2012_PharmacoCRRT-study:Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT)
PharmacoCRRT
Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT) or Without CRRT
2 other identifiers
observational
640
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2012
CompletedFirst Posted
Study publicly available on registry
April 20, 2012
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedOctober 16, 2015
October 1, 2015
3.7 years
April 19, 2012
October 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sub-therapeutic levels of measured antiinfectiva
Pharmacokinetic/pharmacodynamic index achieved for each antiinfectiva
72 hours
Secondary Outcomes (2)
SOFA-score
72 hrs
Mortality
90-days
Study Arms (8)
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
Eligibility Criteria
Critically ill patients admitted to the ICU at Oslo University Hospital, in need of treatment with antiinfectives.
You may qualify if:
- 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
You may not qualify if:
- Acute or chronic renal failure not in need of CRRT
- Age \< 18 yrs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo University Hospital
Oslo, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Elin Helset, MD PhD
Oslo University Hospital
- PRINCIPAL INVESTIGATOR
Jan Fr Bugge, MD PhD
Oslo University Hospital
- PRINCIPAL INVESTIGATOR
Elizabeth von der Lippe, MD PhD
Oslo University Hospital
- PRINCIPAL INVESTIGATOR
Hilde Ma Sporsem, cand pharm
Sykehusapotekene Oslo
- PRINCIPAL INVESTIGATOR
Yvonne Lao, cand pharm
Sykehusapotekene Oslo
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2012
First Posted
April 20, 2012
Study Start
May 1, 2013
Primary Completion
January 1, 2017
Study Completion
January 1, 2018
Last Updated
October 16, 2015
Record last verified: 2015-10