The purpose of this study is to provide insight into what extent clinically significant systemic absorption of tobramycin occurs (resulting in a serum tobramycin concentration >1,0 mg/L) in ICU and Medium Care ICU patients who are being treated…
ID
Bron
Aandoening
Selective Decontamination of the Digestive tract (SDD), Intensive Care Unit (ICU)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Achieving high (> 1,0 mg/L) tobramycin serum concentrations during the use of SDD.
Achtergrond van het onderzoek
SDD is used to prevent infections in ICU patients. It is applied in the mouth and directly in the stomach. There should be no absorption of the SDD components (tobramycin, colistin and amphotericin B), so no serum concentrations are to be expected. However patients with detectable tobramycin serum concentrations have been reported.
This study is an observational cohort study. By taking blood from all patients in the ICU who receive SDD treatment, we want to gain insight into what extent clinically significant systemic absorption of tobramycin occurs and to identify possible risk factors that may contribute to an increased risk of absorption of tobramycin.
Doel van het onderzoek
The purpose of this study is to provide insight into what extent clinically significant systemic absorption of tobramycin occurs (resulting in a serum tobramycin concentration >1,0 mg/L) in ICU and Medium Care ICU patients who are being treated with SDD. In addition, the goal of this research is to gain insight into risk factors that may contribute to an increased risk of absorption of tobramycin in the use of SDD.
Onderzoeksopzet
Blood will be taken from the patient on days 3, 7, 10 and 14 after the start of SDD
Onderzoeksproduct en/of interventie
None
Algemeen / deelnemers
Klinische Farmacie
Jildou de Zee
Van Swietenplein 1
Groningen 9728 NT
The Netherlands
050-5246783
J.deZee@mzh.nl
Wetenschappers
Klinische Farmacie
Jildou de Zee
Van Swietenplein 1
Groningen 9728 NT
The Netherlands
050-5246783
J.deZee@mzh.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Signed Informed Consent
- Patient has to lie on the ICU or Medium Care ICU
- Patient has to use SDD
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Patients that are admitted to the burns ICU
- Patients concurrently or within 72 hours prior to SDD treatment receiving tobramycin administered parenterally or pulmonary
- Patients who aren't treated with the regular schedule
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5541 |
| NTR-old | NTR5661 |
| CCMO | NL55838.099.15 |
| OMON | NL-OMON43386 |