Albumin Versus Balanced Crystalloid for the Early Resuscitation of Sepsis: An Open Parallel-Group Randomized Feasibility Trial- The ABC-Sepsis Trial.
Crit Care Med
; 52(10): 1520-1532, 2024 Oct 01.
Article
in En
| MEDLINE
| ID: mdl-38912884
ABSTRACT
OBJECTIVES:
International guidelines recommend IV crystalloid as the primary fluid for sepsis resuscitation, with 5% human albumin solution (HAS) as the second line. However, it is unclear which fluid has superior clinical effectiveness. We conducted a trial to assess the feasibility of delivering a randomized controlled trial comparing balanced crystalloid against 5% HAS as sole early resuscitation fluid in patients with sepsis presenting to hospital.DESIGN:
Multicenter, open, parallel-group randomized feasibility trial.SETTING:
Emergency departments (EDs) in 15 U.K. National Health Service (NHS) hospitals. PATIENTS Adult patients with sepsis and a National Early Warning Score 2 greater than or equal to five requiring IV fluids withing one hour of randomization.INTERVENTIONS:
IV fluid resuscitation with balanced crystalloid or 5% HAS for the first 6 hours following randomization. MEASUREMENTS AND MAINRESULTS:
Primary feasibility outcomes were recruitment rate and 30-day mortality. We successfully recruited 301 participants over 12 months. Mean ( sd ) age was 69 years (± 16 yr), and 151 (50%) were male. From 1303 participants screened; 502 participants were potentially eligible and 300 randomized to receive trial intervention with greater than 95% of participants receiving the intervention. The median number of participants per site was 19 (range, 1-63). Thirty-day mortality was 17.9% ( n = 53). Thirty-one participants died (21.1%) within 30 days in the 5% HAS arm, compared with 22 participants (14.8%) in the crystalloid arm (adjusted odds ratio, 1.50; 95% CIs, 0.84-2.83).CONCLUSIONS:
Our results suggest it is feasible to recruit critically ill patients to a fluid resuscitation trial in U.K. EDs using 5% HAS as a primary resuscitation fluid. There was lower mortality in the balanced crystalloid arm. Given these findings, a definitive trial is likely to be deliverable, but the point estimates suggest such a trial would be unlikely to demonstrate a significant benefit from using 5% HAS as a primary resuscitation fluid in sepsis.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Resuscitation
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Feasibility Studies
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Sepsis
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Albumins
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Fluid Therapy
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Crystalloid Solutions
Limits:
Aged
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Aged80
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Female
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Humans
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Male
/
Middle aged
Language:
En
Journal:
Crit Care Med
Year:
2024
Type:
Article
Affiliation country:
United kingdom