cystic fibrosis cystische fibrose kidney damage nierschade
Conditions
Interventions
Subjects will be randomized to receive their daily dose of tobramycin in the morning or in the evening.
Sponsors
Haga Medical Center, The Hague
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: ≥ 18 years; 2. A diagnosis of cystic fibrosis (ie, sweat chloride ≥ 60 mmol/L or a genotype associated with cystic fibrosis); 3. Chronic infection with Pseudomonas aeruginosa with the most recently isolated organism showing sensitivity to tobramycin; 4. Pulmonary exacerbation as defined by Fuchs and colleagues.
Exclusion criteria
Exclusion criteria: 1. Use of nephrotoxic drugs (NSAID´s, furosemide, vancomycin); 2. Allergy for aminoglycosides; 3. Granulocytopenia (<1,0 x 109/L); 4. Pregnancy; 5. Calculated GFR < 40 ml/min; 6. Pre-existing hearing impairment (≥ 20 dB hearing level at any two frequencies between 2kHz and 8 kHz on the standard audiogram).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the renal clearance of tobramycin in CF patients receiving a daily intravenous dose in the morning against patients receiving a daily intravenous dose of tobramycin in the evening. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare biochemical parameters of kidney function in patients who receive a dose of tobramycin in the morning against patients who receive a dose of tobramycin in the evening. | — |
Contacts
Public ContactErik Maarseveen, van
PO Box 85.500
Outcome results
None listed