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Computer-based Dosage Calculation for Antibiotics

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ClinicalTrials.gov Identifier: NCT03036826
Recruitment Status : Not yet recruiting
First Posted : January 30, 2017
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Acute Kidney Insufficiency Anti-Infective Agent Toxicity Drug: Piperacillin/tazobactam Drug: Meropenem

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. drug levels (blood) [ Time Frame: 3 days ]
    achieved drug levels in blood samples


Secondary Outcome Measures :
  1. dosing changes [ Time Frame: 3 days ]
    dose adjustments to the computer based calculated regiments


Biospecimen Retention:   Samples With DNA
blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
critically ill patients with impaired renal function and antiinfective therapy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036826


Contacts
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Contact: Stefanie Prohaska, MD +49707129 ext 68029 stefanie.prohaska@med.uni-tuebingen.de
Contact: Helene A Haeberle, MD +49707129 ext 86939

Locations
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Germany
University Hospital Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Stefanie Prohaska, MD University Hospital Tuebingen

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03036826     History of Changes
Other Study ID Numbers: CADDy
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital Tuebingen:
renal replacement therapy

Additional relevant MeSH terms:
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Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Anti-Bacterial Agents
Meropenem
Tazobactam
Piperacillin
Piperacillin, Tazobactam Drug Combination
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action