Meropenem and Piperacillin Plasma Concentrations During CRRT (ABC2)

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

Study Overview

• Status: Completed
• Conditions: Sepsis; Hemolysis; Renal Replacement Therapy; Infection; Antibiotic
• Intervention / Treatment: Other: Plasma concentration measurements

• Study Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Karolinska University Hospital Solna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ICU patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Meropenem treated patients	Other: Plasma concentration measurements; Plasma concentration measurements
Piperacillin treated patients	Other: Plasma concentration measurements; Plasma concentration measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: November 3, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 19, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemolysis
• Other Study ID Numbers: K 2019-9604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No