You searched for:"Maurizio Cecconi"
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Original Article
Statistical analysis plan for early goal-directed therapy using a physiological holistic view – the ANDROMEDA-SHOCK: a randomized controlled trial
Rev Bras Ter Intensiva. 2018;30(3):253-263
Abstract
Original ArticleStatistical analysis plan for early goal-directed therapy using a physiological holistic view – the ANDROMEDA-SHOCK: a randomized controlled trial
Rev Bras Ter Intensiva. 2018;30(3):253-263
DOI 10.5935/0103-507X.20180041
Views0See moreABSTRACT
Background:
ANDROMEDA-SHOCK is an international, multicenter, randomized controlled trial comparing peripheral perfusion-targeted resuscitation to lactate-targeted resuscitation in patients with septic shock in order to test the hypothesis that resuscitation targeting peripheral perfusion will be associated with lower morbidity and mortality.
Objective:
To report the statistical analysis plan for the ANDROMEDA-SHOCK trial.
Methods:
We describe the trial design, primary and secondary objectives, patients, methods of randomization, interventions, outcomes, and sample size. We describe our planned statistical analysis for the primary, secondary and tertiary outcomes. We also describe the subgroup and sensitivity analyses. Finally, we provide details for presenting our results, including mock tables showing baseline characteristics, the evolution of hemodynamic and perfusion variables, and the effects of treatments on outcomes.
Conclusion:
According to the best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and initiating the analyses. We anticipate that this procedure will prevent analysis bias and enhance the utility of the reported results.
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Review Article
Hemodynamic optimization in severe trauma: a systematic review and meta-analysis
Rev Bras Ter Intensiva. 2014;26(4):397-406
Abstract
Review ArticleHemodynamic optimization in severe trauma: a systematic review and meta-analysis
Rev Bras Ter Intensiva. 2014;26(4):397-406
DOI 10.5935/0103-507X.20140061
Views0Objective:
Severe trauma can be associated with significant hemorrhagic shock and impaired organ perfusion. We hypothesized that goal-directed therapy would confer morbidity and mortality benefits in major trauma.
Methods:
The MedLine, Embase and Cochrane Controlled Clinical Trials Register databases were systematically searched for randomized, controlled trials of goal-directed therapy in severe trauma patients. Mortality was the primary outcome of this review. Secondary outcomes included complication rates, length of hospital and intensive care unit stay, and the volume of fluid and blood administered. Meta-analysis was performed using RevMan software, and the data presented are as odds ratios for dichotomous outcomes and as mean differences (MDs) and standard MDs for continuous outcomes.
Results:
Four randomized, controlled trials including 419 patients were analyzed. Mortality risk was significantly reduced in goal-directed therapy-treated patients, compared to the control group (OR=0.56, 95%CI: 0.34-0.92). Intensive care (MD: 3.7 days 95%CI: 1.06-6.5) and hospital length of stay (MD: 3.5 days, 95%CI: 2.75-4.25) were significantly shorter in the protocol group patients. There were no differences in reported total fluid volume or blood transfusions administered. Heterogeneity in reporting among the studies prevented quantitative analysis of complications.
Conclusion:
Following severe trauma, early goal-directed therapy was associated with lower mortality and shorter durations of intensive care unit and hospital stays. The findings of this analysis should be interpreted with caution due to the presence of significant heterogeneity and the small number of the randomized, controlled trials included.
Keywords:Fluid therapy/methodsHemodynamics/physiologyShock, hemorrhagicTrauma severity indicesWound and injuriesSee more
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Case reports Child Coronavirus infections COVID-19 Critical care Critical illness Extracorporeal membrane oxygenation Infant, newborn Intensive care Intensive care units Intensive care units, pediatric mechanical ventilation Mortality Physical therapy modalities Prognosis Respiration, artificial Respiratory insufficiency risk factors SARS-CoV-2 Sepsis