You searched for:"Glenn Hernández"
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Special Article
Hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial study protocol
- Eduardo Kattan
, - Jan Bakker ,
- Elisa Estenssoro ,
- Gustavo Adolfo Ospina-Tascón ,
- Alexandre Biasi Cavalcanti , [ … ],
- Glenn Hernández
Abstract
Special ArticleHemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial study protocol
Rev Bras Ter Intensiva. 2022;34(1):96-106
DOI 10.5935/0103-507X.20220004-en
- Eduardo Kattan ,
- Jan Bakker ,
- Elisa Estenssoro ,
- Gustavo Adolfo Ospina-Tascón ,
- Alexandre Biasi Cavalcanti ,
- Daniel De Backer ,
- Antoine Vieillard-Baron ,
- Jean-Louis Teboul ,
- Ricardo Castro ,
- Glenn Hernández
Views5ABSTRACT
Background:
Early reversion of sepsis-induced tissue hypoperfusion is essential for survival in septic shock. However, consensus regarding the best initial resuscitation strategy is lacking given that interventions designed for the entire population with septic shock might produce unnecessary fluid administration. This article reports the rationale, study design and analysis plan of the ANDROMEDA-2 study, which aims to determine whether a peripheral perfusion-guided strategy consisting of capillary refill time-targeted resuscitation based on clinical and hemodynamic phenotypes is associated with a decrease in a composite outcome of mortality, time to organ support cessation, and hospital length of stay compared to standard care in patients with early (< 4 hours of diagnosis) septic shock.
Methods:
The ANDROMEDA-2 study is a multicenter, multinational randomized controlled trial. In the intervention group, capillary refill time will be measured hourly for 6 hours. If abnormal, patients will enter an algorithm starting with pulse pressure assessment. Patients with pulse pressure less than 40mmHg will be tested for fluid responsiveness and receive fluids accordingly. In patients with pulse pressure > 40mmHg, norepinephrine will be titrated to maintain diastolic arterial pressure > 50mmHg. Patients who fail to normalize capillary refill time after the previous steps will be subjected to critical care echocardiography for cardiac dysfunction evaluation and subsequent management. Finally, vasopressor and inodilator tests will be performed to further optimize perfusion. A sample size of 1,500 patients will provide 88% power to demonstrate superiority of the capillary refill time-targeted strategy.
Conclusions:
If hemodynamic phenotype-based, capillary refill time-targeted resuscitation demonstrates to be a superior strategy, care processes in septic shock resuscitation can be optimized with bedside tools.
Keywords:AlgorithmCapillary refill timeCritical careEchocardiographyLength of staynorepinephrinePerfusionPhenotypeSepsisSeptic shockSee moreViews5
Abstract
Special ArticleHemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial study protocol
Rev Bras Ter Intensiva. 2022;34(1):96-106
DOI 10.5935/0103-507X.20220004-en
- Eduardo Kattan ,
- Jan Bakker ,
- Elisa Estenssoro ,
- Gustavo Adolfo Ospina-Tascón ,
- Alexandre Biasi Cavalcanti ,
- Daniel De Backer ,
- Antoine Vieillard-Baron ,
- Jean-Louis Teboul ,
- Ricardo Castro ,
- Glenn Hernández
Views5ABSTRACT
Background:
Early reversion of sepsis-induced tissue hypoperfusion is essential for survival in septic shock. However, consensus regarding the best initial resuscitation strategy is lacking given that interventions designed for the entire population with septic shock might produce unnecessary fluid administration. This article reports the rationale, study design and analysis plan of the ANDROMEDA-2 study, which aims to determine whether a peripheral perfusion-guided strategy consisting of capillary refill time-targeted resuscitation based on clinical and hemodynamic phenotypes is associated with a decrease in a composite outcome of mortality, time to organ support cessation, and hospital length of stay compared to standard care in patients with early (< 4 hours of diagnosis) septic shock.
Methods:
The ANDROMEDA-2 study is a multicenter, multinational randomized controlled trial. In the intervention group, capillary refill time will be measured hourly for 6 hours. If abnormal, patients will enter an algorithm starting with pulse pressure assessment. Patients with pulse pressure less than 40mmHg will be tested for fluid responsiveness and receive fluids accordingly. In patients with pulse pressure > 40mmHg, norepinephrine will be titrated to maintain diastolic arterial pressure > 50mmHg. Patients who fail to normalize capillary refill time after the previous steps will be subjected to critical care echocardiography for cardiac dysfunction evaluation and subsequent management. Finally, vasopressor and inodilator tests will be performed to further optimize perfusion. A sample size of 1,500 patients will provide 88% power to demonstrate superiority of the capillary refill time-targeted strategy.
