Renal haemodynamics during application of contrast media in patients undergoing cardiac catheterisation with high risk of acute renal failure: randomized comparison of different contrast media - RenalFlowH

Phase 1

Conditions: Patients with allready existing chronic renal failure undergoing a cardiac catheterisation for clinical reasons may develope an acute renal failure due to radio contrast media. This trial compares three different authorised contrast media which are generally used in clinical practice and applied in this patient population. Renal haemodynamic measurements during the catherisation will be performed to detect specific differences among the contrast media.

Registration Number: EUCTR2004-005172-17-DE

Lead Sponsor: Charité/Campus Virchow-Klinikum, Medizinische Klinik m. S. Kardiologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

- clinical need for left ventricular (LV) and coronary angiography with or without percutaneous intervention (depending on the result of the diagnostic study)
- chronic renal failure with GFR < 50ml/min
- informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- age < 18 years
- stenosis of renal artery
- life expectancy below 6 months
- insufficient German language skills
- chronic renal replacement therapy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To detect differences of the hemodynamic effects of 3 approved contrast media.;Secondary Objective: Creatinin levels before and after 48 hours and 7 days after cardiac catheterisation; clinical adverse events including need for renal replacement therapy (RRT).;Primary end point(s): Integral of renal flow velocity after contrast media application

Secondary Outcome Measures