Acute Kidney InjuryDIADSORBMABNCT02533609
Elimination of Antibiotics During Citrate-anticoagulated Continuous-veno-venous-haemodialysis
An observational study of Acute Kidney Injury and Bacterial Infection, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Acute kidney injury (AKI) requiring renal replacement therapy is common in critically ill patients. The major causes of AKI are severe sepsis and septic shock requiring effective antibiotic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Bacterial Infection
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Dec 2020
- 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: Intensive care patients with acute kidney injury requiring continous renal replacement therapy with citrate-anticoagulation
Who may be able to join
- Intensive care patients with acute kidney injury requiring continous renal replacement therapy with citrate-anticoagulation
- Age > 18 y
Who cannot join
- < 18 y
- Pregnancy
- Contraindications against citrate-anticoagulation or continous renal replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
Acute kidney injury (AKI) requiring renal replacement therapy is common in critically ill patients. The major causes of AKI are severe sepsis and septic shock requiring effective antibiotic treatment. Patients with sepsis on ICUs usually are haemodynamically instable so that renal replacement therapy is applied using continuous techniques. In recent years, the efficacy of renal replacement therapies has improved, namely by using regional citrate anticoagulation which improves filter lifetime and filter patency. At present, the extent of removal of antibiotic drugs using citrate-anticoagulated CVVHD in critically ill patients has not been investigated thoroughly. Thus, the investigators want to investigate
- whether and to what extent antibiotic drugs (piperacillin/tazobactam and imipenem/cilastatin) are removed during citrate-anticoagulated CVVHD per se
- whether filter patency during citrate-anticoagulated CVVD remains stable during a treatment period of 72 h
- Conditions
- Acute Kidney Injury, Bacterial Infection
- Medical subject headings
- Acute Kidney Injury, Bacterial Infections
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 |
|---|---|---|
| Piperacillin/Tazobactam | Patients undergoing continuous veno-venous renal replacement therapy and treated with this antibiotics | |
| Imipenem/Cilastatin | Patients undergoing continuous veno-venous renal replacement therapy and treated with this antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Removal of antibiotic drugs during day 1 - 2 - 3 of citrate anticoagulated CVVHD (mg/d)
Total hemofilter clearance (ml/min) of imipenem/cilastatin and piperacillin/tazobactam on each treatment day during an 8-hour dosing interval using blood sided clearance
- Total amount of antibiotic drug which is eliminated via the filter during 24 h using filter clearance and delivered dialysis dose during 24 h
Measured: up to three days
Filter patency during day 1 - 2 - 3 of citrate anticoagulated CVVHD
Filter patency is calculated as a function of the sieving coefficient for small solutes (i.e. creatinine and the respective antibiotic drugs) over the first 72 h, Sieving coefficient is without dimension
Measured: up to three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Medical Care Deutschland GmbH
- Responsible party
- Principal investigator, Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Detlef Kindgen-Milles, Prof., Study director, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533609
- Sponsor's protocol ID
- 2015-02-ENDVERSION
- Acronym
- DIADSORBMAB
- Status last verified
- May 2020
- First submitted
- 20 Aug 2015
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elimination of Antibiotics During Citrate-anticoagulated Continuous-veno-venous-haemodialysis
- ClinicalTrials.gov ID
- NCT02533609
- Acronym / sponsor ID
- DIADSORBMAB / 2015-02-ENDVERSION
- Conditions
- Acute Kidney Injury, Bacterial Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- Fresenius Medical Care Deutschland GmbH
- Study start
- Sep 2015
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 27 Aug 2015 (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.
Acute kidney injury (AKI) requiring renal replacement therapy is common in critically ill patients. The major causes of AKI are severe sepsis and septic shock requiring effective antibiotic treatment. Patients with sepsis on ICUs usually are haemodynamically instable so that renal replacement therapy is applied using continuous techniques. In recent years, the efficacy of renal replacement therapies has improved, namely by using regional citrate anticoagulation which improves filter lifetime and filter patency. At present, the extent of removal of antibiotic drugs using citrate-anticoagulated CVVHD in critically ill patients has not been investigated thoroughly. Thus, the investigators want to investigate
- whether and to what extent antibiotic drugs (piperacillin/tazobactam and imipenem/cilastatin) are removed during citrate-anticoagulated CVVHD per se
- whether filter patency during citrate-anticoagulated CVVD remains stable during a treatment period of 72 h
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piperacillin/Tazobactam | – | –Patients undergoing continuous veno-venous renal replacement therapy and treated with this antibiotics |
| Imipenem/Cilastatin | – | –Patients undergoing continuous veno-venous renal replacement therapy and treated with this antibiotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care patients with acute kidney injury requiring continous renal replacement therapy with citrate-anticoagulation
Key inclusion criteria (2 listed)
- Intensive care patients with acute kidney injury requiring continous renal replacement therapy with citrate-anticoagulation
- Age > 18 y
Key exclusion criteria (3 listed)
- < 18 y
- Pregnancy
- Contraindications against citrate-anticoagulation or continous renal replacement therapy
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
Removal of antibiotic drugs during day 1 - 2 - 3 of citrate anticoagulated CVVHD (mg/d)
Time frame: up to three days
Total hemofilter clearance (ml/min) of imipenem/cilastatin and piperacillin/tazobactam on each treatment day during an 8-hour dosing interval using blood sided clearance - Total amount of antibiotic drug which is eliminated via the filter during 24 h using filter clearance and delivered dialysis dose during 24 h
Filter patency during day 1 - 2 - 3 of citrate anticoagulated CVVHD
Time frame: up to three days
Filter patency is calculated as a function of the sieving coefficient for small solutes (i.e. creatinine and the respective antibiotic drugs) over the first 72 h, Sieving coefficient is without dimension
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
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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.
Detlef Kindgen-Milles, Prof. study director
Department of Anesthesiology
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 Injury and Bacterial Infection, run by Heinrich-Heine University, Duesseldorf 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: status not confirmed, as of the sponsor's last update on 11 May 2020. 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?
Results are not available in the source record.
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?
Removal of antibiotic drugs during day 1 - 2 - 3 of citrate anticoagulated CVVHD (mg/d) (time frame: up to three 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 11 May 2020.