The efficacy of oral administration of sodium chloride in the prophylaxis of nephropathy induced by iodinated contrasts

Phase 1

• Conditions: Patients at high risk of developing an iodinated contrast-induced nephropathy.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-001229-15-ES
• Lead Sponsor: Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-26
• Last Update Posted: 11 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 266

Inclusion Criteria

Patients will undergo performing contrast CT, as indicated by clinical practice, and after being informated, agree to participate and sign the written consent to participate in the study , and meet the following criteria:

Age over 65 years

One of the following risk factors for NIC: diabetes mellitus, stable heart failure or kidney failure (estimated glomerular filtration rate calculated by the MDRD-4 between 30 and 60 ml / min)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 266

Exclusion Criteria

Glomerular filtration rate below 30 ml / min.

Presence of hypokalemia (serum potassium less than 3.5 mEq / L).
Other procedures with intravenous contrast in the 15 previous days.

Administration of nephrotoxic drugs (NSAIDs, aminoglycosides and / or potentially nephrotoxic chemotherapy) in the previous72 hours, or after the treatment.

Study & Design

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