An observational study in Septic Shock, Fungal Infection and Critical Illness, sponsored by Medical University of Lublin. Completed at 1 site in Poland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-11-24.
Sponsored by Medical University of Lublin · Observational
The objective of this study is to describe the pharmacokinetics of standard doses of caspofungin in critically ill patients.
This is a prospective observational study performed on critically ill patients. Inclusion criteria are: severe sepsis on admission requiring broad-spectrum antibiotics. Both medical and surgical patients will be included. Any type of infections will be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes: broad spectrum anti-bacterial antibiotics plus caspofungin (70 mg i.v. on the first day day, and 50 mg i.v. on the consecutive days, once daily.
Blood samples (3 mL) will be collected 2, 4, 8,12 and 24 hours after each dose of caspofungin for 3 consecutive days. The standard arterial canula will be used to obtain samples.
30 minutes after each sample collection, blood will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.
Serum caspofungin concentration will be measured with high performance liquid chromatography.
Each patient's hemodynamics parameters will be recorded with the use of transpulmonary thermodilution technique (PICCO). Other therapies i.e.: ventilatory support, sedation, an antifungal agent will be given as required.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's enrollment of 33 is below the median of 108 across 406 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Medical University of Lublin is the lead sponsor of 62 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients admitted to ICU due to severer sepsis recognition. Both medical and surgical patients will be included. Any site of infection will be treated in the manner.
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Exclusion Criteria:
Each patient will receive: caspofungin i.v. once daily ( 70 mg on the first day, 50 mg on the 2 and 3 day
Drug: Caspofungin
Each patient will receive: caspofungin i.v. once daily ( 70 mg on the first day, 50 mg on the 2 and 3 day Blood samples (3 mL) will be collected 2, 4, 8, 12 and 24 hours after each dose of caspofungin for 3 consecutive days.
Also known as: blood collection
Serum concentration of caspofungin
Samples obtain from ICU patients 2, 4, 8 12 and 24hours after each dose of caspofungin for 3 days.
Time frame: 72 hours for each patient from the tigecycline treatment initiation
Plan to share: No
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Medical University of Lublin