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MoDUS - Modifying Delirium Using Simvastatin
This trial started in 2013 and is lead by Dr Valerie J. Page at Watford General Hospital, funded by the Research for Patients Benefit program from NIHR.
The incidence of delirium in mechanically ventilated patients can reach 80%. Delirium may predispose patients to long-term cognitive impairment after critical illness and is associated with inflammation and neuronal apoptosis, which may lead to brain atrophy. Therefore an intervention which reduces delirium could potentially translate to a reduction of long-term cognitive impairment and dementia.
A single centre, randomised, double-blind, placebo controlled, superiority, phase II trial, to recruit 142 patients randomised to receive once daily simvastatin 80mg placebo for up to 28 days. The aim of this study is to investigate the efficacy of statins initiated early during an ICU stay for the prevention of ICU delirium; to determine any improvement in related neurocognitive sequelae to reduce the incidence.
HOPE (HalOPeridol: Effectiveness trial)
Intravenous Haloperidol is the most commonly used therapy in critical care for the treatment of Delirium. 142 critical care patients were randomized to receive intravenous haloperidol v N saline to treat acute onset of delirium. Haloperidol did not reduce the duration of delirium in these patients compared with placebo.
This study has helped us to move onto other strategies which may prove more effective.
An exploration of social and economic outcome and associated health-related quality of life after critical illness in general intensive care unit survivors: a 12-month follow-up study.
ICON - Intensive Care Outcomes Network
This is a long-term study of patients who have spent at least 24 hours on an intensive care unit. The study was lead by principal investigator Dr Duncan Young from John Radcliffe Hospital Oxford.
It provides a comprehensive assessment of quality of life and psychological health for up to 2 years after discharge and describes the impact of an intensive care stay on development of stress related disorders, anxiety and depression. This has never previously been studied in such detail.
Overwhelming infection, often called sepsis, is a major problem for the health community. Leopards was a double-blind, randomized clinical trial to investigate whether levosimendan a calcium sensitizing drug reduces the severity of organ dysfunction in adults with sepsis. 516 patients in 34 Critical Care Units were randomly assigned to receive a blinded infusion of levosimendan for 24 hours or placebo in addition to standard care.
The primary outcome was the mean daily Sequential Organ Failure Assessment (SOFA) score. Secondary outcomes included 28-day mortality, time to weaning from mechanical ventilation, and adverse events. The addition of levosimendan to standard treatment in adults with sepsis was not associated with less severe organ dysfunction or lower mortality. New England Journal of Medicine, 2016; 375:1638-1648, October 27, 2016.
(behind a paywall).
OSCAR (High Frequency OSCillation in ARDS)
is a multicentre study in 29 UK Critical Care Units, 795 patients with ARDS were randomly assigned to High Frequency Oscillation or “Normal” Ventilation.
This study showed no significant benefit for either strategy. UK clinical practice has moved on significantly and patients are referred earlier for ECMO now that HFOV is not considered a suitable therapy.
A pragmatic cluster randomized controlled trial in which 4471 patients in cardiac arrest in the community either received chest compression delivered by a mechanical (Lucas2) device (1652) or manual chest compressions (2819). The device was assigned in a ratio 1:2 ambulances within each of 4 Ambulance Trusts in UK.
This very large study failed to show any benefit of this mechanical device in reducing mortality. Therefore a strong recommendation is that although these devices do no significant harm, a cost benefit of the device cannot be supported.