Computer-based Dosage Calculation for Antibiotics

December 19, 2019 updated by: University Hospital Tuebingen

Computer-basierte Dosierungsregime Von Antiinfektiva Bei eingeschränkter Nierenfunktion Und Kontinuierlichen Nierenersatztherapieverfahren (Computer-based Dosage Calculation for Antibiotics in Patients With Impaired Renal Function or Renal Replacement Therapy)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Adequate dosing of antiinfective therapy in critically ill patients is most important to improve outcome. Patients with impaired or lost renal function or continuous renal replacement therapy are hard to calculate using drug information sheets or "lists" with recommendations. It is nearly impossible to avoid drug levels that are much to low or much to high without measuring the concentration in blood samples. Since that possibility is still not available in every clinic we aim to show, how a computer based calculation can help to find the adequate dosing.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • University Hospital Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 with impaired renal function and antiinfective therapy

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Piperacillin/Tazobactam
Group of patients receiving Piperacillin/Tazobactam as antiinfective therapy
Drug: Piperacillin/tazobactam
antiinfective therapy with Piperacillin/Tazobactam within routine care
Meropenem
Group of patients receiving Meropenem as antiinfective therapy
Drug: Meropenem
antiinfective therapy with Meropenem within routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
drug levels (blood)
Time Frame: 3 days
achieved drug levels in blood samples
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dosing changes
Time Frame: 3 days
dose adjustments to the computer based calculated regiments
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Stefanie Prohaska, MD, University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

January 27, 2017

First Posted (Estimate)

January 30, 2017

Study Record Updates

Last Update Posted (Actual)

December 24, 2019

Last Update Submitted That Met QC Criteria

December 19, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CADDy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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