Protocolised Early De-Resuscitation in Septic Shock (REDUCE) - a Randomised Controlled Multi-centre Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 4
- 主要终点
- Proportion of patient with a negative fluid balance on day 3
研究概览
简要总结
Background: Recent studies have questioned the safety of current fluid resuscitation strategies in patients with septic shock as prospective and observational data suggesting that the resulting fluid overload is associated with mortality. Two strategies have evolved to prevent or minimize fluid overload: restrictive fluid administration or active removal of accumulated fluid. While several small trials show benefits with a restrictive fluid administration regimen, active protocolized de-resuscitation was scarcely evaluated. The combination of both strategies yet warrants systematic evaluation.
Aim: This study aims to assess the efficacy and feasibility of an early active de-resuscitation protocol in patients with septic shock. We hypothesize that the application of a structured early de-resuscitation protocol versus standard of care will lead to less fluid overload at day three after ICU admission.
Study Intervention: Patients admitted to the ICU with confirmed or suspected septic shock (Sepsis-3 definition) will be randomized (1:1) to either the intervention or standard of care. In the intervention arm, patients are managed according to the REDUCE fluid management protocol during resuscitation and de-resuscitation.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to the treatment 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
- •Patients admitted to ICU with the diagnosis of septic shock as defined according to the Sepsis-3 criteria (suspected or confirmed infection AND vasopressor/inotrope ongoing to maintain MAP ≥ 65 mmHg AND Lactate ≥ 2 mmol/l in the last 6 hours
排除标准
- •Age <18 years
- •Septic shock for more than 12 hours at the time of screening
- •Acute burn injury >/= 10% of the body surface area
- •Known pregnancy or lactating women
- •Consent not obtainable due to national legislation
- •Patients on chronic dialysis
- •Patients that are known to be allergic to furosemide or metolazone
研究组 & 干预措施
Intervention: REDUCE Protocol
Fluid resuscitation and de-resuscitation is based on the REDUCE fluid management protocol.
干预措施: Fluid management according to the REDUCE Fluid Protocol (Other)
Standard of Care
Fluid resuscitation and de-resuscitation according to the standard of care
干预措施: Standard of care (Other)
结局指标
主要结局
Proportion of patient with a negative fluid balance on day 3
时间窗: Up to day 3 after ICU admission
Proportion of patients with a negative cumulative fluid balance on day 3
次要结局
- Vasopressor-free days at day 30(Up to 30 days after randomisation)
- Ventilator-free days at day 30(Up to 30 days after randomisation)
- All-cause mortality(Up to 90 days after randomisation)
- Number of patients with fluid overload at day 3 and ICU discharge(From hospital admission to the end of ICU stay, on average after 7 days)
- Number of patients with need for renal replacement at 90days(Up to 90 days after randomisation)
- Feasibility of the REDUCE fluid protocol(From randomisation until the end of ICU stay, on average after 7 days)
- Incidence of ischemic events and severe AKI(Ischemic events and AKI: From randomisation until the end of ICU stay (on average after 7 days), and at day 30; electrolyte and acid-base/medication associated safety endpoints: during ICU stay (on average 7 days))
- Renal replacement therapy(Up to 90 days after randomisation)