Albumin Versus Balanced Crystalloid for the Early Resuscitation of Sepsis: An Open Parallel-Group Randomized Feasibility Trial- The ABC-Sepsis Trial.

Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 0355501 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1530-0293 (Electronic) Linking ISSN: 00903493 NLM ISO Abbreviation: Crit Care Med Subsets: MEDLINE

Publication: Philadelphia, PA : Lippincott Williams & Wilkins
Original Publication: New York, Kolen.

Crystalloid Solutions*/administration & dosage ; Crystalloid Solutions*/therapeutic use ; Sepsis*/therapy ; Sepsis*/mortality ; Feasibility Studies* ; Fluid Therapy*/methods ; Resuscitation*/methods ; Albumins*/therapeutic use ; Albumins*/administration & dosage; Humans ; Male ; Female ; Aged ; Middle Aged ; Aged, 80 and over

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 Main Results: 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.
Competing Interests: Dr. Bell is supported by the National Institute of Applied Research Collaboration Northwest London. Dr. Gray’s, Ms. Oatey’s, Dr. Irvine’s, Mr. Kennel’s, Dr. Norrie’s, Dr. Walsh’s, and Dr. Hall’s institutions received funding from the John Moulton Charitable Trust. Dr. Gray, Ms. Grahamslaw, and Dr. Appelboam received support for article research from the John Moulton Charitable Trust. Ms. Oatey disclosed work for hire. Dr. Cafferkey’s institution received funding from the Royal College of Emergency Medicine and the Sepsis FEAT Charity. Dr. Horner’s institution received funding from the National Institute for Health Research (132594). Mr. Skipworth received funding from Helsinn, Faraday Pharmaceuticals, Actimed Therapeutics, and Pfizer. The remaining authors have disclosed that they do not have any potential conflicts of interest.
(Copyright © 2024 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.)

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Investigator: V Newcombe; R Chapman; C Hutton; G Perkins; A Gordon; L Keating; P Pallmann; R Armstrong; R Pollock; T Wackett; R Chapman; C Hutton; J Kale; N Kale; R Anderson; D Birrell; P Black; C Blackstock; J Carter; D Clark; C Davidson; C Davie; ND Rollo; A Ferguson; N Fethers; N Freeman; L Gibson; A Grant; MC Harris; E James; K Letham; S Lynch; F McCurrach; S McKenzie; C McLaughlin; A Miell; L Moncur; R O'Brien; G Pickering; M Reed; R Rezai; S Robinson; J Skinner; C Walker; A Williams; EB Wilson; N Di Rollo; J Carruthers; C Cheyne; A McGeough; R Lidstone-Scott; S Lynch; L Abel; S Bongale; S Currie; D Kane; R Keen; I Orlikowska; N Rodden; J Tait; N Thomson; L Walker; K Smith; A Brown; S Cathcart; D Maguire; P O'Mailley; D Rimmer; C Ward; N Baxter; F Denny; K Doran; L Dunlop; J Dunn; L Finnen; D Green; E Hughes; D Lowe; C McArthur; B McLaren; K McLeish; L McMunigal; C McParland; O O'Shaughnessy; M Wilson; R Armes; C Brown; J Cooper; D Connor; O Collier-Wakefield; M Coutts; M Cruickshank; B Ebtehadj; P Ganley; J Hiscox; C Hartman; L Kane; S Kastora; S Lamb; S McCarthy; C Mulholland; I Nadim; J Noble; G Patton; D Savage; B Spowage-Delaney; R Doonan; S Lee; J Strange; F Barham; C Bosanko; R Bullough; J Danglosi; E Freeman; LA Jackson; R James; L Jose; F Lowe; A Lowther; I McCarthy; D McConnell; R Parry; H Shirreff; J Smith; R Squire; W Battishill; G Boggaram; G Chilcott; J Gagg; E Machin; C Shovelton; R Purnell; R Crosthwaite-Eyre; G Page; A Pitt; P Riou; D Sykes; C Worth; L Zitter; T Baron; D Baskaran; S Beer; A Bhargav; H Blamey; C Brown; B Clare-Gray; M Davies; N Dawson; K Dineen; I Edgar; V Erasu; M Faisal; D Georgiou; A Gibson; R Ghataoura; S Glover; O Gordon; S Ilyas; A Jeffs; H Knott; S Kundoor; J Martinez; A McCallum; A Novak; T Panduro; R Pattanshetty; I Paul; RR Magallano; P Razdan; T Sambo; S Shah; A Shaikh; S Smith; H Thraves; C Tickle; J Ang; A Boyle; S Hardwick; K Meynell; S Miller; J Charsley; S Jolly; F Mahony; J Moseley-Rodgers; N Sivayoham; T Sheerin; C Seel; M Abdalla; G Cameron; J Harnett; D Ramos; FS Perez; R White; W Abdullah; S Ballard; K Barnes; R Clegg; E Cousins; S Cumiskey; B Elwir; A Ferriman; A Fletcher; C Griffiths; P Guiling; G Johnson; B Loach; A Matthews; L May-Moulden; R Norman; H Seelly; R Smith; A Tabner; N Tilbury; T Ward; L Wright; H Wroblewski; M Zawadzka

ClinicalTrials.gov NCT04540094

0 (Crystalloid Solutions)
0 (Albumins)

Date Created: 20240624 Date Completed: 20240916 Latest Revision: 20240916

20240917

10.1097/CCM.0000000000006348

38912884