Sepsis
Conditions
Keywords
Sepsis, Emergency Care, Albumin, Crystalloid, Fluid, Resuscitation
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.
Interventions
DRUGHuman 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
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.
Sponsors
University of Edinburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label two-arm, multicentre, pragmatic, parallel group randomised trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | Approx 1 year | 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. |
| 30-day Mortality | 30 days | Assessment of how many participants in each arm died after 30 days to determine the effect size between the treatment groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Receive Any Other Fluid Apart From Intervention or Control in First 6 Hrs After Recruitment | 6 hours | Feasibility Outcome- number of patients who receive any other fluid apart from intervention or control in first 6 hrs after recruitment |
| Time to Start of In-hospital Intravenous Fluids | From time of Randomisation until fluid first being administered measured up to 6 hours. | Feasibility Outcome- Time to start of in-hospital intravenous fluids |
| In-hospital Mortality | From time of Randomisation until time of hospital discharge or death, whichever is first measured up to 90 days | Secondary Clinical Outcome |
| 90-day Mortality | 90 days | Secondary Clinical Outcome |
| Volume of Randomised Fluid Delivered in Each Arm in the First 6hrs | 6 hours | Secondary Clinical Outcome- Volume of randomised fluid delivered in each arm in the first 6hrs |
| Length of Hospital Stay | 90 days | Secondary Clinical Outcome |
| Proportion of Patients Admitted to Critical Care (HDU/ICU) | 90 days | Secondary Clinical Outcome- Proportion of patients admitted to critical care (HDU/ICU) |
| Length of Stay in Critical Care (HDU/ICU) | 90 days | Secondary Clinical Outcome- Length of stay in critical care (HDU/ICU) |
| Number of Participants Needing Intravenous Vasopressors | From time of Randomisation until time of hospital discharge, measured up to 90 days. | Secondary Clinical Outcome-number of participants needing intravenous vasopressors |
| Data Completeness of Primary Outcome | 180 days | Feasibility Outcome assessing the number of participants who provided data for clinical primary outcome (30 day mortality) |
| Number of Participants Needing Invasive Ventilation | From time of Randomisation until time of hospital discharge, measured up to 90 days. | Secondary Clinical Outcome- Number of participants needing invasive ventilation |
| Number of Patients Readmitted in First 90 Days After Discharge | 90 days | Secondary Clinical Outcome- Number of patients readmitted in first 90 days after discharge |
| Number of Patients Developing Acute Kidney Injury (AKI) | 7 days | 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. |
| Number of Patients Developing Pulmonary Oedema | 7 days | Safety Radiology diagnosis or requirement for rescue management (new diuretic use) |
| Number of Patients Developing Allergy or Anaphylaxis | 7 days | Requirement for rescue management (antihistamines, adrenaline, intravenous fluids, steroid) |
| Health Related Quality of Life (EQ-5D-5L Questionnaire) | baseline | 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. |
| Secondary Care Costs | 30 days | 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. |
| Volume of Randomised Fluid Delivered in Each Arm in the First 24hrs | 24 hours | Secondary Clinical Outcome-Volume of randomised fluid delivered in each arm in the first 24hrs |
| Number of Participants Needing Renal Replacement | From time of Randomisation until time of hospital discharge, measured up to 90 days. | Secondary Clinical Outcome- Number of participants needing renal replacement |
| Withdrawal From Study | Approx 1 year | Feasibility Outcomes assessing the number of participants who withdraw from study intervention and/or data collection |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 150 |
| 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.
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. | 150 |
| Total | 300 |
Baseline characteristics
| Characteristic | Intravenous Balanced Crystalloid | Total | 5% Human Albumin Solution |
|---|---|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 18 | 69 years STANDARD_DEVIATION 16 | 70 years STANDARD_DEVIATION 15 |
| Lactate | 3 mmol/l STANDARD_DEVIATION 2 | 3 mmol/l STANDARD_DEVIATION 3 | 3 mmol/l STANDARD_DEVIATION 3 |
| National Early Warning Score (NEWS) Score | 8.3 units on a scale STANDARD_DEVIATION 2.7 | 8.1 units on a scale STANDARD_DEVIATION 2.5 | 8 units on a scale STANDARD_DEVIATION 2.4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 70 Participants | 149 Participants | 79 Participants |
| Sex: Female, Male Male | 80 Participants | 151 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 43 / 150 | 32 / 150 |
| other Total, other adverse events | 25 / 150 | 20 / 150 |
| serious Total, serious adverse events | 5 / 150 | 2 / 150 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5% Human Albumin Solution | 30-day Mortality | 31 Participants |
| Intravenous Balanced Crystalloid | 30-day Mortality | 22 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5% Human Albumin Solution | Recruitment Rate | 150 Participants |
| Intravenous Balanced Crystalloid | Recruitment Rate | 150 Participants |
Secondary
90-day Mortality
Secondary Clinical Outcome
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5% Human Albumin Solution | 90-day Mortality | 43 Participants |
| Intravenous Balanced Crystalloid | 90-day Mortality | 32 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5% Human Albumin Solution | Data Completeness of Primary Outcome | 147 Participants |
| Intravenous Balanced Crystalloid | Data Completeness of Primary Outcome | 149 Participants |
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. 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
Population: Health Related Quality of life questionnaires were applicable only to the first 50 participants who entered the study. As this is a self-reported questionnaire, participants may not be well enough to complete this at any given time-point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 5% Human Albumin Solution | Health Related Quality of Life (EQ-5D-5L Questionnaire) | 0.4 units on a scale |
