Replacement Therapy, RenalPhA-SLEDNCT02287493
Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)
An observational study of Replacement Therapy, Renal, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Replacement Therapy, Renal
- What is being tested?
- Pharmacokinetic Analysis
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Dec 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult ICU patients at University Medical Center Hamburg-Eppendorf receiving SLED and either meropenem or ceftazidim.
Who may be able to join
- age: 18 or older
- patients receiving SLED and either meropenem or ceftazidim
Who cannot join
- missing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
In a prospective, non-interventional, monocentric observational study the pharmacokinetic properties of selected antiinfective drugs during sustained low-efficiency dialysis (SLED) will be analyzed.
Read the 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
- Conditions
- Replacement Therapy, Renal
- Being tested
- Pharmacokinetic Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetic AnalysisOther
| Study group | Role | What they receive |
|---|---|---|
| Meropenem | Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics. Receives: Other: Pharmacokinetic Analysis | |
| Ceftazidim | Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics. Receives: Other: Pharmacokinetic Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC)
Plasma concentrations of meropenem or ceftazidim by the end of SLED therapy. Meropenem and ceftazidim are often used for empirical treatment also targeting for Pseudomonas aeruginosa (PSA) infections.
Therefore, minimal targeted concentrations were set to the MIC of 2 mg/l for meropenem and to the MIC of 4 mg/L for ceftazidime treatment according to the breakpoints of PSA strains.
Measured: days receiving SLED, up to 5 days
Secondary outcomes (3)
Mortality
ICU mortality
Measured: minimum duration of hospital stay, maximum 1 year
Length of Stay (LOS)
Length of stay at the ICU and in hospital
Measured: minimum duration of hospital stay, maximum 1 year
Number of Patients With Clinical Cure of Infections
Clinical response to antibiotic treatment assessed by laboratory parameters such as leucocyte count, c-reactive protein or procalcitonin levels as well as vasopressor support
Measured: minimum duration of hospital stay, maximum 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startJul 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Replacement Therapy, RenalStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. rer. medic. Claudia Langebrake, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Stefan Kluge, Prof. Dr., Principal investigator, University Medical Center Hamburg-Eppendorf, Department of Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287493
- Sponsor's protocol ID
- PV4244
- Acronym
- PhA-SLED
- Status last verified
- Dec 2021
- First submitted
- 30 Oct 2014
- Last updated
- 14 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Braune S, Konig C, Roberts JA, Nierhaus A, Steinmetz O, Baehr M, Kluge S, Langebrake C. Pharmacokinetics of meropenem in septic patients on sustained low-efficiency dialysis: a population pharmacokinetic study. Crit Care. 2018 Jan 30;22(1):25. doi: 10.1186/s13054-018-1940-1.
PubMed 29382394
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)
- ClinicalTrials.gov ID
- NCT02287493
- Acronym / sponsor ID
- PhA-SLED / PV4244
- Conditions
- Replacement Therapy, Renal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Posted 18 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meropenem | – | Other: Pharmacokinetic AnalysisAdult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics. |
| Ceftazidim | – | Other: Pharmacokinetic AnalysisAdult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients at University Medical Center Hamburg-Eppendorf receiving SLED and either meropenem or ceftazidim.
Key inclusion criteria (2 listed)
- age: 18 or older
- patients receiving SLED and either meropenem or ceftazidim
Key exclusion criteria (1 listed)
- missing informed consent
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 |
|---|---|---|
| Pharmacokinetic Analysis | Other | Ceftazidim, Meropenem |
Primary outcome
Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC)
Time frame: days receiving SLED, up to 5 days
Plasma concentrations of meropenem or ceftazidim by the end of SLED therapy. Meropenem and ceftazidim are often used for empirical treatment also targeting for Pseudomonas aeruginosa (PSA) infections. Therefore, minimal targeted concentrations were set to the MIC of 2 mg/l for meropenem and to the MIC of 4 mg/L for ceftazidime treatment according to the breakpoints of PSA strains.
3 secondary outcomes
Mortality
Time frame: minimum duration of hospital stay, maximum 1 year
Length of Stay (LOS)
Time frame: minimum duration of hospital stay, maximum 1 year
Number of Patients With Clinical Cure of Infections
Time frame: minimum duration of hospital stay, maximum 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29382394Braune S, Konig C, Roberts JA, Nierhaus A, Steinmetz O, Baehr M, Kluge S, Langebrake C. Pharmacokinetics of meropenem in septic patients on sustained low-efficiency dialysis: a population pharmacokinetic study. Crit Care. 2018 Jan 30;22(1):25. doi: 10.1186/s13054-018-1940-1.
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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.
Stefan Kluge, Prof. Dr. principal investigator
University Medical Center Hamburg-Eppendorf, Department of Intensive Care
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 Replacement Therapy, Renal, run by Universitätsklinikum Hamburg-Eppendorf 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 2 inclusion and 1 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 14 Dec 2021. 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?
Yes. Results are posted in the registry (first posted 18 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC) (time frame: days receiving SLED, up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02287493, which also lists 1 linked publication.
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 14 Dec 2021.