Feasibility of 5% Albumin compared with Balanced Crystalloid, as intravenous fluid resuscitation in adult patients with sepsis, presenting as an emergency to hospital

This trial is an open label two-arm randomised trial focused on identifying the best treatment for community acquired sepsis patients. We will be investigating the feasibility of delivering early intravenous fluid resuscitation by comparing 5% human albumin solution (HAS) to balanced crystalloid. Currently, balanced crystalloids are used as routine care and the first line therapy in the international sepsis guidelines, whereas HAS is the second line fluid therapy in septic shock. Although, studies are showing that HAS may have further potential benefits to patients with sepsis.

The study aims to recruit 300 patients who meet the following inclusion criteria:

  1. Clinically suspected or proven infection resulting in principal reason for acute illness;
  2. NEWS/NEWS2 score ≥5;
  3. Hospital presentation within last 12hrs;
  4. 4.Clinician decision has been made that immediate (within 1 hour of assessment) intravenous fluid resuscitation is needed; and;
  5. Ability to obtain informed consent.

Patients will be recruited in the Emergency Department and Medical and Surgical Assessment Units across UK NHS hospitals. The treatment will be administered within the first 6 hours of randomisation. Following this, patients will be reviewed for safety reasons and asked to complete a questionnaire in order to evaluate thier quality of life.

Status: active

Start Date

May 2021

Chief Investigator

Professor Alasdair Gray

Coordinated by

Julia Grahamslaw

Main Trial Site

Royal Infirmary of Edinburgh

End date

March 2022