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NCT Number: NCT02761577

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

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

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Key information

Conditions

Kidney Diseases Contrast Media Reaction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium bicarbonate

Drug

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

N-acetylcysteine

Drug

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

Primary outcomes

  1. renal function before and after diagnostic procedure by measuring Serum creatinine in µmol/mL

    Time frame: 48 hours

    measure of serum creatinine before and after diagnostic procedure

Secondary outcomes

  1. blood urea nitrogen in mmol/L

    Time frame: 48 hours

    measure of blood urea nitrogen before and after diagnostic procedure

  2. neutrophil gelatinase-associated lipocalin in ng/mL

    Time frame: 48 hours

    measure of neutrophil gelatinase-associated lipocalin before and after diagnostic procedure

Sponsors and collaborators

Lead sponsor

Clinical Hospital Centre Zagreb

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2016
First posted
May 4, 2016
Registry last updated
May 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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