A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia
NCT ID: NCT02761577
Last Updated: 2016-05-04
Study Results
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Basic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2012-06-30
2016-04-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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control
perorally 1500 ml water on the day of the procedure
No interventions assigned to this group
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
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 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.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* coronary artery disease
* cardiomyopathy
* valvular disease
* vasculitis
* peripheral arterial disease
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Clinical Hospital Centre Zagreb
OTHER
Responsible Party
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Ana Vujaklija Brajkovic
M.D. PhD
Other Identifiers
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16012011
Identifier Type: -
Identifier Source: org_study_id
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