A Phase 4 interventional study of Sodium bicarbonate and N-acetylcysteine in Kidney Diseases and Contrast Media Reaction, sponsored by Clinical Hospital Centre Zagreb. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-04.
Sponsored by Clinical Hospital Centre Zagreb · Phase 4, Interventional, and Prevention
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
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 90 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Clinical Hospital Centre Zagreb is the lead sponsor of 31 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
perorally 1500 ml water on the day of the procedure
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
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 · Drug: N-acetylcysteine
3 mL/kg/hour of Sodium bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography
Also known as: NaHCO3
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
Also known as: fluimukan
renal function before and after diagnostic procedure by measuring Serum creatinine in µmol/mL
measure of serum creatinine before and after diagnostic procedure
Time frame: 48 hours
blood urea nitrogen in mmol/L
measure of blood urea nitrogen before and after diagnostic procedure
Time frame: 48 hours
neutrophil gelatinase-associated lipocalin in ng/mL
measure of neutrophil gelatinase-associated lipocalin before and after diagnostic procedure
Time frame: 48 hours
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Clinical Hospital Centre Zagreb