Clinical trial NCT04257838: Monitoring of Piperacillin-Tazobactam and Meropenem Plasmatic Levels in Critical Patients
Official title: Monitoring of Piperacillin-Tazobactam and Meropenem Plasmatic Levels in Critical Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Septic Shock
Keywords: Sepsis
Septic Shock
Piperacillin-Tazobactam
Meropenem
Plasmatic Levels
Critical Patients
Dose adjustment
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sepsis or septic shock who are being treated with Meropenem or Piperacillin-Tazobactam and meet the following criteria and none of the exclusion criteria.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy .
timeFrame: Up to 12 months after the antibiotic administration
Secondary outcomes:
measure: Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with renal hyper clearance.
timeFrame: Up to 12 months after the antibiotic administration
measure: Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with Gram-negative bacillary bacteremia.
timeFrame: Up to 12 months after the antibiotic administration
measure: Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with continuous renal replacement technique.
timeFrame: Up to 12 months after the antibiotic administration
measure: Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with ExtraCorporeal Membrane Oxygenation.
timeFrame: Up to 12 months after the antibiotic administration
measure: Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with morbid obesity.
timeFrame: Up to 12 months after the antibiotic administration
measure: Determine in the total cohort if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy.
timeFrame: Up to 12 months after the antibiotic administration
measure: Determine the association between the supra-therapeutic levels and the appearance of toxicity.
timeFrame: Up to 12 months after the antibiotic administration
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: José Garnacho Montero
role: PRINCIPAL_INVESTIGATOR
References: