Computer-based Dosage Calculation for Antibiotics

Withdrawn

• Conditions: Anti-Infective Agent Toxicity; Acute Kidney Insufficiency
• Interventions: Drug: Piperacillin/tazobactam; Drug: Meropenem

• Registration Number: NCT03036826
• Lead Sponsor: University Hospital Tuebingen

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.

Study Timeline

• Study First Submitted: 2017-01-26
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-30
• Status Verified: 2018-10
• Study Start: 2019-06
• Last Update Submitted: 2019-12-19
• Last Update Posted: 2019-12-24
• Primary Completion: 2021-06
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Piperacillin/Tazobactam	Piperacillin/tazobactam	Group of patients receiving Piperacillin/Tazobactam as antiinfective therapy
Meropenem	Meropenem	Group of patients receiving Meropenem as antiinfective therapy

Primary Outcome Measures

Name	Time	Method
drug levels (blood)	3 days	achieved drug levels in blood samples

Secondary Outcome Measures

Name	Time	Method
dosing changes	3 days	dose adjustments to the computer based calculated regiments

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany