Computer-based Dosage Calculation for Antibiotics

Acute Kidney Insufficiency Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03036826
• Other study ID #: CADDy
• Status: Withdrawn
• Start date: June 2019
• Est. completion date: December 2021

Study information

• Verified date: October 2018
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Insufficiency
• Anti-Infective Agent Toxicity
• Renal Insufficiency

Intervention

Drug:
• Piperacillin/tazobactam
antiinfective therapy with Piperacillin/Tazobactam within routine care
• Meropenem
antiinfective therapy with Meropenem within routine care

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	drug levels (blood)	achieved drug levels in blood samples	3 days
Secondary	dosing changes	dose adjustments to the computer based calculated regiments	3 days