Sodium chloride or Plasmalyte-148 evaluation in severe diabetic ketoacidosis (SCOPE-DKA): a cluster, crossover, randomized, controlled trial.
Critical care
Diabetes
Diabetic ketoacidosis
Fluid therapy
Plasmalyte-148
Sodium chloride
Journal
Intensive care medicine
ISSN: 1432-1238
Titre abrégé: Intensive Care Med
Pays: United States
ID NLM: 7704851
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
received:
09
05
2021
accepted:
09
07
2021
pubmed:
6
10
2021
medline:
16
11
2021
entrez:
5
10
2021
Statut:
ppublish
Résumé
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. 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 to ≥ - 3 mEq/L at 48 h. 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. 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.
Identifiants
pubmed: 34609547
doi: 10.1007/s00134-021-06480-5
pii: 10.1007/s00134-021-06480-5
doi:
Substances chimiques
Saline Solution
0
Sodium Chloride
451W47IQ8X
Banques de données
ANZCTR
['12618001622291']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1248-1257Investigateurs
Mark Scott
(M)
Stacey Watts
(S)
Timothy Harding
(T)
Steven Tyler
(S)
Bauke Hovinga
(B)
Tracy Joy Hess
(TJ)
Rajbir Sing Sandha
(RS)
David Austin
(D)
Syed Giasuddin Khadri
(SG)
Salomon Jacobus Poggenpoel
(SJ)
Helen Miles
(H)
Jane Brailsford
(J)
Teena Maguire
(T)
Kym Roberts
(K)
Ogilvie Thom
(O)
Isuru Seneviratne
(I)
David Stewart
(D)
Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.
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