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

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ClinicalTrials.gov Identifier: NCT02761577
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Ana Vujaklija Brajkovic, 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


Condition or disease Intervention/treatment Phase
Kidney Diseases Contrast Media Reaction Drug: Sodium bicarbonate Drug: N-acetylcysteine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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
Study Start Date : June 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: fluimukan




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Ana Vujaklija Brajkovic, M.D. PhD, Clinical Hospital Centre Zagreb
ClinicalTrials.gov Identifier: NCT02761577    
Other Study ID Numbers: 16012011
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ana Vujaklija Brajkovic, Clinical Hospital Centre Zagreb:
Acetylcysteine
Sodium Bicarbonate
Lipocalins
Creatinine
Blood Urea Nitrogen
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes