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Evaluation of the possible renal impairment following iodium containing solutions administration in radiography

Evaluation of the risk of nephrotoxicity caused by the intravenous administration of nonionic iodinated contrast media

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-004742-16-IT
Enrollment
Unknown
Registered
2012-10-30
Start date
2013-01-04
Completion date
Unknown
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The present study was designed to determine the incidence of serious complications with special reference to contrast induced nephropaty (CIN) in patients receiving iv iodinated contrast media (ICM) and to define the risk factors for CIN in these subjects.

Interventions

Pharmaceutical Form: Solution for injection INN or Proposed INN: IOMEPROL CAS Number: 78649-41-9 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 300-3

Sponsors

AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All the patients receiving ICM by the iv route will be considered for the analysis. The study includes special populations: children (13-17 y);elderly (65-74 y); elderly (75+ y); pregnant women/brestfeeding. Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2850 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: na

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine the total prevalence of CIN in patients receiving ICM by the iv route regardless of the clinical indication and of the type of radiological investigation performed; to identify the factors critically influencing the chance of developing CIN after iv ICM administration;Secondary Objective: na;Primary end point(s): a- To accurately determine the total incidence of CIN in patients receiving ICM by the iv route regardless of the clinical indication and from the type of radiological investigation performed; b- to evaluate if patient's age and preexisting renal disease significantly influence the chance of developing CIN after iv ICM administration. The following contrast media will be studied: iomeprol, iopamidol, iopromide, iobitridol.;Timepoint(s) of evaluation of this end point: 36 months—

Secondary

MeasureTime frame
Secondary end point(s): na;Timepoint(s) of evaluation of this end point: na—

Countries

Italy

Contacts

Public ContactDipScienzeBiomedicheSanitàPubblica

Università Politecnica delle Marche

s.amoroso@univpm.it071-2206176

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026