Critical IllnessNCT02611271
Elimination of Antibiotics During Renal Replacement Therapy and Cytosorb Adsorptive Therapy
An observational study of Critical Illness and Sepsis, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Cytokine adsorption using the cytosorb adsorber is currently investigated to reduce the levels of proinflammatory cytokines in patients with severe sepsis and septic shock. The adsorber is frequently used in series with continuous renal replacement therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Sepsis, Acute Kidney Injury
- What is being tested?
- Monitoring of antibiotic drug removal
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2017to 31 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: Critically ill patients treated for sepsis on surgical intensive care unit undergoing renal replacement therapy.
Who may be able to join
- Intensive care patients with severe sepsis or septic shock and acute kidney injury requiring continuous renal replacement therapy and cytokine adsorption
- Age > 18 y
Who cannot join
- < 18 y
- Pregnancy
- Contraindications against citrate-anticoagulation or continuous renal replacement therapy or cytokine adsorption
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Interdisziplinäre Intensivstation ZOM 1, UKD
Düsseldorf, 40225
Detlef Kindgen-Milles, Prof., 0049 211 81 ext. 07047, Kindgen-Milles@med.uni-duesseldorf.de
About this study
Official title: Elimination of Antibiotics During Combined Continuous Renal Replacement Therapy and Cytosorb Adsorptive Therapy in Patients With Sepsis and Acute Kidney Injury
Cytokine adsorption using the cytosorb adsorber is currently investigated to reduce the levels of proinflammatory cytokines in patients with severe sepsis and septic shock. The adsorber is frequently used in series with continuous renal replacement therapy. Up to date, no data on the removal of antibiotic drugs during combined renal replacement therapy and cytokine adsorptive therapy is available. Therefore, we want to investigate
- whether and to what extent antibiotic drugs (piperacillin/tazobactam and imipenem/cilastatin) are removed during combined continuous renal replacement therapy and cytosorb adsorption in patients with severe sepsis and septic shock
Read the detailed description
Patients in this trial are undergoing renal replacement therapy as part of their routine care. Thus, this is an observational trial.
- Conditions
- Critical Illness, Sepsis, Acute Kidney Injury
- Being tested
- Monitoring of antibiotic drug removal
- Medical subject headings
- Critical Illness, Sepsis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of antibiotic drug removalOther
No study specific intervention will be performed
| Study group | Role | What they receive |
|---|---|---|
| Piperacillin/Tazobactam | Critically ill patients teated with piperacillin/tazobactam undergoing renal replacement therapy and cytosorb absorption during sepsis Receives: Other: Monitoring of antibiotic drug removal | |
| Imipenem/Cilastatin | Critically ill patients teated with imipenem/cilastatin undergoing renal replacement therapy and cytosorb absorption during sepsis Receives: Other: Monitoring of antibiotic drug removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Removal of antibiotic drugs during the first 8 hours of combined continuous renal replacement therapy and cytosorb adsorption
Removal of antibiotic drugs during combined CRRT and adsorption will be evaluated by calculating total filter clearance using the drug concentration pre- and postfilter as well as the dialysate concentration. The adsorptive clearance will be evaluated using the pre- and postadsorber concentration. The outcome measure will be removal of antibiotic drug [mg/8 h dosing interval].
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start1 Dec 2017
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Responsible party
- Principal investigator, Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Detlef Kindgen-Milles, Prof., Principal investigator, Department of Anesthesiology, Duesseldorf University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611271
- Sponsor's protocol ID
- 2015-11-Studienanmeldung
- Status last verified
- May 2020
- First submitted
- 3 Nov 2015
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elimination of Antibiotics During Combined Continuous Renal Replacement Therapy and Cytosorb Adsorptive Therapy in Patients With Sepsis and Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02611271
- Acronym / sponsor ID
- 2015-11-Studienanmeldung
- Conditions
- Critical Illness, Sepsis, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 20 Nov 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.
Cytokine adsorption using the cytosorb adsorber is currently investigated to reduce the levels of proinflammatory cytokines in patients with severe sepsis and septic shock. The adsorber is frequently used in series with continuous renal replacement therapy. Up to date, no data on the removal of antibiotic drugs during combined renal replacement therapy and cytokine adsorptive therapy is available. Therefore, we want to investigate
- whether and to what extent antibiotic drugs (piperacillin/tazobactam and imipenem/cilastatin) are removed during combined continuous renal replacement therapy and cytosorb adsorption in patients with severe sepsis and septic shock
Detailed description
Patients in this trial are undergoing renal replacement therapy as part of their routine care. Thus, this is an observational trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piperacillin/Tazobactam | – | Other: Monitoring of antibiotic drug removalCritically ill patients teated with piperacillin/tazobactam undergoing renal replacement therapy and cytosorb absorption during sepsis |
| Imipenem/Cilastatin | – | Other: Monitoring of antibiotic drug removalCritically ill patients teated with imipenem/cilastatin undergoing renal replacement therapy and cytosorb absorption during sepsis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients treated for sepsis on surgical intensive care unit undergoing renal replacement therapy.
Key inclusion criteria (2 listed)
- Intensive care patients with severe sepsis or septic shock and acute kidney injury requiring continuous renal replacement therapy and cytokine adsorption
- Age > 18 y
Key exclusion criteria (3 listed)
- < 18 y
- Pregnancy
- Contraindications against citrate-anticoagulation or continuous renal replacement therapy or cytokine adsorption
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 |
|---|---|---|
| Monitoring of antibiotic drug removalNo study specific intervention will be performed | Other | Imipenem/Cilastatin, Piperacillin/Tazobactam |
Primary outcome
Removal of antibiotic drugs during the first 8 hours of combined continuous renal replacement therapy and cytosorb adsorption
Time frame: 8 hours
Removal of antibiotic drugs during combined CRRT and adsorption will be evaluated by calculating total filter clearance using the drug concentration pre- and postfilter as well as the dialysate concentration. The adsorptive clearance will be evaluated using the pre- and postadsorber concentration. The outcome measure will be removal of antibiotic drug [mg/8 h dosing interval].
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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. principal investigator
Department of Anesthesiology, Duesseldorf University Hospital
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 Critical Illness and Sepsis, 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 7 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?
Contact Detlef Kindgen-Milles, Prof. (+49 211 81 ext. 07047, Kindgen-Milles@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Removal of antibiotic drugs during the first 8 hours of combined continuous renal replacement therapy and cytosorb adsorption (time frame: 8 hours). 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 7 May 2020.