Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients: A Multicentre Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 98
- 试验地点
- 8
- 主要终点
- Difference in fluid administration
研究概览
简要总结
The objectives of this feasibility trial are to assess the efficacy and feasibility of methods and procedures of a protocol purposed to compare a reduction of administration of non-resuscitation fluids to usual care in 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
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The clinical team caring for participants will not be blinded due to nature of the intervention. The participants, their family and health personnel responsible for outcome assessment at follow-up will be blinded to the allocation of the intervention. The steering group, author group, trial statistician, outcome assessors, prognosticators, statisticians, and the trial coordinating team 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: suspected or confirmed infection AND infusion of vasopressor/inotrope to maintain mean arterial pressure of 65 mmHg or above despite adequate fluid resuscitation AND lactate of 2 mmol/L or above at any time following ICU admission when there was a simultaneous need for vasopressor/inotrope.
- •Inclusion within 12 hours after ICU admission.
排除标准
- •Confirmed or suspected pregnancy
研究组 & 干预措施
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)
Usual Care
Participants receive non-resuscitation fluids according to local routines.
干预措施: Usual care (Other)
结局指标
主要结局
Difference in fluid administration
时间窗: Within the first three days after inclusion (days 0-3)
Total difference in litres of administered fluids between groups
次要结局
- Inclusion of eligible patients(During inclusion)
- Protocol violations(Within 90 days after inclusion)
- Proportion of participants with sufficient clinical outcome data(Within 90 days after inclusion)
- Proportion of participants assessed by EQ5D-5L and MoCA(6 months after inclusion)