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Randomized Controlled Trial
. 2024 Oct 1;52(10):1520-1532.
doi: 10.1097/CCM.0000000000006348. Epub 2024 Jun 24.

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

Alasdair J Gray  1   2 , Katherine Oatey  3 , Julia Grahamslaw  1 , Sîan Irvine  3 , John Cafferkey  1 , Titouan Kennel  3 , John Norrie  3 , Tim Walsh  2 , Nazir Lone  2 , Daniel Horner  4   5 , Andy Appelboam  6 , Peter Hall  3 , Richard J E Skipworth  7 , Derek Bell  8 , Kevin Rooney  9   10 , Manu Shankar-Hari  11 , Alasdair R Corfield  10   12 ; Albumin, Balanced, and Crystalloid-Sepsis (ABC-Sepsis) Investigators
Collaborators, Affiliations
Randomized Controlled Trial

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

Alasdair J Gray et al. Crit Care Med. .

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 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.

Trial registration: ClinicalTrials.gov NCT04540094.

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Conflict of interest statement

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.

References

    1. Rhodes A, Evans LE, Alhazzani W, et al.: Surviving sepsis campaign: International guidelines for management of sepsis and septic shock 2016. Intensive Care Med. 2017; 43:304–377
    1. Royal College of Physicians: National Early Warning Score (NEWS) 2: Standardising the Assessment of Acute Illness Severity in the NHS. Report of a Working Party. London, United Kingdom, Royal College of Physicians, 2017. Available at: https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-scor... . Accessed August 8, 2023
    1. Corfield AR, Lees F, Zealley I, et al.; Scottish Trauma Audit Group Sepsis Steering Group: Utility of a single early warning score in patients with sepsis in the emergency department. Emerg Med J. 2014; 31:482–487
    1. Golden H, Hoyle M, Monis J, et al.: qSOFA, SIRS and NEWS for predicting in hospital mortality and ICU admission in emergency admissions treated as sepsis. Emerg Med J. 2018; 35:345–349
    1. Fleischmann C, Scherag A, Adhikari NKJ, et al.; International Forum of Acute Care Trialists: Assessment of global incidence and mortality of hospital-treated sepsis. Current estimates and limitations. Am J Respir Crit Care Med. 2016; 193:259–272

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