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Special Article
Dapagliflozin in patients with critical illness: rationale and design of the DEFENDER study
Crit Care Sci. 2023;35(3):256-265
Abstract
Special ArticleDapagliflozin in patients with critical illness: rationale and design of the DEFENDER study
Crit Care Sci. 2023;35(3):256-265
DOI 10.5935/2965-2774.20230129-pt
Views9ABSTRACT
Background:
Critical illness is a major ongoing health care burden worldwide and is associated with high mortality rates. Sodium-glucose cotransporter-2 inhibitors have consistently shown benefits in cardiovascular and renal outcomes. The effects of sodium-glucose cotransporter-2 inhibitors in acute illness have not been properly investigated.
Methods:
DEFENDER is an investigator-initiated, multicenter, randomized, open-label trial designed to evaluate the efficacy and safety of dapagliflozin in 500 adult participants with acute organ dysfunction who are hospitalized in the intensive care unit. Eligible participants will be randomized 1:1 to receive dapagliflozin 10mg plus standard of care for up to 14 days or standard of care alone. The primary outcome is a hierarchical composite of hospital mortality, initiation of kidney replacement therapy, and intensive care unit length of stay, up to 28 days. Safety will be strictly monitored throughout the study.
Conclusion:
DEFENDER is the first study designed to investigate the use of a sodium-glucose cotransporter-2 inhibitor in general intensive care unit patients with acute organ dysfunction. It will provide relevant information on the use of drugs of this promising class in critically ill patients.
ClinicalTrials.gov registry:
NCT05558098
Keywords:Critical care outcomesCritical illnessOrgan dysfunctionSodium-glucose transporter 2 inhibitorsSee more -
Original Article
Effects of balanced solution on short-term outcomes in traumatic brain injury patients: a secondary analysis of the BaSICS randomized trial
Rev Bras Ter Intensiva. 2022;34(4):410-417
Abstract
Original ArticleEffects of balanced solution on short-term outcomes in traumatic brain injury patients: a secondary analysis of the BaSICS randomized trial
Rev Bras Ter Intensiva. 2022;34(4):410-417
DOI 10.5935/0103-507X.20220261-en
Views2ABSTRACT
Objective:
To describe the effects of balanced solution use on the short-term outcomes of patients with traumatic brain injury enrolled in BaSICS trial.
Methods:
Patients were randomized to receive either 0.9% saline or balanced solution during their intensive care unit stay. The primary endpoint was 90-day mortality, and the secondary outcomes were days alive and free of intensive care unit stay at 28 days. The primary endpoint was assessed using Bayesian logistic regression. The secondary endpoint was assessed using a Bayesian zero-inflated beta binomial regression.
Results:
We included 483 patients (236 in the 0.9% saline arm and 247 in the balanced solution arm). A total of 338 patients (70%) with a Glasgow coma scale score ≤ 12 were enrolled. The overall probability that balanced solutions were associated with higher 90-day mortality was 0.98 (OR 1.48; 95%CrI 1.04 – 2.09); this mortality increment was particularly noticeable in patients with a Glasgow coma scale score below 6 at enrollment (probability of harm of 0.99). Balanced solutions were associated with -1.64 days alive and free of intensive care unit at 28 days (95%CrI -3.32 – 0.00) with a probability of harm of 0.97.
Conclusion:
There was a high probability that balanced solutions were associated with high 90-day mortality and fewer days alive and free of intensive care units at 28 days.
Keywords:Balanced solutionsBrain injuriesCritical careHospital mortalityMortalitySaline solutiontraumaticSee more -
Commentaries
Optimizing perioperative mechanical ventilation as a key quality improvement target
Rev Bras Ter Intensiva. 2015;27(2):102-104
Abstract
CommentariesOptimizing perioperative mechanical ventilation as a key quality improvement target
Rev Bras Ter Intensiva. 2015;27(2):102-104
DOI 10.5935/0103-507X.20150019
Views0BACKGROUNDThe occurrence of postoperative pulmonary complications is strongly associated with increased hospital mortality and prolonged postoperative hospital stay.(,) Postoperative pulmonary complications could, at least in part be prevented by using so-called lung protective mechanical ventilation strategies, which may include use of low tidal volume (VT), positive end-expiratory pressure (PEEP) and low oxygen fractions (FiO2).()[…]See more
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