Comparison of Plasmalyte 148® and Saline for Fluid Resuscitation and Intravenous Fluid Therapy in Critically Ill Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5,037
- 试验地点
- 51
- 主要终点
- Death from all causes
研究概览
简要总结
The aim of PLUS is to conduct a multi-centre, blinded, randomised, controlled trial (RCT) to determine whether fluid resuscitation and therapy with a "balanced" crystalloid solution (Plasma-Lyte 148®) decreases 90-day mortality in critically ill patients requiring fluid resuscitation when compared with the same treatment using 0.9% sodium chloride (saline)
详细描述
Fluid resuscitation is a fundamental component of the management of acutely and critically ill patients and the choice of fluid is a longstanding issue of debate.
Worldwide, 0.9% saline has traditionally been the most widely used resuscitation fluid, however its use is increasingly challenged by emerging evidence that suggests its high chloride content may have clinically important adverse effects and that resuscitation with so-called "balanced" or "buffered" crystalloids (such as Plasma-Lyte 148®) offer patients better outcomes.
Given the limitations of current evidence, there is now a scientific, ethical and health economic imperative to provide an accurate and reliable estimate of the comparative risks versus benefit of Plasma-Lyte 148® versus 0.9% saline.
The PLUS study is a prospective, multi-centre, parallel group, concealed, blinded, randomised, controlled trial.
The study will test the hypothesis that in a heterogeneous population of critically ill adults, random assignment to Plasma-Lyte 148® for intravascular volume resuscitation and crystalloid fluid therapy in the Intensive Care Unit (ICU) results in different 90-day all-cause mortality when compared with random assignment to 0.9% sodium chloride (saline) for the same treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient will receive fluid resuscitation defined as a bolus of fluid, prescribed to be administered over one hour or less to increase or maintain intravascular volume that is in addition to maintenance fluids, or specific fluids used to replace non-physiological fluid losses
- •The patient is expected to be in the ICU the day after tomorrow
- •The patient is not expected to be well enough to be eating tomorrow
- •An arterial or central venous catheter is in situ, or placement is imminent as part of routine management
- •Both Plasma-Lyte 148® and 0.9% saline are considered equally appropriate for the patient
- •The requirement for fluid resuscitation is supported by at least one of seven pre-specified clinical signs: heart rate > 90 beats per minute; systolic blood pressure < 100 mmHg or mean arterial pressure < 75 mmHg; central venous pressure < 10 mmHg; pulmonary artery wedge pressure < 12 mmHg; capillary refill time > 1 second; OR urine output < 0.5 ml/kg for at least one hour
排除标准
- •Age less than 18 years
- •Patients who have received more than 500mls of fluid resuscitation (as defined above) prescribed in the ICU during this current ICU admission
- •Patients transferred directly from another ICU who have received more than 500mls of fluid resuscitation (as defined above) during that ICU admission
- •Contraindication to either study fluid e.g. previous allergic reaction to Plasma-Lyte 148®
- •Patients admitted to the ICU with specific fluid requirements: the treatment of burns; following liver transplantation surgery; for correction of specific electrolyte abnormalities
- •Patients with traumatic brain injury or those considered at risk of developing cerebral oedema
- •Patients in whom death is deemed imminent and inevitable
- •Patients with an underlying disease process with a life expectancy of <90 days
- •Patients in whom it is unlikely the primary outcome can be ascertained
- •Patients who have previously been enrolled in PLUS
- •Known or suspected pregnancy
研究组 & 干预措施
Plasma-Lyte 148®
Following randomisation, each study participant will receive either Plasma-Lyte 148® or 0.9% saline alone for all resuscitation episodes and for all compatible intravenous crystalloid therapy while in ICU (for up to 90 days).
干预措施: Plasma-Lyte 148® (Drug)
0.9% sodium chloride
Following randomisation, each study participant will receive either Plasma-Lyte 148® or 0.9% saline alone for all resuscitation episodes and for all compatible intravenous crystalloid therapy while in ICU (for up to 90 days).
干预措施: 0.9% sodium chloride (Drug)
结局指标
主要结局
Death from all causes
时间窗: At 90 days after randomisation
次要结局
- Duration of ICU stay(28 days and 90 days after randomisation)
- Proportion of patients treated with and duration of treatment with vasoactive drugs(90 days after randomisation)
- Mean and peak serum creatinine concentration(First seven days)
- Quality of life assessment using the EQ-5D-5L questionnaire(At 6 months after randomisation)
- Maximum post-randomisation increase in serum creatinine in ICU during the index hospital admission.(90 days after randomisation)
- Duration of mechanical ventilation in ICU(90 days after randomisation)
- Healthcare services usage during the six months after randomisation by healthcare record linkage using state and national data linkage units(During the six months after randomisation)
- ICU, hospital and 28 day all-cause mortality(28 days and 6 months after randomisation)
- Proportion of patients newly treated with renal replacement therapy(up to 90 days after randomisation.)
- Duration of Hospital stay(28 days and 90 days after randomisation)