ACTRN12612000138886已完成2 期
A phase IIb randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients BLING II
HMRC0 个研究点目标入组 442 人开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 442
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Confirmed or suspected infection with new organ dysfunction, based on established entry criteria for severe sepsis
- •2.The treating clinician has chosen ticarcillin-clavulanate, meropenem or piperacillin-tazobactam to treat the episode of infection in Criterion 1.
- •3.The treating clinician is uncertain if administration of the chosen antibiotic by bolus administration or by infusion is superior.
- •4.At the time of the assessment of suitability for the study, the treating ICU specialist expects the patient will require treatment in the ICU that extends beyond the next calendar day.
- •Organ Dysfunction Entry Criteria:
- •The patient must meet one or more the following organ dysfunction entry criteria in the previous 24 hours:
- •1.Cardiovascular (shock):
- •An arterial systolic blood pressure (SBP) of equal to 90 mmHg or a mean arterial pressure (MAP) equal to 70 mmHg for at least one hour despite adequate fluid resuscitation or adequate intravascular volume status (as previously defined), and/or need for vasopressors to achieve a SBP or MAP target (as specified by the treating physician) for greater than one hour. Vasopressors are defined as:
- •a)Dopamine greater than 5 micro g/kg/min
- •b)Noradrenaline, adrenaline, metaraminol or phenylephrine by infusion at any dose.
- •Acute kidney injury with serum creatinine greater than 1.5 x hospital admission creatinine or less than 0.5 ml/kg/hour for 6 hours. A patient with loss of kidney function or end-stage kidney disease (defined as the need for renal replacement therapy for more than 4 weeks or the need for dialysis for longer than 3 months) would need to meet one of the other organ failure criteria.
- •3.Respiratory:
- •Respiratory failure defined as PaO2/FiO2 equal to 200.
- •4.Haematology:
- •Platelet count of less than 80 x 109/L or a greater than 50% decrease in the platelet count from the highest recorded value within the preceding 3 days.
- •5.Metabolic acidosis:
- •Defined by one of the following:
- •a)pH less than 7.30
- •b)Base deficit greater than 5.0 mmol/L
- •c)A venous or arterial plasma lactate level greater than 1.5 times the upper limit of normal for the reporting laboratory.
排除标准
- •Patients meeting one or more of the following criteria are to be excluded:
- •1.Receipt of any potential study drug for more than 24 hours prior to randomisation during this admission to the ICU
- •2.Age less than 18 years
- •3.Allergy or potential allergy to the study medications
- •4.Pregnancy
- •5.No central venous catheter access with three or more lumens
- •6.Receiving palliative or supportive treatment only at the time of assessment for eligibility
- •7.Treating physician is not committed to provision of advanced life-support including any of mechanical ventilation, dialysis, and vasopressor administration for at least the next 48 hours
- •8.Death is deemed imminent and inevitable
- •9.The patient has an underlying process that is likely to result in death before 90 days of follow up.
- •10. Consent has not been gained for study participation.
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