Monitoring of Piperacillin-Tazobactam and Meropenem Plasmatic Levels in Critical Patients
NCT ID: NCT04257838
Last Updated: 2020-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2020-02-15
2021-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Piperacillin-Tazobactam or Meropenem Cohort
Patients hospitalized for sepsis or septic shock that are treated with Piperacillin-Tazobactam or Meropenem and meet all the inclusion criteria and none of the exclusion criteria.
Piperacillin/tazobactam or Meropenem
The plasmatic levels determinations will always be made in state of equilibrium (after the fourth dose) and two samples will be collected:
1. Just before the antibiotic infusion (T0)
2. In the midpoint of time (T50). If the antibiotic is administered every 8 hours this determination will be made at 4 hours. If the antibiotic is administered every 6 hours, the determination will be made at 3 hours.
A second complete determination will be made (before the infusion, in the midpoint of time and before the next dose) after the administration of 4 doses as long as a posology modification is made as a consequence of the information received from the plasmatic levels.
Interventions
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Piperacillin/tazobactam or Meropenem
The plasmatic levels determinations will always be made in state of equilibrium (after the fourth dose) and two samples will be collected:
1. Just before the antibiotic infusion (T0)
2. In the midpoint of time (T50). If the antibiotic is administered every 8 hours this determination will be made at 4 hours. If the antibiotic is administered every 6 hours, the determination will be made at 3 hours.
A second complete determination will be made (before the infusion, in the midpoint of time and before the next dose) after the administration of 4 doses as long as a posology modification is made as a consequence of the information received from the plasmatic levels.
Eligibility Criteria
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Inclusion Criteria
* Hospitalized in the Intense Care Unit.
* Patients treated with Piperacillin-Tazobactam or Meropenem.
* Septic shock.
* Renal hyper clearance.
* Gram-negative bacillary bacteremia.
* Continuous renal replacement technique.
* ECMO.
* Obesity (BMI\> 40).
Exclusion Criteria
* Pregnant women.
18 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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José Garnacho Montero
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen Macarena
Locations
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Hospital Universitario Virgen Macarena
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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Marta María Pinilla de Torre
Role: primary
Other Identifiers
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FIS-MER-2019-01
Identifier Type: -
Identifier Source: org_study_id
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