Sodium chloride or Plasmalyte-148 evaluation in severe diabetic ketoacidosis (SCOPE-DKA): a cluster, crossover, randomized, controlled trial.

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From: Intensive Care Medicine(Vol. 47, Issue 11)
Publisher: Springer
Document Type: Report
Length: 469 words

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Keywords: Diabetic ketoacidosis; Diabetes; Critical care; Fluid therapy; Plasmalyte-148; Sodium chloride Abstract Purpose To determine whether treatment with Plasmalyte-148 (PL) compared to sodium chloride 0.9% (SC) results in faster resolution of diabetic ketoacidosis (DKA) and whether the acetate in PL potentiates ketosis. Methods We conducted a cluster, crossover, open-label, randomized, controlled Phase 2 trial at seven hospitals in adults admitted to intensive care unit (ICU) with severe DKA with hospital randomised to PL or SC as fluid therapy. The primary outcome, DKA resolution, was defined as a change in base excess toâ¥-3 mEq/L at 48 h. Results Ninety-three patients were enrolled with 90 patients included in the modified-intention-to-treat population (PL n=48, SC n=42). At 48 h, mean fluid administration was 6798±4850 ml vs 6574±3123 ml, median anion gap 6 mEq/L (IQR 5--7) vs 7 mEq/L (IQR 5--7) and median blood ketones 0.3 mmol/L (IQR 0.1--0.5) vs 0.3 (IQR 0.1--0.5) in the PL and SC groups. DKA resolution at 48 h occurred in 96% (PL) and 86% (SC) of patients odds ratio 3.93 (95% CI 0.73--21.16, p=0.111). At 24 h, DKA resolution occurred in 69% (PL) and 36% (SC) of patients odds ratio 4.24 (95% CI 1.68--10.72, p=0.002). The median ICU and hospital lengths of stay were 49 h (IQR 23--72) vs 55 h (IQR 41--80) and 81 h (IQR 58--137) vs 98 h (IQR 65--195) in the PL and SC groups. Conclusion Plasmalyte-148, compared to sodium chloride 0.9%, may lead to faster resolution of metabolic acidosis in patients with DKA without an increase in ketosis. These findings need confirmation in a large, Phase 3 trial. Author Affiliation: (1) Intensive Care Unit, Caboolture Hospital, McKean Street, 4510, Caboolture, QLD, Australia (2) Adult Intensive Care Services, The Prince Charles Hospital, Rode Road, 4032, Chermside, QLD, Australia (3) The George Institute for Global Health, University of New South Wales, Level 5/1 King Street, 2042, Newtown, NSW, Australia (4) School of Medicine, University of Queensland, Sir Fred Schonell Drive, 4072, St Lucia, QLD, Australia (5) Intensive Care Unit, Rockhampton Hospital, Canning Street, 4700, Rockhampton, QLD, Australia (6) Intensive Care Unit, Sunshine Coast University Hospital, Doherty Street, 4575, Birtinya, QLD, Australia (7) Intensive Care Unit, Ipswich Hospital, Chelmsford Avenue, 4305, Ipswich, QLD, Australia (8) Intensive Care Unit, Queen Elizabeth-2 Jubilee Hospital, Kessels Road, 4108, Coopers Plains, QLD, Australia (9) Intensive Care Unit, Mackay Base Hospital, Bridge Road, 4741, Mackay, QLD, Australia (10) Intensive Care Unit, Hervey Bay Hospital, Urraween Road, 4655, Pialba, QLD, Australia (11) Intensive Care Unit, Princess Alexandra Hospital, Ipswich Road, 4102, Woolloongabba, QLD, Australia (12) Department of Intensive Care Medicine, The Queen Elizabeth Hospital, Woodville Road, 5011, Woodville South, South Australia, Australia (13) Intensive Care Unit, Wesley and Princess Alexandra Hospitals, Woolloongabba, QLD, Australia (a) Article History: Registration Date: 07/09/2021 Received Date: 05/09/2021 Accepted Date: 07/09/2021 Online Date: 10/05/2021 Byline:

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Gale Document Number: GALE|A680341460