Phase 3
N=300
Feasibility of 5% Albumin Compared With Balanced Crystalloid, as Intravenous Fluid Resuscitation in Adult Patients With Sepsis, Presenting as an Emergency to Hospital
Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT04540094 ↗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
| Outcome | Result | p-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.
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.