PrevenTion of contrast-inducEd nephroAThy with urinE alkalinization: the TEATE study

G. d'Annunzio University0 sites240 target enrollmentJuly 4, 2014

Overview

No summary available.

Registry

who.int

Start Date

July 4, 2014

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

G. d'Annunzio University

•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 \<60 mL/min/1\.73 m2, but \>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

•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;