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Phase 3 N=300 Randomized Treatment

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

Sepsis

Enrolled (actual)
300
Serious AEs
2.3%
Results posted
Oct 2024
Primary outcome: Primary: Recruitment Rate — 150; 150 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Human albumin (Drug); Balanced crystalloid solution (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Edinburgh
Primary completion
Sep 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Recruitment Rate
150; 150
PRIMARY
30-day Mortality
31; 22
SECONDARY
Data Completeness of Primary Outcome
147; 149
SECONDARY
Withdrawal From Study
3; 1
SECONDARY
Number of Patients Who Receive Any Other Fluid Apart From Intervention or Control in First 6 Hrs After Recruitment
33; 1
SECONDARY
Time to Start of In-hospital Intravenous Fluids
41; 36
SECONDARY
In-hospital Mortality
29; 23
SECONDARY
90-day Mortality
43; 32
SECONDARY
Volume of Randomised Fluid Delivered in Each Arm in the First 6hrs
750; 1250
SECONDARY
Length of Hospital Stay
12.7; 13.9
SECONDARY
Proportion of Patients Admitted to Critical Care (HDU/ICU)
6; 3
SECONDARY
Length of Stay in Critical Care (HDU/ICU)
1.3; 1.5
SECONDARY
Number of Participants Needing Intravenous Vasopressors
18; 12
SECONDARY
Number of Participants Needing Renal Replacement
1; 2
SECONDARY
Number of Participants Needing Invasive Ventilation
7; 4
SECONDARY
Number of Patients Readmitted in First 90 Days After Discharge
20; 21
SECONDARY
Number of Patients Developing Acute Kidney Injury (AKI)
36; 30
SECONDARY
Number of Patients Developing Pulmonary Oedema
22; 11
SECONDARY
Number of Patients Developing Allergy or Anaphylaxis
0; 1
SECONDARY
Health Related Quality of Life (EQ-5D-5L Questionnaire)
0.4; 0.5
SECONDARY
Secondary Care Costs
SECONDARY
Volume of Randomised Fluid Delivered in Each Arm in the First 24hrs
1012; 2209
SECONDARY
Health Related Quality of Life (EQ-5D-5L Questionnaire)
0.4; 0.5
SECONDARY
Health Related Quality of Life (EQ-5D-5L Questionnaire)
0.4; 0.5

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.

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:

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04540094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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