Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients

Heart Assist Device Clinical Trial

Official title:

Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03004066
• Other study ID #: Dapto
• Status: Completed
• Start date: October 2016
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2018
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

10 patients with chronic heart failure receiving daptomycin therapy after implantation of a left ventricular heart assist system. Measurement of daptomycin levels in drainage fluids (mediastinal and pleural drainage systems) and in blood samples.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• written consent

• heart assist device implantation

• wound drainage

• daptomycin therapy

Exclusion Criteria:

• pregnancy

• no written consent possible

• absence of wound drainage

• allergy to study medication

• acute rhabdomyolysis

Related Conditions & MeSH terms

• Heart Assist Device

Intervention

Drug:
• Daptomycin
standard care

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	levels of Daptomycin in drainage fluid	Pharmacokinetics of Daptomycin in intensive care patients with wound drainage after surgery (LVAD implantation)	4 days
Primary	levels of Daptomycin in blood samples	Pharmacokinetics of Daptomycin in intensive care patients after surgery (LVAD implantation)	4 days
Secondary	infections	incidence of gram-positive infections	14 days