Conclusions:
If hemodynamic phenotype-based, capillary refill time-targeted resuscitation demonstrates to be a superior strategy, care processes in septic shock resuscitation can be optimized with bedside tools.
Keywords:AlgorithmCapillary refill timeCritical careEchocardiographyLength of staynorepinephrinePerfusionPhenotypeSepsisSeptic shockSee more
- Eduardo Kattan
-
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.
Views0Abstract
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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Original Articles – Clinical Research
Positive end-expiratory pressure increases strain in patients with ALI/ARDS
Rev Bras Ter Intensiva. 2012;24(1):43-51
Abstract
Original Articles – Clinical ResearchPositive end-expiratory pressure increases strain in patients with ALI/ARDS
Rev Bras Ter Intensiva. 2012;24(1):43-51
DOI 10.1590/S0103-507X2012000100007
Views0OBJECTIVE: The objective of this study was to assess the effects of positive end-expiratory pressure on recruitment, cyclic recruitment and derecruitment and strain in patients with acute lung injury and acute respiratory distress syndrome using lung computed tomography. METHODS: This is an open, controlled, non-randomized interventional study of ten patients with acute lung injury and acute respiratory distress syndrome. Using computed tomography, single, basal slices of the lung were obtained during inspiratory and expiratory pauses at a tidal volume of 6 ml/kg and a positive end-expiratory pressure of 5, 10, 15 and 20 cmH2O. The densities of the lung parenchyma were measured in Hounsfield units. The values for positive end-expiratory pressure-induced recruitment, cyclic recruitment and derecruitment and strain were then calculated. RESULTS: Increasing levels of positive end-expiratory pressure were correlated with increased recruitment and global strain (p < 0.01), which was significantly correlated with plateau pressure (r² = 0.97, p < 0.01). In addition, increasing levels of positive end-expiratory pressure systematically increased strain along the sternovertebral axis. CONCLUSION: While strain is an adverse effect of positive end-expiratory pressure, the decision use positive end-expiratory pressure with any patient should be balanced against the potential benefits of recruitment. Due to the small number of patients in this study, the present data should be treated as hypothesis generating and is not intended to limit the clinical application of a high level of positive end-expiratory pressure in patients with severe hypoxemia.
Keywords:Positive end-expiratory pressureRespiration, artificialRespiratory distress syndrome, adultTomography, X-ray computedSee moreViews0Abstract
Original Articles – Clinical ResearchPositive end-expiratory pressure increases strain in patients with ALI/ARDS
Rev Bras Ter Intensiva. 2012;24(1):43-51
DOI 10.1590/S0103-507X2012000100007
Views0OBJECTIVE: The objective of this study was to assess the effects of positive end-expiratory pressure on recruitment, cyclic recruitment and derecruitment and strain in patients with acute lung injury and acute respiratory distress syndrome using lung computed tomography. METHODS: This is an open, controlled, non-randomized interventional study of ten patients with acute lung injury and acute respiratory distress syndrome. Using computed tomography, single, basal slices of the lung were obtained during inspiratory and expiratory pauses at a tidal volume of 6 ml/kg and a positive end-expiratory pressure of 5, 10, 15 and 20 cmH2O. The densities of the lung parenchyma were measured in Hounsfield units. The values for positive end-expiratory pressure-induced recruitment, cyclic recruitment and derecruitment and strain were then calculated. RESULTS: Increasing levels of positive end-expiratory pressure were correlated with increased recruitment and global strain (p < 0.01), which was significantly correlated with plateau pressure (r² = 0.97, p < 0.01). In addition, increasing levels of positive end-expiratory pressure systematically increased strain along the sternovertebral axis. CONCLUSION: While strain is an adverse effect of positive end-expiratory pressure, the decision use positive end-expiratory pressure with any patient should be balanced against the potential benefits of recruitment. Due to the small number of patients in this study, the present data should be treated as hypothesis generating and is not intended to limit the clinical application of a high level of positive end-expiratory pressure in patients with severe hypoxemia.
Keywords:Positive end-expiratory pressureRespiration, artificialRespiratory distress syndrome, adultTomography, X-ray computedSee 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