Prevention of renal insufficiency caused by contrast medium

Phase 1

• Conditions: contrast-induced nephroathy; MedDRA version: 17.0Level: PTClassification code 10010836Term: Contrast media reactionSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 17.0Level: PTClassification code 10029155Term: Nephropathy toxicSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2014-001838-29-IT
• Lead Sponsor: G. d'Annunzio University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-04
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

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 <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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified