Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 1,850
- 试验地点
- 28
- 主要终点
- Mortality
研究概览
简要总结
The objective of this trial is to assess the beneficial and harmful effects of a restrictive strategy for administration of non-resuscitation fluids in adult patients with septic shock.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The clinical team caring for participants will not be blinded due to the nature of the intervention. The participants and their family will not be actively informed about group allocation. The steering group, author group, trial statistician, outcome assessors, prognosticators, the trial coordinating team, manuscript writers and the data safety and monitoring committee will be blinded to group allocation.
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
- •Adult (≥ 18 years of age)
- •Septic shock according to the Sepsis 3 criteria at any time within 12 hours after ICU admission (suspected or confirmed infection, plasma lactate above 2 mmol/L, and infusion of vasopressor/inotrope to maintain mean arterial pressure of 65mmHg or above after receiving adequate fluid resuscitation [> 1L within 12 h of screening]) and need for vasopressors at the time of screening.
排除标准
- •Confirmed or suspected pregnancy
- •Previous inclusion in the trial
- •Screened more than 12 hours after ICU admission
研究组 & 干预措施
Usual Care
Participants receive non-resuscitation fluids according to local routines.
干预措施: Usual care (Other)
Protocolised reduction of non-resuscitation fluids
Participants receive non-resuscitation fluids according to a pre-defined protocol starting within two hours of randomization. The intervention is continued for the duration of the ICU admission up to a maximum of 90 days.
干预措施: Protocolised reduction of non-resuscitation fluids (Other)
结局指标
主要结局
Mortality
时间窗: 90 days after inclusion
All-cause mortality
次要结局
- Health-Related Quality of Life(6 months after inclusion)
- Complications in the ICU(From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days)
- Mechanical ventilation-free days(Within 90 days after inclusion)
- Cognitive function(6 months after inclusion)