Feasibility of 5% Albumin Compared With Balanced Crystalloid, as Intravenous Fluid Resuscitation in Adult Patients With Sepsis, Presenting as an Emergency to Hospital: ABC Sepsis Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 15
- 主要终点
- Recruitment Rate
研究概览
简要总结
The aim of this research study is to compare two different fluids (Human Albumin Solution (HAS) and Balanced Crystalloid that are given via a drip to patients with severe infection (sepsis). The investigators plan to see which fluid is better, and to see if they have a role in improving a patient's recovery time, reducing complications and the length of time they stay in hospital. This study plans to find out if there is evidence that one fluid is better overall to determine the need for a subsequent definitive trial.
详细描述
This trial will be an open label two-arm, multicentre, pragmatic, parallel group randomised trial of adult patients with community acquired sepsis recruited from the Emergency Department and Medical and Surgical Assessment Units across ~10 UK NHS Hospitals. The treatment phase will be the first 6 hours following randomisation. 30-day and 90-day follow up will be conducted using routine data only. The exception to this will be the first 50 patients enrolled in the study, Health Related Quality of Life (HRQoL) will be measured using the EQ-5D-5L at baseline, 7 days and at 180 days. At baseline, the participant or their relative will be asked to recall the quality of life 4 weeks prior to the index hospital admission. Questionnaires will be administered by direct patient completion or, postal or email survey with telephone follow up for non-responders after two mailings two weeks apart.
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
- •Adult patients (18 years or older) who present to UK NHS hospitals with community acquired sepsis meeting all of the 4 criteria:
- •Clinically suspected or proven infection resulting in principal reason for acute illness;
- •NEWS score ≥5 (or NEWS2 if adopted in recruitment site);
- •Hospital presentation within last 12hrs; and
- •Clinician decision has been made that immediate (within 1 hour) intravenous fluid resuscitation is needed.
排除标准
- •>1 litre of intravenous crystalloid fluid or any intravenous HAS administered prior to eligibility assessment;
- •Requirement for immediate surgery (within one hour of eligibility assessment);
- •Chronic renal replacement therapy;
- •Known allergy/adverse reaction to HAS;
- •Balanced crystalloid or HAS not available;
- •Known adverse reaction to blood products;
- •Palliation/end of life care (explicit decision by patient/family/carers in conjunction with clinical team that any active treatment beyond symptomatic relief is not appropriate);
- •Religious beliefs precluding HAS administration;
- •Previous recruitment in the trial;
- •Known recent severe traumatic brain injury (within 3 months);
- •Patients with permanent incapacity;
- •Known recruitment in another CTIMP studies within the last 30 days where co-enrolment has not been agreed.
研究组 & 干预措施
5% Human Albumin Solution
Participants allocated to the treatment arm will receive intravenous 5% Human Albumin Solution (HAS) administered as the sole intravenous fluid during the initial 6-hour resuscitation period. The clinician can deliver up to 10ml/kg in the first 3 hours using 250ml boluses of HAS based on clinical judgement, using clinical assessment supplemented by technology if that is their usual practice. This will be followed by repeat clinical assessment after each bolus (including vital signs; lactate testing). After 3 hours further HAS boluses up to 6 hours post-randomisation will be at clinical discretion and will be documented in the CRF. Patients in the albumin arm should not receive balanced crystalloid as a resuscitation fluid in the first 6 hours.
干预措施: Human albumin (Drug)
Intravenous balanced crystalloid
Participant allocated to the usual care arm will receive intravenous balanced crystalloid administered as the sole intravenous fluid during the initial 6 hour resuscitation period. The clinician can deliver up to 30ml/kg in the first 3 hours using 250ml boluses of balanced crystalloid based on clinical judgement, using clinical assessment supplemented by technology if that is their usual practice. This will be followed by repeat clinical assessment after each bolus (including vital signs; lactate testing). Thereafter, further crystalloid boluses up to 6 hours will be at the discretion of the clinical team and will be documented in the CRF. Patients in the balanced crystalloid arm should not receive albumin as a resuscitation fluid in the first 6 hours.
干预措施: Balanced crystalloid solution (Drug)
结局指标
主要结局
Recruitment Rate
时间窗: Approx 1 year
We measured the recruitment rate to assess deliverability. We aimed to recruit 300 participants in approximately 1 year in a 1:1 ratio into each treatment arm.
30-day Mortality
时间窗: 30 days
Assessment of how many participants in each arm died after 30 days to determine the effect size between the treatment groups.
次要结局
- Data Completeness of Primary Outcome(180 days)
- Withdrawal From Study(Approx 1 year)
- Number of Patients Who Receive Any Other Fluid Apart From Intervention or Control in First 6 Hrs After Recruitment(6 hours)
- Time to Start of In-hospital Intravenous Fluids(From time of Randomisation until fluid first being administered measured up to 6 hours.)
- In-hospital Mortality(From time of Randomisation until time of hospital discharge or death, whichever is first measured up to 90 days)
- 90-day Mortality(90 days)
- Volume of Randomised Fluid Delivered in Each Arm in the First 6hrs(6 hours)
- Length of Hospital Stay(90 days)
- Proportion of Patients Admitted to Critical Care (HDU/ICU)(90 days)
- Length of Stay in Critical Care (HDU/ICU)(90 days)
- Number of Participants Needing Intravenous Vasopressors(From time of Randomisation until time of hospital discharge, measured up to 90 days.)
- Number of Participants Needing Renal Replacement(From time of Randomisation until time of hospital discharge, measured up to 90 days.)
- Number of Participants Needing Invasive Ventilation(From time of Randomisation until time of hospital discharge, measured up to 90 days.)
- Number of Patients Readmitted in First 90 Days After Discharge(90 days)
- Number of Patients Developing Acute Kidney Injury (AKI)(7 days)
- Number of Patients Developing Pulmonary Oedema(7 days)
- Number of Patients Developing Allergy or Anaphylaxis(7 days)
- Health Related Quality of Life (EQ-5D-5L Questionnaire)(180 Days)
- Secondary Care Costs(30 days)
- Volume of Randomised Fluid Delivered in Each Arm in the First 24hrs(24 hours)