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

G. d'Annunzio University0 个研究点目标入组 240 人开始时间: 2014年7月4日最近更新: 2018年3月19日

试验速览

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•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;
•urinary tract infection.

发起方

G. d'Annunzio University