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2012_PharmacoCRRT-study:Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT) (PharmacoCRRT)

This study is currently recruiting participants.
Verified October 2015 by Oslo University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01582360
First Posted: April 20, 2012
Last Update Posted: October 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Oslo University Hospital
  Purpose

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.


Condition
Critically Ill Acute Renal Failure Acute Kidney Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics of Anti-infectives in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT) or Without CRRT

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Sub-therapeutic levels of measured antiinfectiva [ Time Frame: 72 hours ]
    Pharmacokinetic/pharmacodynamic index achieved for each antiinfectiva


Secondary Outcome Measures:
  • SOFA-score [ Time Frame: 72 hrs ]
    Sequential organ failure assessment, first 3 days after initiation of therapy

  • Mortality [ Time Frame: 90-days ]

Estimated Enrollment: 640
Study Start Date: May 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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:

  1. Measured plasma concentrations of antiinfectives are sufficient for maximal microbial killing.
  2. To identify the most important variability factors for plasma concentrations of antiinfectives in patients receiving CRRT
  3. Establish and validate a routine for measurement of vital antiinfectives.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients admitted to the ICU at Oslo University Hospital, in need of treatment with antiinfectives.
Criteria

Inclusion Criteria:

  1. Patients admitted to ICU in need of antiinfectives:

    1. in need of CRRT
    2. without acute kidney failure
  2. requirement for antiinfectives> 72 hrs
  3. Age > 18 yrs
  4. signed informed consent

Exclusion Criteria:

  1. Acute or chronic renal failure not in need of CRRT
  2. Age < 18 yrs
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582360


Contacts
Contact: Elin Helset, MD PhD +4722119585 ehj@ous-hf.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Principal Investigator: Elin Helset, MD PhD         
Principal Investigator: Jan Fr Bugge, MD PhD         
Principal Investigator: Hilde Ma Sporsem, cand pharm         
Principal Investigator: Yvonne Lao, cand pharm         
Principal Investigator: Kirsti Andersson, MD         
Sponsors and Collaborators
Oslo University Hospital
Investigators
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
  More Information

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01582360     History of Changes
Other Study ID Numbers: 2011/10076
2011/10076 (OUSH) ( Other Identifier: 2011/10076 (Oslo University Hospital) )
First Submitted: April 19, 2012
First Posted: April 20, 2012
Last Update Posted: October 16, 2015
Last Verified: October 2015

Keywords provided by Oslo University Hospital:
critical illness
pharmacokinetics
CRRT
CVVH
CVVHD
CVVHDF
antiinfectives
antibiotics
minimum inhibitory concentration
bacterial killing
pharmacodynamics
PK/PD index

Additional relevant MeSH terms:
Critical Illness
Renal Insufficiency
Acute Kidney Injury
Disease Attributes
Pathologic Processes
Kidney Diseases
Urologic Diseases
Anti-Infective Agents