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

NCT ID: NCT01582360

Last Updated: 2015-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

640 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2018-01-31

Brief Summary

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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

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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.

Conditions

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Critically Ill Acute Renal Failure Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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antiinfectiva: vancomycin

80 patients Completed.

No interventions assigned to this group

antiinfectiva: meropenem

80 patients recruiting

No interventions assigned to this group

antiinfectiva: flukonazol

80 patients

No interventions assigned to this group

antiinfectiva: cefotaxim

80 patients

No interventions assigned to this group

antiinfectiva: benzylpenicilline

80 patients

No interventions assigned to this group

antiinfectiva: tazobactam piperacillin

80 patients recruiting

No interventions assigned to this group

antiinfectiva: cloxacillin

80 patients

No interventions assigned to this group

antiinfectiva: ciprofloxacin

80 patients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elin Helset, MD PhD

Role: STUDY_CHAIR

Oslo University Hospital

Jan Fr Bugge, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Elizabeth von der Lippe, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Hilde Ma Sporsem, cand pharm

Role: PRINCIPAL_INVESTIGATOR

Sykehusapotekene Oslo

Yvonne Lao, cand pharm

Role: PRINCIPAL_INVESTIGATOR

Sykehusapotekene Oslo

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Elin Helset, MD PhD

Role: CONTACT

+4722119585

Other Identifiers

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2011/10076 (OUSH)

Identifier Type: OTHER

Identifier Source: secondary_id

2011/10076

Identifier Type: -

Identifier Source: org_study_id

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