| Intravenous Balanced Crystalloid | Health Related Quality of Life (EQ-5D-5L Questionnaire) | 0.5 units on a scale |
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. 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
Population: Health Related Quality of life questionnaires were applicable only to the first 50 participants who entered the study. As this is a self-reported questionnaire, participants may not be well enough to complete this at any given time-point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 5% Human Albumin Solution | Health Related Quality of Life (EQ-5D-5L Questionnaire) | 0.8 score on a scale |
| Intravenous Balanced Crystalloid | Health Related Quality of Life (EQ-5D-5L Questionnaire) | 0.5 score on a scale |
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. 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
Population: Health Related Quality of life questionnaires were applicable only to the first 50 participants who entered the study. As this is a self-reported questionnaire, participants may not be well enough to complete this at any given time-point.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 5% Human Albumin Solution | Health Related Quality of Life (EQ-5D-5L Questionnaire) | 0.4 score on a scale |
| Intravenous Balanced Crystalloid | Health Related Quality of Life (EQ-5D-5L Questionnaire) | 0.5 score on a scale |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5% Human Albumin Solution | In-hospital Mortality | 29 Participants |
| Intravenous Balanced Crystalloid | In-hospital Mortality | 23 Participants |
Secondary
Length of Hospital Stay
Secondary Clinical Outcome
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5% Human Albumin Solution | Length of Hospital Stay | 12.7 days | Standard Deviation 15.9 |
| Intravenous Balanced Crystalloid | Length of Hospital Stay | 13.9 days | Standard Deviation 19.3 |
Secondary
Length of Stay in Critical Care (HDU/ICU)
Secondary Clinical Outcome- Length of stay in critical care (HDU/ICU)
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5% Human Albumin Solution | Length of Stay in Critical Care (HDU/ICU) | 1.3 days | Standard Deviation 5.9 |
| Intravenous Balanced Crystalloid | Length of Stay in Critical Care (HDU/ICU) | 1.5 days | Standard Deviation 5.4 |
Secondary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5% Human Albumin Solution | Number of Participants Needing Intravenous Vasopressors | 18 Participants |
| Intravenous Balanced Crystalloid | Number of Participants Needing Intravenous Vasopressors | 12 Participants |
Secondary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5% Human Albumin Solution | Number of Participants Needing Invasive Ventilation | 7 Participants |
| Intravenous Balanced Crystalloid | Number of Participants Needing Invasive Ventilation | 4 Participants |
Secondary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5% Human Albumin Solution | Number of Participants Needing Renal Replacement | 1 Participants |
| Intravenous Balanced Crystalloid | Number of Participants Needing Renal Replacement | 2 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5% Human Albumin Solution | Number of Patients Developing Acute Kidney Injury (AKI) | 36 Participants |
| Intravenous Balanced Crystalloid | Number of Patients Developing Acute Kidney Injury (AKI) | 30 Participants |
Secondary
Number of Patients Developing Allergy or Anaphylaxis
Requirement for rescue management (antihistamines, adrenaline, intravenous fluids, steroid)
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5% Human Albumin Solution | Number of Patients Developing Allergy or Anaphylaxis | 0 Participants |
| Intravenous Balanced Crystalloid | Number of Patients Developing Allergy or Anaphylaxis | 1 Participants |
Secondary
Number of Patients Developing Pulmonary Oedema
Safety Radiology diagnosis or requirement for rescue management (new diuretic use)
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5% Human Albumin Solution | Number of Patients Developing Pulmonary Oedema | 22 Participants |
| Intravenous Balanced Crystalloid | Number of Patients Developing Pulmonary Oedema | 11 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5% Human Albumin Solution | Number of Patients Readmitted in First 90 Days After Discharge | 20 Participants |
| Intravenous Balanced Crystalloid | Number of Patients Readmitted in First 90 Days After Discharge | 21 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5% Human Albumin Solution | Number of Patients Who Receive Any Other Fluid Apart From Intervention or Control in First 6 Hrs After Recruitment | 33 Participants |
| Intravenous Balanced Crystalloid | Number of Patients Who Receive Any Other Fluid Apart From Intervention or Control in First 6 Hrs After Recruitment | 1 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5% Human Albumin Solution | Proportion of Patients Admitted to Critical Care (HDU/ICU) | 6 Participants |
| Intravenous Balanced Crystalloid | Proportion of Patients Admitted to Critical Care (HDU/ICU) | 3 Participants |
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.
Time frame: 30 days
Secondary
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 5% Human Albumin Solution | Time to Start of In-hospital Intravenous Fluids | 41 minutes |
| Intravenous Balanced Crystalloid | Time to Start of In-hospital Intravenous Fluids | 36 minutes |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5% Human Albumin Solution | Volume of Randomised Fluid Delivered in Each Arm in the First 24hrs | 1012 ml | Standard Deviation 703 |
| Intravenous Balanced Crystalloid | Volume of Randomised Fluid Delivered in Each Arm in the First 24hrs | 2209 ml | Standard Deviation 1461 |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 5% Human Albumin Solution | Volume of Randomised Fluid Delivered in Each Arm in the First 6hrs | 750 ml |
| Intravenous Balanced Crystalloid | Volume of Randomised Fluid Delivered in Each Arm in the First 6hrs | 1250 ml |
Secondary
Withdrawal From Study
Feasibility Outcomes assessing the number of participants who withdraw from study intervention and/or data collection
Time frame: Approx 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5% Human Albumin Solution | Withdrawal From Study | 3 Participants |
| Intravenous Balanced Crystalloid | Withdrawal From Study | 1 Participants |