Acute Kidney InsufficiencyNCT03036826
Computer-based Dosage Calculation for Antibiotics
An observational study of Acute Kidney Insufficiency and Anti-Infective Agent Toxicity, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Adequate dosing of antiinfective therapy in critically ill patients with impaired or lost renal function or continuous renal replacement therapy is nearly impossible without measuring the drug concentration in blood samples. In many hospitals that is still not an option. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Insufficiency, Anti-Infective Agent Toxicity
- What is being tested?
- Piperacillin/tazobactam and Meropenem
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2019to Dec 2021
- 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: critically ill patients with impaired renal function and antiinfective therapy
Who may be able to join
- patients requiring antiinfective therapy
- patients with impaired renal function or requiring continuous renal replacement therapy
Who cannot join
- plasmapheresis or liver replacement therapy
- renal replacement therapy with integrated CytoSorb®-Membrane
- extracorporal live support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computer-basierte Dosierungsregime Von Antiinfektiva Bei eingeschränkter Nierenfunktion Und Kontinuierlichen Nierenersatztherapieverfahren (Computer-based Dosage Calculation for Antibiotics in Patients With Impaired Renal Function or Renal Replacement Therapy)
Adequate dosing of antiinfective therapy in critically ill patients with impaired or lost renal function or continuous renal replacement therapy is nearly impossible without measuring the drug concentration in blood samples. In many hospitals that is still not an option. The investigators aim to show, that computer based calculation can avoid over- or under-dosing.
Read the detailed description
Adequate dosing of antiinfective therapy in critically ill patients is most important to improve outcome. Patients with impaired or lost renal function or continuous renal replacement therapy are hard to calculate using drug information sheets or "lists" with recommendations. It is nearly impossible to avoid drug levels that are much to low or much to high without measuring the concentration in blood samples. Since that possibility is still not available in every clinic we aim to show, how a computer based calculation can help to find the adequate dosing.
- Being tested
- Piperacillin/tazobactam, Meropenem
- Keywords
- renal replacement therapy
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin/tazobactamDrug
antiinfective therapy with Piperacillin/Tazobactam within routine care
MeropenemDrug
antiinfective therapy with Meropenem within routine care
| Study group | Role | What they receive |
|---|---|---|
| Piperacillin/Tazobactam | Group of patients receiving Piperacillin/Tazobactam as antiinfective therapy Receives: Drug: Piperacillin/tazobactam | |
| Meropenem | Group of patients receiving Meropenem as antiinfective therapy Receives: Drug: Meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
drug levels (blood)
achieved drug levels in blood samples
Measured: 3 days
Secondary outcomes (1)
dosing changes
dose adjustments to the computer based calculated regiments
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startJun 2019 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: due to organisational changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InsufficiencyStudies of the same condition, open and under way.
- 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
- 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
- NCT03036826
- Sponsor's protocol ID
- CADDy
- Status last verified
- Oct 2018
- First submitted
- 26 Jan 2017
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-basierte Dosierungsregime Von Antiinfektiva Bei eingeschränkter Nierenfunktion Und Kontinuierlichen Nierenersatztherapieverfahren (Computer-based Dosage Calculation for Antibiotics in Patients With Impaired Renal Function or Renal Replacement Therapy)
- ClinicalTrials.gov ID
- NCT03036826
- Acronym / sponsor ID
- CADDy
- Keywords
- renal replacement therapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: due to organisational changes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 30 Jan 2017 (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.
Adequate dosing of antiinfective therapy in critically ill patients with impaired or lost renal function or continuous renal replacement therapy is nearly impossible without measuring the drug concentration in blood samples. In many hospitals that is still not an option. The investigators aim to show, that computer based calculation can avoid over- or under-dosing.
Detailed description
Adequate dosing of antiinfective therapy in critically ill patients is most important to improve outcome. Patients with impaired or lost renal function or continuous renal replacement therapy are hard to calculate using drug information sheets or "lists" with recommendations. It is nearly impossible to avoid drug levels that are much to low or much to high without measuring the concentration in blood samples. Since that possibility is still not available in every clinic we aim to show, how a computer based calculation can help to find the adequate dosing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piperacillin/Tazobactam | – | Drug: Piperacillin/tazobactamGroup of patients receiving Piperacillin/Tazobactam as antiinfective therapy |
| Meropenem | – | Drug: MeropenemGroup of patients receiving Meropenem as antiinfective therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill patients with impaired renal function and antiinfective therapy
Key inclusion criteria (2 listed)
- patients requiring antiinfective therapy
- patients with impaired renal function or requiring continuous renal replacement therapy
Key exclusion criteria (3 listed)
- plasmapheresis or liver replacement therapy
- renal replacement therapy with integrated CytoSorb®-Membrane
- extracorporal live support
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 |
|---|---|---|
| Piperacillin/tazobactamantiinfective therapy with Piperacillin/Tazobactam within routine care | Drug | Piperacillin/Tazobactam |
| Meropenemantiinfective therapy with Meropenem within routine care | Drug | Meropenem |
Primary outcome
drug levels (blood)
Time frame: 3 days
achieved drug levels in blood samples
1 secondary outcome
dosing changes
Time frame: 3 days
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 24 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 Acute Kidney Insufficiency and Anti-Infective Agent Toxicity, 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 2 inclusion and 3 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 24 Dec 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 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?
drug levels (blood) (time frame: 3 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 24 Dec 2019.