Extended-infusion Piperacillin-Tazobactam Versus Intermittent-Infusion Dosing Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Infections.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Clinical cure
研究概览
简要总结
Continuous-infusion of piperacillin/tazobactam over 4 hrs instead of 30-minute intermittent dosage regimen has shown observable outcomes. Our objective is to assess whether continuous infusion of piperacillin/tazobactam is superior in terms of efficacy, safety and cost to the intermittent regimen to treat suspected or proved infections due to gram negative bacteria. The setting is Critical Care Medicine Department at Cairo University Hospitals. Methods A prospective randomized comparative study.
详细描述
A total of 56 patients were recruited from ICU- Cairo University Hospitals. All adult critically ill patients admitted to Critical Care Medicine Department with suspected or confirmed bacterial infections on admission or during their ICU stay were assessed for inclusion into the study. All patients were subjected to the following: A. Patient's full history: Age, sex ,medical history ,concurrent diseases, concurrent medications
B. Patient evaluation and assessment:
The following were evaluated at baseline and periodically thereafter until day of stopping antibiotic, discharge and/or death :
- Kidney functions (Serum creatinine, blood urea nitrogen)
- Liver functions (ALT, AST, Bil D, Bil T, Albumin)
- Complete blood count
- Microbiological Evaluation: Cultures and sensitivity tests from suspected site of infection
- Clinical signs and symptoms of infection documented by the attending physician on patient's medical record
- APACHE II Variables
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-74 years
- •Expected ICU stay more than 24 hours
排除标准
- •Allergy or potential allergy to the study medications
- •Pregnancy
- •Patients with CrCl< 20 ml/min or on dialysis
- •Cancer patients
研究组 & 干预措施
Piperacillin/Tazobactam Intermittent infusion
4.5 gm Piperacillin/Tazobactam I.V intermittent over 30 min. every 8 hours.
干预措施: Piperacillin/Tazobactam Intermittent infusion (Drug)
Piperacillin/Tazobactam Continuous infusion
4.5 gm Piperacillin/Tazobactam I.V extended infusion over 4 hours every 8 hours.
干预措施: Piperacillin/Tazobactam Continuous infusion (Drug)
结局指标
主要结局
Clinical cure
时间窗: ICU length of stay, assessed up to 30 days
Clinical cure, expressed in percentage, will be considered fulfilled if all the following criteria are met : Cure or improvement of clinical signs and symptoms caused by the infection, normalized WBCs and body temperature.
Total cost
时间窗: ICU length of stay, assessed up to 30 days
Cost in Dollars (prices of drugs ,supplies prices, preparation, administration, daily hospital stay cost )
次要结局
- Mortality(ICU length of stay, assessed up to 30 days)
- Readmission within 30- days(30 days)
- Adverse drug events(ICU length of stay, assessed up to 30 days)
- ICU Length of stay(ICU length of stay, assessed up to 30 days)
研究者
Christina Medhat
Teaching assistant
Ain Shams University