Heart Assist DeviceNCT03004066
Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients
An observational study of Heart Assist Device, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Assist Device
- What is being tested?
- Daptomycin
- How many people
- 9 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2016to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients after heart assist device implantation with wound drainage receiving daptomycin therapy
Who may be able to join
- written consent
- heart assist device implantation
- wound drainage
- daptomycin therapy
Who cannot join
- pregnancy
- no written consent possible
- absence of wound drainage
- allergy to study medication
- acute rhabdomyolysis
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Heart Assist Device
- Being tested
- Daptomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
standard care
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of Daptomycin in drainage fluid
Pharmacokinetics of Daptomycin in intensive care patients with wound drainage after surgery (LVAD implantation)
Measured: 4 days
levels of Daptomycin in blood samples
Pharmacokinetics of Daptomycin in intensive care patients after surgery (LVAD implantation)
Measured: 4 days
Secondary outcomes (1)
infections
incidence of gram-positive infections
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startOct 2016
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Assist DeviceStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefanie Prohaska, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004066
- Sponsor's protocol ID
- Dapto
- Status last verified
- Apr 2018
- First submitted
- 16 Nov 2016
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients
- ClinicalTrials.gov ID
- NCT03004066
- Acronym / sponsor ID
- Dapto
- Conditions
- Heart Assist Device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients after heart assist device implantation with wound drainage receiving daptomycin therapy
Key inclusion criteria (4 listed)
- written consent
- heart assist device implantation
- wound drainage
- daptomycin therapy
Key exclusion criteria (5 listed)
- pregnancy
- no written consent possible
- absence of wound drainage
- allergy to study medication
- acute rhabdomyolysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daptomycinstandard care | Drug | – |
Primary outcome
levels of Daptomycin in drainage fluid
Time frame: 4 days
Pharmacokinetics of Daptomycin in intensive care patients with wound drainage after surgery (LVAD implantation)
levels of Daptomycin in blood samples
Time frame: 4 days
Pharmacokinetics of Daptomycin in intensive care patients after surgery (LVAD implantation)
1 secondary outcome
infections
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Heart Assist Device
Active, not recruiting
Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure
Cardiovascular Diseases, Heart Diseases
RecruitingObservational study
dPmax for Predicting Right Ventricular Failure After Left Ventricular Assist Device Implantation
Ventricular Dysfunction, Right
Recruiting
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
Heart Failure, Heart Diseases
RecruitingPhase 3
SWITCH: Apixaban vs Vitamin K in HM3
LVAD (Left Ventricular Assist Device) Thrombosis, Heart Failure
Not yet recruiting
Out-Patient Proactive Observation With Wearable-Assisted Tracking for Cardiovascular Health Management
Chronic Coronary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefanie Prohaska, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Assist Device, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
levels of Daptomycin in drainage fluid (time frame: 4 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.