Septic Shock Clinical Trial
Official title:
Meropenem and Ciprofloxacin Dosing in the Critically Ill Patient With Septic Shock - a Single Center Pharmacokinetic Study
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 concentrations of Meropenem and Ciprofloxacin, two commonly used antibiotics, in patients with septic shock. The hypothesis is that standard dosing may produce insufficient levels of antibiotics in patients with septic shock.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | March 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | The University of Queensland |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area Under the Concentration-Time Curve (AUC 0-8h) | The concentration versus time data for meropenem & ciprofloxacin in plasma will be analysed by a non-linear mixed effects modelling approach using NONMEM (Version 7.3, GloboMax LLC, Hanover, MD, USA) with double precision with the COMPAQ VISUAL FORTRAN compiler | Seven blood samples of 3 ml at T0 (pre dose), 30, 45, 60, 120, 240 and 480 mins post infusion completion. | No |
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