Monitoring of Piperacillin-Tazobactam and Meropenem Plasmatic Levels in Critical Patients
- Conditions
- Septic ShockSepsis
- Interventions
- Registration Number
- NCT04257838
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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).
- Patients under 18 years old.
- Pregnant women.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Piperacillin-Tazobactam or Meropenem Cohort Piperacillin/tazobactam or Meropenem 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.
- Primary Outcome Measures
Name Time Method Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy . Up to 12 months after the antibiotic administration The chosen efficiency parameter is that 100 % of the time the concentration remains 4 times above the minimum inhibitory concentration (MIC), the exact minimum inhibitory concentration (MIC) of the used antibiotic will be determined by E-test by the Microbiology Service which means that the seric concentrations asociated with the maximum therapeutic efficacy are:
* For Meropenem 2mg/dl, which means reaching a concentration in T0 \>8 mg/dL.
* For Piperacillin-Tazobactam 16 mg/dL, which means reaching a concentration in T0 \>64 mg/dL.
- Secondary Outcome Measures
Name Time Method 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. Up to 12 months after the antibiotic administration The seric concentrations asociated with the maximum therapeutic efficacy are the same as the described for the description of the Primary Outcome Measure and it´s considered that a patient has renal hyper clearance when they have a creatinine clearance above 130 ml/min.
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. Up to 12 months after the antibiotic administration The seric concentrations asociated with the maximum therapeutic efficacy are the same as the described for the description of the Primary Outcome Measure and it´s considered that a patient has Gram-negative bacillary bacteremia when the bloodstream is invaded by Gram-negative bacillary which is diagnosed by blood culture.
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. Up to 12 months after the antibiotic administration The seric concentrations asociated with the maximum therapeutic efficacy are the same as the described for the description of the Primary Outcome Measure and a patient with continuous renal replacement technique, has its blood purified extracorporeally, replacing the renal function continuously 24 hours of the day.
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. Up to 12 months after the antibiotic administration The seric concentrations asociated with the maximum therapeutic efficacy are the same as the described for the description of the Primary Outcome Measure and a patient with ExtraCorporeal Membrane Oxygenation has a short-term extracorporeal circulatory and respiratory mechanical assistance system.
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. Up to 12 months after the antibiotic administration The seric concentrations asociated with the maximum therapeutic efficacy are the same as the described for the description of the Primary Outcome Measure and it´s considered that a patient has morbid obesity when it´s BMI (body mass index) is above 40.
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. Up to 12 months after the antibiotic administration 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.
Determine the association between the supra-therapeutic levels and the appearance of toxicity. Up to 12 months after the antibiotic administration Determination of if there´s an association between the antibiotics supra-therapeutic levels and the toxicity appearance.
Trial Locations
- Locations (1)
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain