A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia
Primary Purpose
Kidney Diseases, Contrast Media Reaction
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sodium bicarbonate
N-acetylcysteine
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Diseases focused on measuring Acetylcysteine, Sodium Bicarbonate, Lipocalins, Creatinine, Blood Urea Nitrogen
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
control
Sodium bicarbonate
N-acetylcysteine plus Sodium bicarbonate
Arm Description
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
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.
Outcomes
Primary Outcome Measures
renal function before and after diagnostic procedure by measuring Serum creatinine in µmol/mL
measure of serum creatinine before and after diagnostic procedure
Secondary Outcome Measures
blood urea nitrogen in mmol/L
measure of blood urea nitrogen before and after diagnostic procedure
neutrophil gelatinase-associated lipocalin in ng/mL
measure of neutrophil gelatinase-associated lipocalin before and after diagnostic procedure
Full Information
NCT ID
NCT02761577
First Posted
April 29, 2016
Last Updated
May 2, 2016
Sponsor
Clinical Hospital Centre Zagreb
1. Study Identification
Unique Protocol Identification Number
NCT02761577
Brief Title
A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia
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 Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Hospital Centre Zagreb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Contrast Media Reaction
Keywords
Acetylcysteine, Sodium Bicarbonate, Lipocalins, Creatinine, Blood Urea Nitrogen
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
perorally 1500 ml water on the day of the procedure
Arm Title
Sodium bicarbonate
Arm Type
Experimental
Arm Description
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
Arm Title
N-acetylcysteine plus Sodium bicarbonate
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sodium bicarbonate
Other Intervention Name(s)
NaHCO3
Intervention Description
3 mL/kg/hour of Sodium bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Other Intervention Name(s)
fluimukan
Intervention Description
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
Primary Outcome Measure Information:
Title
renal function before and after diagnostic procedure by measuring Serum creatinine in µmol/mL
Description
measure of serum creatinine before and after diagnostic procedure
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
blood urea nitrogen in mmol/L
Description
measure of blood urea nitrogen before and after diagnostic procedure
Time Frame
48 hours
Title
neutrophil gelatinase-associated lipocalin in ng/mL
Description
measure of neutrophil gelatinase-associated lipocalin before and after diagnostic procedure
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia
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