Nefrotoxicity in cystic fibrosis
Conditions
Interventions
Subjects will be randomized to receive their daily dose of tobramycin in the
morning or in the evening. At present tobramycin is administered randomly
throughout the day.
Sponsors
Groene Hart Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age: * 18 years - a diagnosis of cystic fibrosis (ie, sweat chloride *60 mmol/L or a genotype associated with cystic fibrosis) - chronic infection with Pseudomonas aeruginosa with the most recently isolated organism showing sensitivity to tobramycin. - Pulmonary exacerbation as defined by Fuchs and colleagues.
Exclusion criteria
Exclusion criteria: - use of nephrotoxic drugs (NSAID*s, furosemide, vancomycin) - allergy for aminoglycosides - granulocytopenia (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point will be a significant or non-significant difference in the elimination rate constant (Kel) between CF patients receiving a daily intravenous dose of tobramycin in the morning and CF patients receiving a daily intravenous dose of tobramycin in the evening. | — |
Secondary
| Measure | Time frame |
|---|---|
| biochemical signs of nephrotoxicity (NAG and creatinine) in patients who receive their dose of tobramycin in the morning against patients who receive their dose of tobramycin in the evening. | — |
Countries
Netherlands
Outcome results
None listed