contrast-induced nephroathy MedDRA version: 17.0 Level: PT Classification code 10010836 Term: Contrast media reaction System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 17.0 Level: PT Classification code 10029155 Term: Nephropathy toxic System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: sodium bicarbonate 1.4% i.v.
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: sodium bicarbonate 14.0 g
CAS Number: 144-55-8
Current Sponsor code: sodium bicarbonate 1.4%
Sponsors
"G. d'Annunzio" University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Consecutive patients scheduled for coronary angiography and/or angioplasty will be considered for enrollment. Patients will be considered eligible if having: • age =18 years; • eGFR 15 mL/min/1.73 m2 (MDRD formula). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
Exclusion criteria: • acute renal insufficiency; • emergency catheterization (e.g., STEMI patients) preventing the possibility of pretreatments; • a history of adverse reactions to contrast media; • use of potentially nephrotoxic drugs (non-steroidal anti-inflammatory drugs, aminoglycosides, sulphonamides, ciclosporin, tacrolimus, methotrexate or platinum complexes) from 48 hours before to 24 hours after the procedure, but allowing drugs deemed essential for cardiovascular therapy (diuretics, acetylsalicylic acid, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers or aliskiren); • pulmonary edema; • multiple myeloma and other monoclonal gammopathies; • factors predisposing to kidney injury: diarrhea, vomiting, dehydration or bleeding; • exposure to contrast media within 7 days before the procedure; • pregnancy; • use of N-acetyl cysteine, teophylline, dopamine, fenoldopam, mannitol, citrate or bicarbonate within 48 hours before coronary angiography; • urinary tract infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We will test the hypothesis that both oral and i.v. bicarbonate are adequate strategies for Contrast Induced Nephropathy (CIN) prevention in patients after coronary angiography. Comparing the incidence of CIN according to urine pH achieved immediately before angiography, we aim at demonstrating that urine alkalinization is the real goal, and that results are here largely independent from the strategy adopted to achieve this goal. We will therefore compare the efficacy in alkalinizing urine and preventing CIN of three different strategies: hydration alone; hydration plus i.v. sodium bicarbonate; and hydration plus oral bicarbonate. ;Secondary Objective: non-inferiority results of the oral group compared to i.v. bicarbonate group in alkalinizing urine and preventing CIN;Primary end point(s): The incidence of CIN, according to urine alkalinization achieved immediately before angiography (cut-off pH >6). Our primary hypothesis is that the incidence of CIN according to the above definition is significantly different in patients achieving urine alkalinization compared with patients not achieving it.;Timepoint(s) of evaluation of this end point: 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 48 hours;Secondary end point(s): - the mean change of urine pH from hospital admission to the time of coronary angiography, to compare the capability of the three strategies to alkalinize urine. Our hypothesis is that the proportion of patients achieving urine alkalinization (pH>6) will be greater in patientsallocated to the sodium bicarbonate group or oral sodium/potassium citrate group compared to control group; - the incidence of CIN in three treatment groups. Our hypothesis is that the proportion of patients that develop a CIN will be greater in patients allocated to control group respect to patients assigned to other groups; - non-inferiority comparison between oral sodium bicarbonate group and i.v. sodium bicarbonate group. The non-inferiority of oral bicarbonate group respect to i.v. sodium bicarbonate group will be evaluated in term of incidence of CIN and proportion of patients achieving urine alkalinization. | — |
Countries
Italy
Contacts
Public ContactDept. of Neuroscience and Imaging
"G. d'Annunzio" University
Outcome results
None listed