Early Goal-Directed Sedation Compared With Standard Care in Mechanically Ventilated Critically Ill Patients

Launched by AUSTRALIAN AND NEW ZEALAND INTENSIVE CARE RESEARCH CENTRE · Nov 13, 2012

Keywords

ClinConnect Summary

This is a large-scale study into the effectiveness of a novel approach for sedation in ventilated critically ill patients. The primary aim of this study is to determine whether Early Goal Directed Sedation therapy, compared to standard care sedation, reduces 90-day mortality in critically ill patients ventilated \> 24 hrs.

The study will be a randomized, unblinded, controlled trial conducted in approximately 35-50 intensive care units (ICUs) and will recruit 4000 mechanically ventilated patients (life support) who are expected to remain on the ventilator \> 24 hours AND require immediate o...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient has been intubated and is receiving mechanical ventilation
• • The treating clinician expects that the patient will remain intubated until the day after tomorrow (unlikely to be extubated the following day).
• • The patient requires immediate ongoing sedative medication for comfort, safety, and to facilitate the delivery of life support measures.
• Exclusion Criteria:
• • Age less than 18 years
• • Patient is pregnant and/or lactating
• • Has been intubated (excluding time spent intubated within an operating theatre or transport) for greater than 12 hours in an intensive care unit.
• • Proven or suspected acute primary brain lesion such as traumatic brain injury, intracranial haemorrhage, stroke, or hypoxic brain injury.
• • Proven or suspected spinal cord injury or other pathology that may result in permanent or prolonged weakness.
• • Admission as a consequence of a suspected or proven drug overdose or burns.
• • Administration of ongoing neuromuscular blockade.
• • A mean arterial blood (MAP) pressure that is less than 50 mmHg despite adequate resuscitation and vasopressor therapy at time of randomisation
• • Heart rate less than 55 beats per minute unless the patient is being treated with a beta-blocker or a high grade atrio-ventricular block in the absence of a functioning pacemaker.
• • Known sensitivity to any of the study medications or the constituents of propofol (egg, soya or peanut protein)
• • Acute fulminant hepatic failure
• • Patient has been receiving full time residential nursing care.
• • Death is deemed to be imminent or inevitable during this admission and either the attending physician, patient or substitute decision maker is not committed to active treatment.
• • Patient has an underlying disease that makes survival to 90 days unlikely
• • Patient has been previously enrolled in the SPICE study.