No registrations found.
ID
Source
Health condition
Selective Decontamination of the Digestive tract (SDD), Intensive Care Unit (ICU)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Achieving high (> 1,0 mg/L) tobramycin serum concentrations during the use of SDD.
Secondary outcome
Identification of risk factors that contribute to high systemic serum tobramycin concentrations. To this end, we extract data from the patient record in Chipsoft.
Background summary
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.
Study objective
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.
Study design
Blood will be taken from the patient on days 3, 7, 10 and 14 after the start of SDD
Intervention
None
Klinische Farmacie
Jildou de Zee
Van Swietenplein 1
Groningen 9728 NT
The Netherlands
050-5246783
J.deZee@mzh.nl
Klinische Farmacie
Jildou de Zee
Van Swietenplein 1
Groningen 9728 NT
The Netherlands
050-5246783
J.deZee@mzh.nl
Inclusion criteria
- Signed Informed Consent
- Patient has to lie on the ICU or Medium Care ICU
- Patient has to use SDD
Exclusion criteria
- 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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5541 |
| NTR-old | NTR5661 |
| CCMO | NL55838.099.15 |
| OMON | NL-OMON43386 |