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

• Status: Not yet recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Edinburgh
• Collaborator: Edinburgh Clinical Trials Unit

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.