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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Kidney Injury; Acute Renal Failure; Critically Ill

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.

• Study Type: Observational
• Enrollment (Anticipated): 640

Contacts and Locations

• Study Contact: Name: Elin Helset, MD PhD; Phone Number: +4722119585; Email: ehj@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: April 19, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Estimate): October 16, 2015
• Last Update Submitted That Met QC Criteria: October 14, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: pharmacokinetics; pharmacodynamics; antibiotics; critical illness; CRRT; CVVHDF; antiinfectives; CVVHD; CVVH; minimum inhibitory concentration; bacterial killing; PK/PD index
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Critical Illness; Acute Kidney Injury
• Other Study ID Numbers: 2011/10076; 2011/10076 (OUSH) (Other Identifier: 2011/10076 (Oslo University Hospital))