Monitoring of Piperacillin-Tazobactam and Meropenem Plasmatic Levels in Critical Patients

NCT ID: NCT04257838

Last Updated: 2020-02-06

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-15

Study Completion Date

2021-03-15

Brief Summary

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The aim of this study is to establish the Piperacillin-Tazobactam and Meropenem Plasmatic Levels to know if it´s necessary to make some adjustment in the recommended dose regimen.

Detailed Description

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Conditions

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Sepsis Septic Shock

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

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

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients above 18 years old.
* 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

* Patients under 18 years old.
* Pregnant women.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Spain

Central Contacts

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Marta María Pinilla de Torre

Role: CONTACT

645. 36. 83. 05

Facility Contacts

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Marta María Pinilla de Torre

Role: primary

645. 36. 83. 05

Other Identifiers

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FIS-MER-2019-01

Identifier Type: -

Identifier Source: org_study_id

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