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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01582360
First received: April 19, 2012
Last updated: October 22, 2014
Last verified: October 2014
  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 /Antibiotics in Critically Ill Patients in Need of Continuous Renal Replacement Therapy (CRRT) or Without CRRT

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

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


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

  • Mortality [ Time Frame: 90-days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 640
Study Start Date: May 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
antiinfectiva: vancomycin
80 patients
antiinfectiva: meropenem
80 patients
antiinfectiva: flukonazol
80 patients
antiinfectiva: cefotaxim
80 patients
antiinfectiva: benzylpenicilline
80 patients
antiinfectiva: tazobactam piperacillin
80 patients
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01582360     History of Changes
Other Study ID Numbers: 2011/10076, 2011/10076 (OUSH)
Study First Received: April 19, 2012
Last Updated: October 22, 2014
Health Authority: Norway: Data Protection Authority

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:
Acute Kidney Injury
Critical Illness
Renal Insufficiency
Disease Attributes
Kidney Diseases
Pathologic Processes
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014