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Drugmonitoring of Antiinfective Drugs in Patients Receiving Continous Veno-venous Hemodiafiltration (ABx-CVVHDF)

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ClinicalTrials.gov Identifier: NCT02242721
Recruitment Status : Withdrawn
First Posted : September 17, 2014
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany

Brief Summary:

Approximately 300 patients have to be enrolled in the study. They are followed up until the end of ICU stay. Usually in clinical routine, patients suspected to have infection and simultaneously renal dysfunction making CVVHDF necessary. After enrolment blood and dialysate specimens are drawn and sent for analysis on specific time points. The analysis results are sent back to the study team at the Charité - Universitätsmedizin Berlin and enable them to optimize antiinfectiva treatment of the study patients.

Data are used to test calculation tools and modify them if necessary.


Condition or disease
Need for Renal Replacement Therapy and Anti-infective Therapy Due to Severe Infection

Detailed Description:

Little data exist whether desired and necessary blood levels of antiinfective drugs are reached during renal replacement therapy. Drug producing companies are not able to come forward with appropriate dosing recommendation in patients needing renal replacement therapy.

To achieve our study goal we plan:

  1. To measure serum-concentrations of antiinfective drugs applied to the patients
  2. To measure concentrations of antiinfective drugs in hemofiltration fluids.
  3. To compare the actual measured concentrations with concentration predicted in known calculation tools.
  4. To modify these calculation tools if necessary for better prediction.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drugmonitoring of Antiinfective Drugs in Patients Receiving Continous Veno-venous Hemodiafiltration
Study Start Date : October 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : January 2016

Group/Cohort
Intensive care unit patients needing renal replacement therapy
Male and female patients in the intensive care unit (ICU), needing renal replacement therapy due to renal dysfunction and are treated with antiinfective drugs.



Primary Outcome Measures :
  1. Antibiotic clearance (l/h) [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]

Secondary Outcome Measures :
  1. 28-day mortality [ Time Frame: The 28-days mortality will be assessed on the 28th study day ]

Biospecimen Retention:   Samples Without DNA
Blood samples and Dialysate


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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
Critical ill patients
Criteria

Inclusion Criteria:

  • Male and female patients, age ≥ 18 years
  • Patients in the intensive care unit (ICU), needing renal replacement therapy due to renal dysfunction and are treated with antiinfective drugs

Exclusion Criteria:

  • Pregnancy and lactation period.
  • Participation in a clinical intervention study
  • Lacking willingness to save and hand out data within the study
  • Accommodation in an institution due to an official or judicial order
  • The informed consent of the patient or the subject's legally acceptable representative can´t be obtained in time
  • Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial

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): NCT02242721


Locations
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Germany
Medical Department, Division of Nephrology, Campus Charité Mitte, Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Pharmacy, Kliniken Landkreis Heidenheim gGmbH
Heidenheim, Germany, 89522
Sponsors and Collaborators
Charite University, Berlin, Germany

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Responsible Party: Claudia Spies, Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow - Klinikum, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02242721     History of Changes
Other Study ID Numbers: ABx-CVVHDF
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Anti-Infective Agents