Clinical trial NCT04540094: Feasibility of 5% Albumin Compared With Balanced Crystalloid, as Intravenous Fluid Resuscitation in Adult Patients With Sepsis, Presenting as an Emergency to Hospital
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sepsis
Keywords: Sepsis
Emergency Care
Albumin
Crystalloid
Fluid
Resuscitation
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label two-arm, multicentre, pragmatic, parallel group randomised trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Recruitment Rate
timeFrame: Approx 1 year
measure: 30-day Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Data Completeness of Primary Outcome
timeFrame: 180 days
measure: Withdrawal From Study
timeFrame: Approx 1 year
measure: Number of Patients Who Receive Any Other Fluid Apart From Intervention or Control in First 6 Hrs After Recruitment
timeFrame: 6 hours
measure: Time to Start of In-hospital Intravenous Fluids
timeFrame: From time of Randomisation until fluid first being administered measured up to 6 hours.
measure: In-hospital Mortality
timeFrame: From time of Randomisation until time of hospital discharge or death, whichever is first measured up to 90 days
measure: 90-day Mortality
timeFrame: 90 days
measure: Volume of Randomised Fluid Delivered in Each Arm in the First 6hrs
timeFrame: 6 hours
measure: Length of Hospital Stay
timeFrame: 90 days
measure: Proportion of Patients Admitted to Critical Care (HDU/ICU)
timeFrame: 90 days
measure: Length of Stay in Critical Care (HDU/ICU)
timeFrame: 90 days
measure: Number of Participants Needing Intravenous Vasopressors
timeFrame: From time of Randomisation until time of hospital discharge, measured up to 90 days.
measure: Number of Participants Needing Renal Replacement
timeFrame: From time of Randomisation until time of hospital discharge, measured up to 90 days.
measure: Number of Participants Needing Invasive Ventilation
timeFrame: From time of Randomisation until time of hospital discharge, measured up to 90 days.
measure: Number of Patients Readmitted in First 90 Days After Discharge
timeFrame: 90 days
measure: Number of Patients Developing Acute Kidney Injury (AKI)
timeFrame: 7 days
measure: Number of Patients Developing Pulmonary Oedema
timeFrame: 7 days
measure: Number of Patients Developing Allergy or Anaphylaxis
timeFrame: 7 days
measure: Health Related Quality of Life (EQ-5D-5L Questionnaire)
timeFrame: baseline
measure: Secondary Care Costs
timeFrame: 30 days
measure: Volume of Randomised Fluid Delivered in Each Arm in the First 24hrs
timeFrame: 24 hours
measure: Health Related Quality of Life (EQ-5D-5L Questionnaire)
timeFrame: 7 Days
measure: Health Related Quality of Life (EQ-5D-5L Questionnaire)
timeFrame: 180 Days
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Derby
country: United Kingdom
facility: Derby Teaching Hosptial NHS Foundation Trust
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary Edinburgh
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Livingston
country: United Kingdom
facility: St Johns
city: London
country: United Kingdom
facility: St Georges Hospital
city: London
country: United Kingdom
facility: University College London Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Paisley
country: United Kingdom
facility: Royal Alexandra Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital Plymouth
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
Study officials:
affiliation: University of Edinburgh
name: Alasdair Gray
role: STUDY_DIRECTOR
References: