Sepsis, Septic Shock
Conditions
Keywords
Sepsis, Septic Shock, Piperacillin-Tazobactam, Meropenem, Plasmatic Levels, Critical Patients, Dose adjustment
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.
Interventions
DRUGPiperacillin/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.
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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. |
Countries
Spain
Contacts
Primary ContactMarta María Pinilla de Torre
Outcome results
None listed