Critically IllPharmacoCRRTNCT01582360
2012_PharmacoCRRT-study:Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT)
An observational study of Critically Ill and Acute Renal Failure, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The main purpose of the study is to examine if changes in pharmacokinetics of important antiinfectives in Critically Ill patients in need of continuous renal replacement therapy (CRRT), causes inadequate concentrations in plasma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Acute Renal Failure, Acute Kidney Injury
- How many people
- 640 participants
- Where
- 1 siteNorway
- Study dates
- May 2013to Jan 2018
- 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 admitted to the ICU at Oslo University Hospital, in need of treatment with antiinfectives.
Who may be able to join
- Patients admitted to ICU in need of antiinfectives:
- in need of CRRT
- without acute kidney failure
- requirement for antiinfectives> 72 hrs
- Age > 18 yrs
- signed informed consent
Who cannot join
- Acute or chronic renal failure not in need of CRRT
- Age < 18 yrs
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo
Elin Helset, MD PhD
Jan Fr Bugge, MD PhD
About this study
Official title: Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT) or Without CRRT
The main purpose of the study is to examine if changes in pharmacokinetics of important antiinfectives in Critically Ill patients in need of continuous renal replacement therapy (CRRT), causes inadequate concentrations in plasma.
The effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of filter, filter lifetime etc.
Hypothesis: The risk of incorrect dosage of antiinfectives - to low/ to high- is increased in critically ill patients receiving CRRT. Inadequate plasma concentrations of antiinfectives may contribute to increased mortality in this group.
Read the detailed description
The main purpose of the study is to examine if changes in pharmacokinetics of important antiinfectives in Critically Ill patients in need of continuous renal replacement therapy (CRRT), causes inadequate concentrations in plasma.
The effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of filter, filter lifetime etc.
Hypothesis: The risk of incorrect dosage of antiinfectives - to low/ to high- is increased in critically ill patients receiving CRRT. Inadequate plasma concentrations of antiinfectives may contribute to increased mortality in this group.
The antiinfectives to be examined are meropenem, fluconazol, cefotaxim, ciprofloxacin, tazobactam-piperacillin, vancomycin,penicillin,cloxacillin.
Endpoints:
- Measured plasma concentrations of antiinfectives are sufficient for maximal microbial killing.
- To identify the most important variability factors for plasma concentrations of antiinfectives in patients receiving CRRT
- Establish and validate a routine for measurement of vital antiinfectives.
- Conditions
- Critically Ill, Acute Renal Failure, Acute Kidney Injury
- Keywords
- critical illness, pharmacokinetics, CRRT, CVVH, CVVHD, CVVHDF, antiinfectives, antibiotics, minimum inhibitory concentration, bacterial killing, pharmacodynamics, PK/PD index
- Medical subject headings
- Critical Illness, Acute Kidney Injury
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 |
|---|---|---|
| antiinfectiva: vancomycin | 80 patients Completed. | |
| antiinfectiva: meropenem | 80 patients recruiting | |
| antiinfectiva: flukonazol | 80 patients | |
| antiinfectiva: cefotaxim | 80 patients | |
| antiinfectiva: benzylpenicilline | 80 patients | |
| antiinfectiva: tazobactam piperacillin | 80 patients recruiting | |
| antiinfectiva: cloxacillin | 80 patients | |
| antiinfectiva: ciprofloxacin | 80 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sub-therapeutic levels of measured antiinfectiva
Pharmacokinetic/pharmacodynamic index achieved for each antiinfectiva
Measured: 72 hours
Secondary outcomes (2)
SOFA-score
Sequential organ failure assessment, first 3 days after initiation of therapy
Measured: 72 hrs
Mortality
Measured: 90-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startMay 2013
- Primary completionJan 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elin Helset, MD PhD, Study chair, Oslo University HospitalJan Fr Bugge, MD PhD, Principal investigator, Oslo University HospitalElizabeth von der Lippe, MD PhD, Principal investigator, Oslo University HospitalHilde Ma Sporsem, cand pharm, Principal investigator, Sykehusapotekene OsloYvonne Lao, cand pharm, Principal investigator, Sykehusapotekene Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582360
- Sponsor's protocol ID
- 2011/10076
- Other IDs
- 2011/10076 (OUSH)
- Acronym
- PharmacoCRRT
- Status last verified
- Oct 2015
- First submitted
- 19 Apr 2012
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT) or Without CRRT
- ClinicalTrials.gov ID
- NCT01582360
- Acronym / sponsor ID
- PharmacoCRRT / 2011/10076
- Conditions
- Critically Ill, Acute Renal Failure, Acute Kidney Injury
- Keywords
- critical illness, pharmacokinetics, CRRT, CVVH, CVVHD, CVVHDF, antiinfectives, antibiotics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 20 Apr 2012 (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.
The main purpose of the study is to examine if changes in pharmacokinetics of important antiinfectives in Critically Ill patients in need of continuous renal replacement therapy (CRRT), causes inadequate concentrations in plasma.
The effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of filter, filter lifetime etc.
Hypothesis: The risk of incorrect dosage of antiinfectives - to low/ to high- is increased in critically ill patients receiving CRRT. Inadequate plasma concentrations of antiinfectives may contribute to increased mortality in this group.
Detailed description
The main purpose of the study is to examine if changes in pharmacokinetics of important antiinfectives in Critically Ill patients in need of continuous renal replacement therapy (CRRT), causes inadequate concentrations in plasma.
The effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of filter, filter lifetime etc.
Hypothesis: The risk of incorrect dosage of antiinfectives - to low/ to high- is increased in critically ill patients receiving CRRT. Inadequate plasma concentrations of antiinfectives may contribute to increased mortality in this group.
The antiinfectives to be examined are meropenem, fluconazol, cefotaxim, ciprofloxacin, tazobactam-piperacillin, vancomycin,penicillin,cloxacillin.
Endpoints:
- Measured plasma concentrations of antiinfectives are sufficient for maximal microbial killing.
- To identify the most important variability factors for plasma concentrations of antiinfectives in patients receiving CRRT
- Establish and validate a routine for measurement of vital antiinfectives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| antiinfectiva: vancomycin | – | –80 patients Completed. |
| antiinfectiva: meropenem | – | –80 patients recruiting |
| antiinfectiva: flukonazol | – | –80 patients |
| antiinfectiva: cefotaxim | – | –80 patients |
| antiinfectiva: benzylpenicilline | – | –80 patients |
| antiinfectiva: tazobactam piperacillin | – | –80 patients recruiting |
| antiinfectiva: cloxacillin | – | –80 patients |
| antiinfectiva: ciprofloxacin | – | –80 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted to the ICU at Oslo University Hospital, in need of treatment with antiinfectives.
Key inclusion criteria (6 listed)
- Patients admitted to ICU in need of antiinfectives:
- requirement for antiinfectives> 72 hrs
- Age > 18 yrs
- signed informed consent
Key exclusion criteria (2 listed)
- Acute or chronic renal failure not in need of CRRT
- Age < 18 yrs
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
Sub-therapeutic levels of measured antiinfectiva
Time frame: 72 hours
Pharmacokinetic/pharmacodynamic index achieved for each antiinfectiva
2 secondary outcomes
SOFA-score
Time frame: 72 hrs
Mortality
Time frame: 90-days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
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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.
Elin Helset, MD PhD study chair
Oslo University Hospital
Jan Fr Bugge, MD PhD principal investigator
Oslo University Hospital
Elizabeth von der Lippe, MD PhD principal investigator
Oslo 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 Critically Ill and Acute Renal Failure, run by Oslo University Hospital at 1 site in Norway.
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 6 inclusion and 2 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 16 Oct 2015. 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 Norway. 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 Elin Helset, MD PhD (+4722119585, ehj@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sub-therapeutic levels of measured antiinfectiva (time frame: 72 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 16 Oct 2015.