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Tobramycine absorptie bij SDD


- candidate number23666
- NTR NumberNTR5661
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-jan-2016
- Secondary IDsNL55838.099.15 
- Public TitleTobramycine absorptie bij SDD
- Scientific TitleDetermination of tobramycin serum concentrations in ICU patients treated with SDD: a prospective study
- ACRONYM
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedSDD, Intensive care
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 22-feb-2016
- planned closingdate1-jul-2016
- Target number of participants200
- InterventionsNone
- Primary outcomeAchieving high (> 1,0 mg/L) tobramycin serum concentrations during the use of SDD.
- Secondary outcomeIdentification of risk factors that contribute to high systemic serum tobramycin concentrations. To this end, we extract data from the patient record in Chipsoft.
- TimepointsBlood will be taken from the patient on days 3, 7, 10 and 14 after the start of SDD
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Jildou de Zee
- CONTACT for SCIENTIFIC QUERIES Jildou de Zee
- Sponsor/Initiator Martini Hospital Groningen
- Funding
(Source(s) of Monetary or Material Support)
Martini Hospital Groningen
- Publications
- Brief summarySDD 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.
- Main changes (audit trail)
- RECORD28-jan-2016 - 27-nov-2016


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