Albumin versus Balanced Crystalloid for the early resuscitation of sepsis: a randomised feasibility trial. The ABC-Sepsis Trial.

Abstract

Abstract Purpose International guidelines recommend intravenous crystalloid as the primary fluid for sepsis resuscitation, with 5% human albumin solution (HAS) as second line. However, it is unclear which fluid has superior clinical effectiveness. We conducted a feasibility trial comparing 5% HAS with balanced crystalloid in the early resuscitation of adults with sepsis in UK Emergency Departments (EDs), to investigate recruitment metrics and determine clinical event rates to inform subsequent trial design. Methods Multicentre, open, parallel-group randomised feasibility trial of adults with sepsis and a NEWS2 ≥ 5 who required intravenous fluids within one hour of randomisation. Main outcomes were recruitment rate and 30-day mortality. Measurements and Main Results: We recruited, as planned, 300 participants over 12 months. Mean (standard deviation) age was 69 (± 16) years, and 151 (50%) were male. From 1303 participants; 502 participants were potentially eligible and 300 randomised and received trial intervention. The median number of participants per site was 19 (range 1 to 63); 2.4 participants per site per month. 30-day mortality was 17.9% (n = 53). 31 (21.1%) participants died within 30-days in the 5% HAS arm, compared with 22 (14.8%) participants in the crystalloid arm; adjusted odds ratio 1.50 (95% confidence intervals; 0.84 to 2.83). Conclusions The ABC-Sepsis trial demonstrated the feasibility to recruit to a multicentre fluid resuscitation trial in UK EDs with recruitment on target and > 95% of participants receiving the intervention. There was separation in 30-day mortality outcome between arms with balanced crystalloid arm having a non-significantly lower mortality. The reasons for this are unclear.