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

Summary

The Use of sedative drugs in intensive care is widespread. A cohort study conducted in Australia and New Zealand in 2010 revealed a high prevalence of deep sedation within the first 48 hours of mechanical ventilation which was independently linked to prolonged ventilation, hospital and 180 days mortality. Clinical practice is moving towards the use of lighter levels of sedation. Recent RCTs in Europe (JAMA 2012) and previous RCTs (JAMA 2009) supports growing evidence that dexmedetomidine facilitates rousable sedation, shortens ventilation time and attenuates delirium when compared to midazolam and propofol.

The investigators confirmed in a pilot study the feasibility, efficacy and safety of a process of care known as Early Goal Directed Sedation (EGDS) that delivers:

1. Early randomization after intubation or arrival in the ICU (intubated).
2. Early Adequate analgesia after randomization.
3. Goal directed sedation titrated to achieve light sedation.
4. Dexmedetomidine based algorithm as the primary sedative agent with avoidance of benzodiazepines.

The aim of this study is to assess the effectiveness of Early Goal Directed Sedation when compared to standard care sedation in critically ill patients.

The study hypothesis is that Early Goal-Directed Sedation (EGDS), compared to standard care sedation, reduces 90-day all-cause mortality in critically ill patients who require mechanical ventilation.

Conditions

• Critical Illness and Mechanical Ventilation

Interventions

OTHER

Early goal Directed Sedation

OTHER

Standard care sedation

Sponsors & Collaborators

• National Health and Medical Research Council, Australia

  collaborator OTHER

• Australian and New Zealand Intensive Care Research Centre

  lead OTHER

Principal Investigators

• Yahya Shehabi, MD, FCICM, FANZCA, EMBA · University New South Wales, Prince of Wales Hospital, ANZIC-RC

• Rinaldo Bellomo · ANZIC-RC & Austin Hospital

• Steve A. R Webb · ANZIC-RC & Royal Perth Hospital

• Michael C Reade · ANZIC-RC, Royal Brisbane & Women's Hospital, Department of Military Medicine and Surgery,

• Belinda D Howe · ANZIC-RC

• Ian M Seppelt · ANZIC-RC, Nepean Hospital

• Colin McArthur · ANZIC-RC, Auckland Hospital

• Simon Erikson · ANZIC-RC,

• Lynne Murray · ANZIC-RC

• Suhaini Kadiman · Institut Jantung Negara, Malaysia

• Jukka Takala · Inselspital, Bern, Switzerland

• Yaseen Arabi · King Abdulaziz Medical Centre, KSA

• Matthew P Wise · University Hospital of Wales, UK

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2018-08-31

Completion

2018-12-31

Countries

• Australia
• Ireland
• Italy
• Malaysia
• New Zealand
• Saudi Arabia
• Switzerland
• United Kingdom

Study Locations