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

NCT ID: NCT04540094

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-04-30

Brief 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.

Detailed Description

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.

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Human albumin

Intervention Type: DRUG

Any preparation of 5% Human Albumin Solution which has marketing authorisation in the UK to be used for this indication and is stocked by local hospital pharmacies at the participating sites, may be prescribed in this study

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.

Group Type: ACTIVE_COMPARATOR

Balanced crystalloid solution

Intervention Type: DRUG

Any preparation of intravenous "balanced" crystalloid which has marketing authorisation in the UK to be used for this indication and is stocked by local hospital pharmacies at the participating sites, may be prescribed in this study.

Interventions

Human albumin

Any preparation of 5% Human Albumin Solution which has marketing authorisation in the UK to be used for this indication and is stocked by local hospital pharmacies at the participating sites, may be prescribed in this study

Intervention Type: DRUG

Balanced crystalloid solution

Any preparation of intravenous "balanced" crystalloid which has marketing authorisation in the UK to be used for this indication and is stocked by local hospital pharmacies at the participating sites, may be prescribed in this study.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alasdair Gray

Role: STUDY_DIRECTOR

University of Edinburgh

Locations

Aberdeen Royal Infirmary

Aberdeen, , United Kingdom

Addenbrookes Hospital

Cambridge, , United Kingdom

Derby Teaching Hosptial NHS Foundation Trust

Derby, , United Kingdom

Royal Infirmary Edinburgh

Edinburgh, , United Kingdom

Royal Devon and Exeter Hospital

Exeter, , United Kingdom

Glasgow Royal Infirmary

Glasgow, , United Kingdom

Queen Elizabeth University Hospital

Glasgow, , United Kingdom

St Johns

Livingston, , United Kingdom

St Georges Hospital

London, , United Kingdom

University College London Hospital

London, , United Kingdom

John Radcliffe Hospital

Oxford, , United Kingdom

Royal Alexandra Hospital

Paisley, , United Kingdom

Derriford Hospital Plymouth

Plymouth, , United Kingdom

Salford Royal NHS Foundation Trust

Salford, , United Kingdom

Musgrove Park Hospital

Taunton, , United Kingdom

Countries

United Kingdom

References

Gray AJ, Oatey K, Grahamslaw J, Irvine S, Cafferkey J, Kennel T, Norrie J, Walsh T, Lone N, Horner D, Appelboam A, Hall P, Skipworth RJE, Bell D, Rooney K, Shankar-Hari M, Corfield AR; Albumin, Balanced, and Crystalloid-Sepsis (ABC-Sepsis) Investigators. Albumin Versus Balanced Crystalloid for the Early Resuscitation of Sepsis: An Open Parallel-Group Randomized Feasibility Trial- The ABC-Sepsis Trial. Crit Care Med. 2024 Oct 1;52(10):1520-1532. doi: 10.1097/CCM.0000000000006348. Epub 2024 Jun 24.

Reference Type: DERIVED

PMID: 38912884 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AC20043

Identifier Type: -

Identifier Source: org_study_id