnostic procedure	48 hours	No