Trial Files: Transfusion Targets in Brain Injury, Timing/Frequency of SBT, and Intermittent Fasting for CV Health
Restrictive vs Liberal Transfusion Strategy in Patients With Acute Brain Injury: The TRAIN Randomized Clinical Trial
Taccone F et al. JAMA (October 2024)
Bottom Line: This phase 3, parallel-group, investigator-initiated, pragmatic, open-label randomized clinical trial aimed to assess the impact of two different hemoglobin thresholds on neurological outcome in patients with acute brain injury. The study included 850 patients from 72 intensive care units across 22 countries who were randomized to undergo a liberal (transfusion triggered by hemoglobin < 9 g/dL; n = 408) or restrictive (transfusion triggered by hemoglobin < 7 g/dL; n = 442) transfusion strategy over a 28-day period. The primary outcome was occurrence of an unfavourable neurological outcome, defined as a Glasgow Outcome Scale Extended score between 1 and 5, at 180 days following randomization. Results showed that patients in the liberal transfusion strategy group had a significantly lower risk of unfavourable neurological outcome at 63.6%, compared to 72.6% in the restrictive strategy group (absolute difference, −10.0% [95% CI, −16.5% to −3.6%]; adjusted relative risk, 0.86 [95% CI, 0.79-0.94]; P = 0.002). Additionally, the liberal strategy group had a lower incidence of cerebral ischemic events (8.8% vs 13.5% in the restrictive strategy group; relative risk, 0.65 [95% CI, 0.44-0.97]). This study provides evidence for the use of a liberal transfusion strategy in patients with acute brain injury and anemia.
Frequency of Screening and Spontaneous Breathing Trial Techniques: A Randomized Clinical Trial
Burns L et al. JAMA (October 2024)
Bottom Line: This randomized clinical trial with a 2x2 factorial design aimed to compare the effects of screening frequency and spontaneous breathing trial (SBT) technique on the time to successful extubation. The study included critically ill adults receiving invasive mechanical ventilation for at least 24 hours who were capable of initiating spontaneous breaths or triggering ventilators and receiving an FiO2 of < 70% and positive end-expiratory pressure (PEEP) of 12 cm H2O or less. Screening frequency was either more frequent or once daily, while SBT technique was either pressure-supported with a pressure support level that was >0-≤8 cm H2O and a PEEP level that was >0-≤5 cm H2O or T-piece SBT lasting 30 to 120 minutes. The study included 797 patients and found no significant difference in time to successful extubation between the intervention group, which received early protocolized screening with more frequent screening and pressure-supported SBTs, and the comparator group, which received early protocolized screening with once-daily screening and T-piece SBTs. However, an unexpected interaction was identified, with more frequent screening and pressure-supported SBTs increasing the time to successful extubation (HR, 0.70 [95% CI, 0.50-0.96]; P = 0.02). This study highlights the need for further research in this area to determine the optimal screening frequency and SBT technique for successful extubation in critically ill adults.
Time-Restricted Eating in Adults With Metabolic Syndrome: A Randomized Controlled Trial
Manoogian E et al. Annals of Internal Medicine (October 2024)
Bottom line: This randomized controlled trial evaluated the effects of time-restricted eating (TRE) as a lifestyle intervention on cardiometabolic health in 108 adults with metabolic syndrome including elevated blood glucose or HbA1c. Participants were randomly assigned to receive either standard-of-care (SOC) nutritional counselling alone or combined with a personalized 8- to 10-hour TRE intervention for 3 months. The primary outcome, HbA1c, showed a modest improvement of -0.1% in the TRE group compared to the SOC group (95% CI, −0.19% to −0.003%). No major adverse events were reported. This study suggests that personalized 8- to 10-hour TRE may be an effective practical lifestyle intervention for improving glycemic regulation and potentially other cardiometabolic health markers in adults with metabolic syndrome.
Trial Files Issue #2024-23
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