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Completed

NCT Number: NCT04540094

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

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aberdeen Royal Infirmary, Aberdeen, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients (18 years or older) who present to UK NHS hospitals with community acquired sepsis meeting all of the 4 criteria:

  • Clinically suspected or proven infection resulting in principal reason for acute illness;
  • NEWS score ≥5 (or NEWS2 if adopted in recruitment site);
  • Hospital presentation within last 12hrs; and
  • Clinician decision has been made that immediate (within 1 hour) intravenous fluid resuscitation is needed.

Exclusion criteria

  • >1 litre of intravenous crystalloid fluid or any intravenous HAS administered prior to eligibility assessment;
  • Requirement for immediate surgery (within one hour of eligibility assessment);
  • Chronic renal replacement therapy;
  • Known allergy/adverse reaction to HAS;
  • Balanced crystalloid or HAS not available;
  • Known adverse reaction to blood products;
  • 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);
  • Religious beliefs precluding HAS administration;
  • Previous recruitment in the trial;
  • Known recent severe traumatic brain injury (within 3 months);
  • Patients with permanent incapacity;
  • Known recruitment in another CTIMP studies within the last 30 days where co-enrolment has not been agreed.

Treatment and study plan

Human albumin

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

Balanced crystalloid solution

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.

Primary outcomes

  1. Recruitment Rate

    Time frame: 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.

  2. 30-day Mortality

    Time frame: 30 days

    Assessment of how many participants in each arm died after 30 days to determine the effect size between the treatment groups.

Secondary outcomes

  1. Data Completeness of Primary Outcome

    Time frame: 180 days

    Feasibility Outcome assessing the number of participants who provided data for clinical primary outcome (30 day mortality)

  2. Withdrawal From Study

    Time frame: Approx 1 year

    Feasibility Outcomes assessing the number of participants who withdraw from study intervention and/or data collection

  3. Number of Patients Who Receive Any Other Fluid Apart From Intervention or Control in First 6 Hrs After Recruitment

    Time frame: 6 hours

    Feasibility Outcome- number of patients who receive any other fluid apart from intervention or control in first 6 hrs after recruitment

  4. Time to Start of In-hospital Intravenous Fluids

    Time frame: From time of Randomisation until fluid first being administered measured up to 6 hours.

    Feasibility Outcome- Time to start of in-hospital intravenous fluids

  5. In-hospital Mortality

    Time frame: From time of Randomisation until time of hospital discharge or death, whichever is first measured up to 90 days

    Secondary Clinical Outcome

  6. 90-day Mortality

    Time frame: 90 days

    Secondary Clinical Outcome

  7. Volume of Randomised Fluid Delivered in Each Arm in the First 6hrs

    Time frame: 6 hours

    Secondary Clinical Outcome- Volume of randomised fluid delivered in each arm in the first 6hrs

  8. Length of Hospital Stay

    Time frame: 90 days

    Secondary Clinical Outcome

  9. Proportion of Patients Admitted to Critical Care (HDU/ICU)

    Time frame: 90 days

    Secondary Clinical Outcome- Proportion of patients admitted to critical care (HDU/ICU)

  10. Length of Stay in Critical Care (HDU/ICU)

    Time frame: 90 days

    Secondary Clinical Outcome- Length of stay in critical care (HDU/ICU)

  11. Number of Participants Needing Intravenous Vasopressors

    Time frame: From time of Randomisation until time of hospital discharge, measured up to 90 days.

    Secondary Clinical Outcome-number of participants needing intravenous vasopressors

  12. Number of Participants Needing Renal Replacement

    Time frame: From time of Randomisation until time of hospital discharge, measured up to 90 days.

    Secondary Clinical Outcome- Number of participants needing renal replacement

  13. Number of Participants Needing Invasive Ventilation

    Time frame: From time of Randomisation until time of hospital discharge, measured up to 90 days.

    Secondary Clinical Outcome- Number of participants needing invasive ventilation

  14. Number of Patients Readmitted in First 90 Days After Discharge

    Time frame: 90 days

    Secondary Clinical Outcome- Number of patients readmitted in first 90 days after discharge

  15. Number of Patients Developing Acute Kidney Injury (AKI)

    Time frame: 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.

  16. Number of Patients Developing Pulmonary Oedema

    Time frame: 7 days

    Safety Radiology diagnosis or requirement for rescue management (new diuretic use)

  17. Number of Patients Developing Allergy or Anaphylaxis

    Time frame: 7 days

    Requirement for rescue management (antihistamines, adrenaline, intravenous fluids, steroid)

  18. Health Related Quality of Life (EQ-5D-5L Questionnaire)

    Time frame: 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.

  19. Secondary Care Costs

    Time frame: 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.

  20. Volume of Randomised Fluid Delivered in Each Arm in the First 24hrs

    Time frame: 24 hours

    Secondary Clinical Outcome-Volume of randomised fluid delivered in each arm in the first 24hrs

  21. Health Related Quality of Life (EQ-5D-5L Questionnaire)

    Time frame: 7 Days

    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.

  22. Health Related Quality of Life (EQ-5D-5L Questionnaire)

    Time frame: 180 Days

    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.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study 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

Acronym: ABC Sepsis

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 7, 2020
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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