NCT04203784

Brief Summary

This observational study reports meropenem and piperacillin plasma concentrations in patients treated with either antibiotic and simultaneous continuous renal replacement therapy (CRRT).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
Last Updated

December 19, 2019

Status Verified

December 1, 2019

Enrollment Period

4.2 years

First QC Date

November 3, 2019

Last Update Submit

December 17, 2019

Conditions

SepsisInfectionAntibioticRenal Replacement TherapyHemolysis

Outcome Measures

Primary Outcomes (4)

  • Plasma antibiotic concentrations at mid and end of dosing interval

    We vill report the measured plasma antibiotic concentrations at the mid and end of the dosing interval.

    1 week

  • Plasma antibiotic concentrations at mid and end of dosing interval

    The percentage of patients having a concentration above the highest MIC (minimal inhibitory concentration) breakpoint for pathogens considered susceptible for the antibiotic.

    1 week

  • Relationships between plasma antibiotic concentrations and CRRT dose.

    We will report the correlation between measured plasma concentrations of either antibiotic and the intensity of the CRRT treatment.

    1 week

  • Influence of residual diuresis on the measured plasma antibiotic concentrations.

    We will report the correlation between measured plasma concentrations of either antibiotic and residual diuresis.

    1 week

Study Arms (2)

Meropenem treated patients

Other: Plasma concentration measurements

Piperacillin treated patients

Other: Plasma concentration measurements

Interventions

Plasma concentration measurementsOTHER

Plasma concentration measurements

Meropenem treated patientsPiperacillin treated patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patients

You may qualify if:

  • patients treated in the study ICU and
  • simultaneous CRRT and antibiotic treatment with either meropenem or piperacillin-tazobactam.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital Solna

Stockholm, 17176, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

SepsisInfectionsHemolysis

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior ICU Consultant

Study Record Dates

First Submitted

November 3, 2019

First Posted

December 18, 2019

Study Start

November 1, 2012

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

December 19, 2019

Record last verified: 2019-12

Locations

SE(1)