Crit Care Resusc
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Randomized Controlled Trial Multicenter Study
A cluster randomised, crossover, registry-embedded clinical trial of proton pump inhibitors versus histamine-2 receptor blockers for ulcer prophylaxis therapy in the intensive care unit (PEPTIC study): study protocol.
The balance of risks and benefits with using proton pump inhibitors (PPIs) versus histamine-2 receptor blockers (H2RB) for stress ulcer prophylaxis in patients who are invasively ventilated in the intensive care unit (ICU) is uncertain. ⋯ The PEPTIC study will compare the effect on in-hospital mortality of implementing, at the level of the ICU, the use of PPI as the preferred agent for stress ulcer prophylaxis in mechanically ventilated adults in the ICU with using H2RB as the preferred agent.
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Randomized Controlled Trial Multicenter Study
Design and statistical analysis plan for a trial comparing a conservative fluid management strategy with usual care in patients after cardiac surgery: the FAB study.
Cardiac surgery is one of the most frequently performed major surgical procedures. Following surgery, haemodynamic instability and prevention of organ dysfunction may be treated in the intensive care unit (ICU) with intravenous fluid, inotropes and vasopressors. In other surgical groups, liberal intravenous fluid administration and a positive fluid balance have been associated with adverse outcomes and increased risk of morbidity and mortality. There is a paucity of evidence to guide intravenous fluid administration in cardiac surgery patients. We have previously shown that a protocol-guided strategy avoiding unnecessary fluid administration significantly reduces fluid loading. ⋯ This trial aims to determine whether a protocol-guided strategy that avoids unnecessary fluid administration reduces ICU length of stay and improves outcomes in higher-risk adults undergoing cardiac surgery.
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Randomized Controlled Trial Multicenter Study Comparative Study
Permissive Hypercapnia, Alveolar Recruitment and Low Airway Pressure (PHARLAP): a protocol for a phase 2 trial in patients with acute respiratory distress syndrome.
Mechanical ventilation is a life-saving intervention that maintains gas exchange in patients with acute respiratory distress syndrome (ARDS); however, it is associated with high mortality and it may augment, or even initiate, lung injury. An open lung ventilation strategy that combines alveolar recruitment manoeuvres with individually titrated positive end-expiratory pressure (PEEP) and targeting lower tidal volumes, or driving pressures by a permissive approach to hypercapnia, may reduce the lung injury associated with mechanical ventilation. This protocol reports the rationale, study design and analysis plan of the Permissive Hypercapnia, Alveolar Recruitment and Low Airway Pressure (PHARLAP) trial. ⋯ The PHARLAP trial will determine whether the intervention strategy is effective in increasing ventilator-free days in patients with ARDS. If the PHARLAP strategy is proven to improve ventilator-free days, it will provide a strong impetus to conduct an international phase 3 trial to determine the effects of this strategy on mortality.
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Multicenter Study Observational Study
Ventilation management in Victorian intensive care unit patients without acute respiratory distress syndrome.
The setting of tidal volume (VT) during controlled mechanical ventilation (CMV) in critically ill patients without acute respiratory distress syndrome (ARDS) is likely important but currently unknown. We aimed to describe current CMV settings in intensive care units (ICUs) across Victoria. ⋯ In adults without ARDS undergoing CMV in Australian ICUs, the initial VT was a stereotypical 500 mL in one-third of participants, irrespective of sex. Moreover, around 40% of patients were exposed to an initial VT-PBW > 8.0 mL/kg. Finally, women were more likely to be exposed to a high VT and hyperventilation.
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Randomized Controlled Trial Multicenter Study
Study protocol for the Augmented versus Routine Approach to Giving Energy Trial (TARGET).
Nutrition is routinely provided to critically ill patients who are mechanically ventilated and remain in the intensive care unit for more than a few days. Nasogastric feeding, which is standard practice for patients who are unable to tolerate oral nutrition, typically delivers less than 60% of the recommended energy requirements. It remains uncertain whether the delivery of about 100% of the recommended energy goals via the enteral route will affect survival and other important clinical outcomes. ⋯ The results of this trial are expected to determine whether increased energy delivery, using an energy-dense formula can improve clinically meaningful outcomes, including survival.