Circadian Influence on Renal Clearance of Aminoglycosides in cystic fibrosis patients

Completed

Conditions: Nefrotoxicity in cystic fibrosis
10038686
10004018

Registration Number: NL-OMON32697

Lead Sponsor: Groene Hart Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 28

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

- use of nephrotoxic drugs (NSAID*s, furosemide, vancomycin)
- allergy for aminoglycosides
- granulocytopenia (<1,0 x 109/L)
- pregnancy
- calculated GFR < 40 ml/min
- pre-existing hearing impairment ( * 20 dB hearing level at any two frequencies between 2kHz and 8 kHz on the standard audiogram)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end point will be a significant or non-significant difference in<br /><br>the elimination rate constant (Kel) between CF patients receiving a daily<br /><br>intravenous dose of tobramycin in the morning and CF patients receiving a daily<br /><br>intravenous dose of tobramycin in the evening.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>biochemical signs of nephrotoxicity (NAG and creatinine) in patients who<br /><br>receive their dose of tobramycin in the morning against patients who receive<br /><br>their dose of tobramycin in the evening.</p><br>