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

Sepsis Clinical Trial

— ABC Sepsis  

Official title:

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 Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04540094
• Other study ID #: AC20043
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 1, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: March 2022
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: April 30, 2023
• Est. primary completion date: September 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• Toxemia

Intervention

Drug:
• 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
• 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.

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	To assess deliverability	Approx 1 year
Primary	30-day mortality	To determine effect size	30 days
Secondary	Data completeness	Feasibility Outcome assessing the percentage of missing data fields in the eCRF	180 days
Secondary	Withdrawal from study	Feasibility Outcomes assessing the number of participants who withdraw from study intervention and/or data collection	Approx 1 year
Secondary	Proportion of patients who receive any other fluid apart from intervention or control in first 6 hrs after recruitment	Feasibility Outcomes	6 hours
Secondary	Time to start of in-hospital intravenous fluids	Feasibility Outcomes	From time of Randomisation until fluid first being administered measured up to 6 hours.
Secondary	In-hospital mortality	Secondary Clinical Outcome	From time of Randomisation until time of hospital discharge or death, whichever is first measured up to 90 days
Secondary	90-day mortality	Secondary Clinical Outcome	90 days
Secondary	Volume of randomised fluid delivered in each arm in the first 6hrs and 24hrs	Secondary Clinical Outcome	24 hours
Secondary	Length of hospital stay	Secondary Clinical Outcome	90 days
Secondary	Proportion of patients admitted to critical care (HDU/ICU)	Secondary Clinical Outcome	90 days
Secondary	Length of stay in critical care (HDU/ICU)	Secondary Clinical Outcome	90 days
Secondary	Proportion of participants needing intravenous vasopressors	Secondary Clinical Outcome	From time of Randomisation until time of hospital discharge, measured up to 90 days.
Secondary	Proportion of participants needing renal replacement	Secondary Clinical Outcome	From time of Randomisation until time of hospital discharge, measured up to 90 days.
Secondary	Proportion of participants needing invasive ventilation	Secondary Clinical Outcome	From time of Randomisation until time of hospital discharge, measured up to 90 days.
Secondary	Proportion of patients readmitted in first 90 days after discharge	Secondary Clinical Outcome	90 days
Secondary	Proportion of patients developing acute kidney injury	Defined by NICE (https://cks.nice.org.uk/acute-kidney-injury#!scenario)	7 days
Secondary	Proportion of patients developing pulmonary oedema	Safety Radiology diagnosis or requirement for rescue management (new diuretic use)	7 days
Secondary	Proportion of patients developing allergy or anaphylaxis	Requirement for rescue management (antihistamines, adrenaline, intravenous fluids, steroid)	7 days
Secondary	Health Related Quality of life (EQ-5D-5L Questionnaire)	Health Economic Outcomes are measured using the the 5-level EQ-5D version (EQ-5D-5L). The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	180 days
Secondary	Secondary care costs	Costs will be estimated by assigning national standard unit costs to inpatient stays (critical care and general ward level), readmissions and additional high costs activities observed in the study. Baseline (pre-admission) HQoL will be estimated using age/sex matched population reference data.	30 days