2012_PharmacoCRRT-study:Pharmacokinetics of Anti-infectiv... | NCT01582360

ID	Type	Description	Link
2011/10076 (OUSH)	Other Identifier	2011/10076 (Oslo University Hospital)

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Jan 2017Estimated

Completion Date

Jan 2018Estimated

First Submitted Date

Apr 19, 2012

First Submission Date that Met QC Criteria

Apr 19, 2012

First Posted Date

Apr 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2015

Last Update Posted Date

Oct 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The effect of different modus of CRRT: CVVH and CVVHD will be compared, as well as type of filter, filter lifetime etc.

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 Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

640Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sub-therapeutic levels of measured antiinfectiva	Pharmacokinetic/pharmacodynamic index achieved for each antiinfectiva	72 hours

Secondary Outcomes

Measure	Description	Time Frame
SOFA-score	Sequential organ failure assessment, first 3 days after initiation of therapy	72 hrs
Mortality		90-days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted to ICU in need of antiinfectives:
1. in need of CRRT
2. without acute kidney failure
requirement for antiinfectives> 72 hrs
Age > 18 yrs
signed informed consent

Exclusion Criteria:

Acute or chronic renal failure not in need of CRRT
Age < 18 yrs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Critically ill patients admitted to the ICU at Oslo University Hospital, in need of treatment with antiinfectives.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elin Helset, MD PhD	Contact	+4722119585		ehj@ous-hf.no

Overall Officials

Name	Affiliation	Role
Elin Helset, MD PhD	Oslo University Hospital	Study Chair
Jan Fr Bugge, MD PhD	Oslo University Hospital	Principal Investigator
Elizabeth von der Lippe, MD PhD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital	Recruiting	Oslo			Norway

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D016638	Critical Illness
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases