NCT03036826

Brief Summary

Adequate dosing of antiinfective therapy in critically ill patients with impaired or lost renal function or continuous renal replacement therapy is nearly impossible without measuring the drug concentration in blood samples. In many hospitals that is still not an option. The investigators aim to show, that computer based calculation can avoid over- or under-dosing.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 26, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
2.3 years until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 24, 2019

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

January 26, 2017

Last Update Submit

December 19, 2019

Conditions

Acute Kidney InsufficiencyAnti-Infective Agent Toxicity

Keywords

renal replacement therapy

Outcome Measures

Primary Outcomes (1)

  • drug levels (blood)

    achieved drug levels in blood samples

    3 days

Secondary Outcomes (1)

  • dosing changes

    3 days

Study Arms (2)

Piperacillin/Tazobactam

Group of patients receiving Piperacillin/Tazobactam as antiinfective therapy

Drug: Piperacillin/tazobactam

Meropenem

Group of patients receiving Meropenem as antiinfective therapy

Drug: Meropenem

Interventions

Piperacillin/tazobactamDRUG

antiinfective therapy with Piperacillin/Tazobactam within routine care

Piperacillin/Tazobactam
MeropenemDRUG

antiinfective therapy with Meropenem within routine care

Meropenem

Eligibility Criteria

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

critically ill patients with impaired renal function and antiinfective therapy

You may qualify if:

  • patients requiring antiinfective therapy
  • patients with impaired renal function or requiring continuous renal replacement therapy

You may not qualify if:

  • plasmapheresis or liver replacement therapy
  • renal replacement therapy with integrated CytoSorb®-Membrane
  • extracorporal live support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Piperacillin, Tazobactam Drug CombinationMeropenem

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TazobactamPenicillanic AcidPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsPiperacillinAmpicillinPenicillin GSulfur CompoundsSulfonesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsThienamycinsCarbapenems

Study Officials

  • Stefanie Prohaska, MD

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2017

First Posted

January 30, 2017

Study Start

June 1, 2019

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

December 24, 2019

Record last verified: 2018-10

Locations

DE(1)