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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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
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.
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
...and 5 more locations
Recruitment Rate
We measured the recruitment rate to assess deliverability. We aimed to recruit 300 participants in approximately 1 year in a 1:1 ratio into each treatment arm.
Time frame: Approx 1 year
30-day Mortality
Assessment of how many participants in each arm died after 30 days to determine the effect size between the treatment groups.
Time frame: 30 days
Data Completeness of Primary Outcome
Feasibility Outcome assessing the number of participants who provided data for clinical primary outcome (30 day mortality)
Time frame: 180 days
Withdrawal From Study
Feasibility Outcomes assessing the number of participants who withdraw from study intervention and/or data collection
Time frame: Approx 1 year
Number of Patients Who Receive Any Other Fluid Apart From Intervention or Control in First 6 Hrs After Recruitment
Feasibility Outcome- number of patients who receive any other fluid apart from intervention or control in first 6 hrs after recruitment
Time frame: 6 hours
Time to Start of In-hospital Intravenous Fluids
Feasibility Outcome- Time to start of in-hospital intravenous fluids
Time frame: From time of Randomisation until fluid first being administered measured up to 6 hours.
In-hospital Mortality
Secondary Clinical Outcome
Time frame: From time of Randomisation until time of hospital discharge or death, whichever is first measured up to 90 days
90-day Mortality
Secondary Clinical Outcome
Time frame: 90 days
Volume of Randomised Fluid Delivered in Each Arm in the First 6hrs
Secondary Clinical Outcome- Volume of randomised fluid delivered in each arm in the first 6hrs
Time frame: 6 hours
Length of Hospital Stay
Secondary Clinical Outcome
Time frame: 90 days
Proportion of Patients Admitted to Critical Care (HDU/ICU)
Secondary Clinical Outcome- Proportion of patients admitted to critical care (HDU/ICU)
Time frame: 90 days
Length of Stay in Critical Care (HDU/ICU)
Secondary Clinical Outcome- Length of stay in critical care (HDU/ICU)
Time frame: 90 days
Number of Participants Needing Intravenous Vasopressors
Secondary Clinical Outcome-number of participants needing intravenous vasopressors
Time frame: From time of Randomisation until time of hospital discharge, measured up to 90 days.
Number of Participants Needing Renal Replacement
Secondary Clinical Outcome- Number of participants needing renal replacement
Time frame: From time of Randomisation until time of hospital discharge, measured up to 90 days.
Number of Participants Needing Invasive Ventilation
Secondary Clinical Outcome- Number of participants needing invasive ventilation
Time frame: From time of Randomisation until time of hospital discharge, measured up to 90 days.
Number of Patients Readmitted in First 90 Days After Discharge
Secondary Clinical Outcome- Number of patients readmitted in first 90 days after discharge
Time frame: 90 days
Number of Patients Developing Acute Kidney Injury (AKI)
AKI Defined using National Institute for Health and Care Excellence (NICE) criteria: A diagnosis of AKI may be made if there is one of the following: A rise in serum creatinine of 26 micromol/L or greater within 48 hours. A 50% or greater rise in serum creatinine known or presumed to have occurred within the past 7 days. A fall in urine output to less than 0.5 mL/kg/hour for more than 6 hours.
Time frame: 7 days
Number of Patients Developing Pulmonary Oedema
Safety Radiology diagnosis or requirement for rescue management (new diuretic use)
Time frame: 7 days
Number of Patients Developing Allergy or Anaphylaxis
Requirement for rescue management (antihistamines, adrenaline, intravenous fluids, steroid)
Time frame: 7 days
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. A high score indicates a worse outcome. 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. The digits for the five dimensions can be combined into a 5-digit number (profile) that describes the patient's health state. The EQ-5D profile can be converted to a single number between 0-1 called the EQ-5D value. These EQ-5D values to lie on between 0-1 to indicate health where 0 represents the minimum score (dead) and 1 is full health. Values less than 0 are possible for health states considered worse than dead.
Time frame: baseline
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.
Time frame: 30 days
Volume of Randomised Fluid Delivered in Each Arm in the First 24hrs
Secondary Clinical Outcome-Volume of randomised fluid delivered in each arm in the first 24hrs
Time frame: 24 hours
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. A high score indicates a worse outcome. 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. The digits for the five dimensions can be combined into a 5-digit number (profile) that describes the patient's health state. The EQ-5D profile can be converted to a single number between 0-1 called the EQ-5D value. These EQ-5D values to lie on between 0-1 to indicate health where 0 represents the minimum score (dead) and 1 is full health. Values less than 0 are possible for health states considered worse than dead.
Time frame: 7 Days
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. A high score indicates a worse outcome. 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. The digits for the five dimensions can be combined into a 5-digit number (profile) that describes the patient's health state. The EQ-5D profile can be converted to a single number between 0-1 called the EQ-5D value. These EQ-5D values to lie on between 0-1 to indicate health where 0 represents the minimum score (dead) and 1 is full health. Values less than 0 are possible for health states considered worse than dead.
Time frame: 180 Days
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