Computer-based Dosage Calculation for Antibiotics

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)

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03036826

Enrollment

Registered

2017-01-30

Start date

2019-06-30

Completion date

2021-12-31

Last updated

2019-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Insufficiency, Anti-Infective Agent Toxicity

Keywords

renal replacement therapy

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.

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.

Interventions

DRUGPiperacillin/tazobactam

antiinfective therapy with Piperacillin/Tazobactam within routine care

DRUGMeropenem

antiinfective therapy with Meropenem within routine care

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
drug levels (blood)	3 days	achieved drug levels in blood samples

Secondary

Measure	Time frame	Description
dosing changes	3 days	dose adjustments to the computer based calculated regiments

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026