Small Volume Fluid Resuscitation and Supplementation With 20% albumIn Versus Buffered Crystalloids in PatiEnts With Septic Shock
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Participant recruitment rate
研究概览
简要总结
Sepsis is an increasingly recognised burden to healthcare systems worldwide. Intravenous fluid therapy is a common first-line intervention recommended by international guidelines. Hyperoncotic preparations of human albumin solution are widely available, but their efficacy has yet to be proven.
This randomised feasibility trial will test whether it is feasible to administer hyperoncotic albumin solutions as both fluid resuscitation and as a regular supplement in patients with early septic shock.
详细描述
Background to this research
Sepsis is the most severe type of infection. It happens when a patient's own immune system is trying to fight an infection, but causes damage or even failure to vital organs such as the heart, lungs or kidneys. It is a life-threatening condition and even with prompt treatment as many as 1 in 4 patients with sepsis don't survive. Septic shock is a term used to describe the worst form of sepsis, where patients need life-supporting treatments in intensive care.
Guidelines recommend doctors give fluid to patients with sepsis. This aims to improve blood flow to vital organs and reduce the risk of further damage. However, there maybe risks if patients are given too much fluid, such as developing kidney failure or even death.
Human albumin solution is a type of fluid, made from blood donated by healthy volunteers. Albumin has been used safely for many years but is more expensive compared to other fluids. Alternative fluids include solutions of salts and water that closely match the contents of human blood. Some research suggests patients with sepsis might benefit from being given albumin, particularly those with septic shock, but doctors remain unsure on whether they should give it to patients with sepsis, or whether the additional expense is worthwhile.
The overall aims of this research
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
- None
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
- •Suspected or documented infection
- •Organ dysfunction defined as SOFA score ≥2
- •Need for vasopressor infusion for ≥2 hours
- •Serum lactate ≥2 mmol/L
- •Eligible for critical care admission without any restrictions
排除标准
- •>24 hours since the time point of meeting all inclusion criteria
- •<18 years of age
- •Patients with a known allergy to albumin
- •Jehova's witnesses or other patients expressing a known objection to the use of blood products
- •Previous receipt of human albumin solution for the episode of sepsis in question
- •Previous enrolment in this study
研究组 & 干预措施
Hyperoncotic albumin
Hyperoncotic albumin for all fluid resuscitation and also as a daily supplement, guided by daily serum albumin values, for up to 7 days.
干预措施: hyperoncotic human albumin solution (Drug)
Buffered crystalloids
Buffered crystalloid solutions for all fluid resuscitation and maintenance purposes. Participants in this arms will NOT receive any albumin during their participation.
干预措施: Buffered crystalloid solutions (Drug)
结局指标
主要结局
Participant recruitment rate
时间窗: 24 months after opening the trial
Evidence to confirm feasibility of the study protocol without any further modification for a future efficacy trial. This will be objectively determined by a recruitment rate of \>2 participants per month, resulting in study recruitment being completed within 24 months of opening the trial. A pre-specified threshold of \>80% of the anticipated recruitment rate would support the feasibility of a future efficacy trial.
次要结局
- Vasopressor use(hourly values for up to 7-days)
- Survival(90-days after enrolment)
- Quality of Life of study participants(90-days after enrolment)
- Cumulative fluid balance (in millilitres)(daily values for up to 7 days)
- Healthcare costs(90-days after enrolment)