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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 June 2016 |
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Main ID: |
NCT02294695 |
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Date of registration:
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07/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Early Procalcitonin Kinetics During Empirical Antibiotic Therapy in Critically Ill Patients
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Scientific title:
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Early Procalcitonin Kinetics May Indicate Effectiveness of the Empirical Antibiotic Therapy in Sepsis Within Hours |
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Date of first enrolment:
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October 2012 |
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Target sample size:
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209 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02294695 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Hungary
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical signs of infection
- Suspected or proven acute infection requiring empiric antibiotic therapy as decided
by the attending ICU physician
- Suspected site of infection has to be present and documented
- Microbiological sample sent for staining
- Inflammatory markers available at the start of the therapy
Exclusion Criteria:
- Patients younger than 18 years
- Who received prophylactic or empiric antibiotic therapy 48 hours before inclusion
- Whose receiving acute renal replacement therapy in the first 24 hours following
antibiotic treatment
- Following cardiopulmonary resuscitation
- End stage diseases with a "do not resuscitate" order
- Immunocompromised patients (human immunodeficiency virus infection, bone marrow
transplantation, malignant haematological disorders and chemotherapy)
- Post cardiac surgery patients
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bacterial Infections
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Primary Outcome(s)
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Procalcitonin kinetic
[Time Frame: The first six days after starting empiric antibiotic treatment]
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Secondary Outcome(s)
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Sequential Organ Failure Assessment score
[Time Frame: The first six days after starting empiric antibiotic treatment]
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Secondary ID(s)
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EProK study
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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