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.
Conditions
Interventions
Trade Name: Iodixanol (VisipaqueTM 320)
Product Name: VisipaqueTM 320
Pharmaceutical Form: Injection*
INN or Proposed INN: Iodixanol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration typ
Sponsors
Charité/Campus Virchow-Klinikum, Medizinische Klinik m. S. Kardiologie
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - age < 18 years - stenosis of renal artery - life expectancy below 6 months - insufficient German language skills - chronic renal replacement therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed