MEROPENEM and CIPROFLOXACIN DOSING IN THE CRITICALLY ILL PATIENT WITH SEPTIC SHOCK – A SINGLE CENTER PHARMACOKINETIC STUDY

Dept. of Intensive Care Medicine, Copenhagen University Hospital, Rigshospitalet0 个研究点目标入组 50 人开始时间: 2014年6月26日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•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.
•a. Sepsis will be defined as:
•i. Clinical suspicion of infection and/or Positive culture results
•ii. Systemic inflammatory response syndrome (SIRS) as defined by 2 or more of the following:
•iii. Core temperature < 36o C or > 38o C
•iv. Tachycardia as defined by a heart rate > 90 beats per minute
•v. 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.
•vi. A white blood cell count > 12 X 109 / L OR < 4 X 109 / L OR greater than 10 % immature (band) forms.
•b. Septic shock will be defined as:
•i. Sepsis with persistent hypotension, systolic blood pressure < 90 mmHg or mean arterial pressure < 65 despite adequate fluid resuscitation or
•ii. Requirement of inotropic support.
•> Normal renal function as defined by:
•i. Serum creatinine <170 mmol/L
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 35

•-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

发起方

Dept. of Intensive Care Medicine, Copenhagen University Hospital, Rigshospitalet