Status:
UNKNOWN
Meropenem and Ciprofloxacin Dosing in Septic Shock
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
The University of Queensland
Conditions:
Septic Shock
Eligibility:
All Genders
18-90 years
Brief Summary
Patients with septic shock may have altered volume of distribution and metabolism of antibiotics which are crucial medications for treating infections. The aim of the study is to investigate the blood...
Detailed Description
Sepsis may induce changes in renal function, increased capillary leakage and frequently blood-flow stasis in the peripheral tissues leading to an increase in the water space and diffusion distances. S...
Eligibility Criteria
Inclusion
- Age \>18 years and \<90 years
- Clinical indication for therapy of one of the study antibiotics Meropenem or Ciprofloxacin in patients diagnosed at or during admission to ICU with septic shock
- Sepsis will be defined as:
- Clinical suspicion of infection and/or Positive culture results
- Systemic inflammatory response syndrome (SIRS) as defined by 2 or more of the following:
- Core temperature \< 36o C or \> 38o C
- Tachycardia as defined by a heart rate \> 90 beats per minute
- Tachypnoea as defined by a respiratory rate greater than 20 breaths per minute OR a PaCO2 less than 32 mmHg during spontaneous ventilation OR the requirement for mechanical ventilation.
- A white blood cell count \> 12 X 109 / L OR \< 4 X 109 / L OR greater than 10 % immature (band) forms.
- Septic shock will be defined as:
- Sepsis with persistent hypotension, systolic blood pressure \< 90 mmHg or mean arterial pressure \< 65 despite adequate fluid resuscitation
- Requirement of inotropic support.
- Normal renal function as defined by:
- Serum creatinine \<170 mmol/L
Exclusion
- Pre-existing renal impairment as defined by:
- Serum creatinine above normal limits ( defined as \>500mmol/L)
- Need for renal replacement therapy
- History of allergy to study antibiotic
- Pregnancy
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02240277
Start Date
November 1 2014
End Date
March 1 2016
Last Update
September 15 2014
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark, 2100