Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-20 @ 8:09 PM
Study NCT ID:
NCT02287493
Status:
COMPLETED
Last Update Posted:
2021-12-14
First Post:
2014-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Study Overview
Official Title:
Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PhA-SLED
Brief Summary:
In a prospective, non-interventional, monocentric observational study the pharmacokinetic properties of selected antiinfective drugs during sustained low-efficiency dialysis (SLED) will be analyzed.
Detailed Description:
Antibiotic concentrations are measured whilst patients receive SLED for renal replacement therapy. The plasma specimens will be quantified using high Performance liquid chromatography (HPLC).
Primary endpoint:
\- Plasma levels of antiinfectives during SLED
Secondary endpoints:
* mortality
* length of stay at the intensive care unit (ICU) and hospital
* clinical cure of infections
Inclusion criteria:
* age: \> 18 years
* patients under SLED
* antiinfective treatment
exclusion criteria:
\- missing informed consent
Primary endpoint:
\- Plasma levels of antiinfectives during SLED
Secondary endpoints:
* mortality
* length of stay at the intensive care unit (ICU) and hospital
* clinical cure of infections
Inclusion criteria:
* age: \> 18 years
* patients under SLED
* antiinfective treatment
exclusion criteria:
\- missing informed consent
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: