Need for Renal Replacement Therapy and Anti-infective Therapy Due to Severe InfectionNCT02242721
Drugmonitoring of Antiinfective Drugs in Patients Receiving Continous Veno-venous Hemodiafiltration (ABx-CVVHDF)
An observational study of Need for Renal Replacement Therapy and Anti-infective Therapy Due to Severe Infection, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
Approximately 300 patients have to be enrolled in the study. They are followed up until the end of ICU stay. Usually in clinical routine, patients suspected to have infection and simultaneously renal dysfunction making CVVHDF necessary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Need for Renal Replacement Therapy and Anti-infective Therapy Due to Severe Infection
- How many people
- 0 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2014to Jan 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critical ill patients
Who may be able to join
- Male and female patients, age ≥ 18 years
- Patients in the intensive care unit (ICU), needing renal replacement therapy due to renal dysfunction and are treated with antiinfective drugs
Who cannot join
- Pregnancy and lactation period.
- Participation in a clinical intervention study
- Lacking willingness to save and hand out data within the study
- Accommodation in an institution due to an official or judicial order
- The informed consent of the patient or the subject's legally acceptable representative can´t be obtained in time
- Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Medical Department, Division of Nephrology, Campus Charité Mitte, Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
Pharmacy, Kliniken Landkreis Heidenheim gGmbH
Heidenheim, Heidenheim, 89522
About this study
Official title: Drugmonitoring of Antiinfective Drugs in Patients Receiving Continous Veno-venous Hemodiafiltration
Approximately 300 patients have to be enrolled in the study. They are followed up until the end of ICU stay. Usually in clinical routine, patients suspected to have infection and simultaneously renal dysfunction making CVVHDF necessary. After enrolment blood and dialysate specimens are drawn and sent for analysis on specific time points. The analysis results are sent back to the study team at the Charité - Universitätsmedizin Berlin and enable them to optimize antiinfectiva treatment of the study patients.
Data are used to test calculation tools and modify them if necessary.
Read the detailed description
Little data exist whether desired and necessary blood levels of antiinfective drugs are reached during renal replacement therapy. Drug producing companies are not able to come forward with appropriate dosing recommendation in patients needing renal replacement therapy.
To achieve our study goal we plan:
- To measure serum-concentrations of antiinfective drugs applied to the patients
- To measure concentrations of antiinfective drugs in hemofiltration fluids.
- To compare the actual measured concentrations with concentration predicted in known calculation tools.
- To modify these calculation tools if necessary for better prediction.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intensive care unit patients needing renal replacement therapy | Male and female patients in the intensive care unit (ICU), needing renal replacement therapy due to renal dysfunction and are treated with antiinfective drugs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic clearance (l/h)
Measured: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Secondary outcomes (1)
28-day mortality
Measured: The 28-days mortality will be assessed on the 28th study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Need for Renal Replacement Therapy and Anti-infective Therapy Due to Severe InfectionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242721
- Sponsor's protocol ID
- ABx-CVVHDF
- Status last verified
- Jul 2015
- First submitted
- 8 Sep 2014
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drugmonitoring of Antiinfective Drugs in Patients Receiving Continous Veno-venous Hemodiafiltration
- ClinicalTrials.gov ID
- NCT02242721
- Acronym / sponsor ID
- ABx-CVVHDF
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 17 Sep 2014 (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.
Approximately 300 patients have to be enrolled in the study. They are followed up until the end of ICU stay. Usually in clinical routine, patients suspected to have infection and simultaneously renal dysfunction making CVVHDF necessary. After enrolment blood and dialysate specimens are drawn and sent for analysis on specific time points. The analysis results are sent back to the study team at the Charité - Universitätsmedizin Berlin and enable them to optimize antiinfectiva treatment of the study patients.
Data are used to test calculation tools and modify them if necessary.
Detailed description
Little data exist whether desired and necessary blood levels of antiinfective drugs are reached during renal replacement therapy. Drug producing companies are not able to come forward with appropriate dosing recommendation in patients needing renal replacement therapy.
To achieve our study goal we plan:
- To measure serum-concentrations of antiinfective drugs applied to the patients
- To measure concentrations of antiinfective drugs in hemofiltration fluids.
- To compare the actual measured concentrations with concentration predicted in known calculation tools.
- To modify these calculation tools if necessary for better prediction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive care unit patients needing renal replacement therapy | – | –Male and female patients in the intensive care unit (ICU), needing renal replacement therapy due to renal dysfunction and are treated with antiinfective drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critical ill patients
Key inclusion criteria (2 listed)
- Male and female patients, age ≥ 18 years
- Patients in the intensive care unit (ICU), needing renal replacement therapy due to renal dysfunction and are treated with antiinfective drugs
Key exclusion criteria (6 listed)
- Pregnancy and lactation period.
- Participation in a clinical intervention study
- Lacking willingness to save and hand out data within the study
- Accommodation in an institution due to an official or judicial order
- The informed consent of the patient or the subject's legally acceptable representative can´t be obtained in time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Antibiotic clearance (l/h)
Time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
1 secondary outcome
28-day mortality
Time frame: The 28-days mortality will be assessed on the 28th study day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Need for Renal Replacement Therapy and Anti-infective Therapy Due to Severe Infection, run by Charite University, Berlin, Germany at 2 sites 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 6 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: withdrawn, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Antibiotic clearance (l/h) (time frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days). 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 31 Jul 2015; AzTrials last refreshed its copy on 8 Nov 2026.