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)
Sepsis
About this trial
This is an interventional treatment trial for Sepsis focused on measuring Sepsis, Emergency Care, Albumin, Crystalloid, Fluid, Resuscitation
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- >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.
Sites / Locations
- Aberdeen Royal Infirmary
- Addenbrookes Hospital
- Derby Teaching Hosptial NHS Foundation Trust
- Royal Infirmary Edinburgh
- Royal Devon and Exeter Hospital
- Glasgow Royal Infirmary
- Queen Elizabeth University Hospital
- St Johns
- St Georges Hospital
- University College London Hospital
- John Radcliffe Hospital
- Royal Alexandra Hospital
- Derriford Hospital Plymouth
- Salford Royal NHS Foundation Trust
- Musgrove Park Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
5% Human Albumin Solution
Intravenous balanced crystalloid
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.
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.