Feasibility of 5% Albumin Compared With Balanced Crystalloid, as Intravenous Fluid Resuscitation in Adult Patients With Sepsis, Presenting as an Emergency to Hospital

Launched by UNIVERSITY OF EDINBURGH · Sep 4, 2020

Keywords

ClinConnect Summary

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 baseli...

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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:
• • 1. Clinically suspected or proven infection resulting in principal reason for acute illness;
• • 2. NEWS score ≥5 (or NEWS2 if adopted in recruitment site);
• • 3. Hospital presentation within last 12hrs; and
• • 4. Clinician decision has been made that immediate (within 1 hour) intravenous fluid resuscitation is needed.
• Exclusion Criteria:
• • 1. \>1 litre of intravenous crystalloid fluid or any intravenous HAS administered prior to eligibility assessment;
• • 2. Requirement for immediate surgery (within one hour of eligibility assessment);
• • 3. Chronic renal replacement therapy;
• • 4. Known allergy/adverse reaction to HAS;
• • 5. Balanced crystalloid or HAS not available;
• • 6. Known adverse reaction to blood products;
• • 7. 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);
• • 8. Religious beliefs precluding HAS administration;
• • 9. Previous recruitment in the trial;
• • 10. Known recent severe traumatic brain injury (within 3 months);
• • 11. Patients with permanent incapacity;
• • 12. Known recruitment in another CTIMP studies within the last 30 days where co-enrolment has not been agreed.