Not Yet RecruitingPhase 2Phase 3ACTRN12611000166976

Sedation Practice in Intensive Care in Australia and New Zealand- A Pilot Study

A randomised controlled trial of a sedative regimen that utilises dexmedetomidine as the primary agent and minimises the use of midazolam compared with current sedation practice in intensive care patients on outcomes of mortality, cognitive function and Health Related Quality of Life.

Sponsor

ANZIC-research centre, Monash University

Enrollment

60 participants

Start Date

Apr 11, 2011

Study Type

Interventional

Conditions

Sedation in intensive care patients

Summary

The purpose of the SPICE Pilot RCT is to obtain preliminary data on the feasibility of conducting a large phase III RCT. The hypothesis of the proposed RCT is that a sedation regimen based on dexmedetomidine as the primary sedative agent, and in which benzodiazepine use is minimised, will lead to improved patient centred outcomes.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria6

Patients eligible for the study must meet these 2 criteria:
The patient is mechanically ventilated via an endotracheal tube and has been intubated, (excluding time spent intubated within an operating or procedural theatre), for less than 12 hours, and the treating clinician believes that:
The patient requires immediate AND ongoing sedative medication for comfort, safety, and to facilitate the delivery of life support measures.
The choice of the sedative medications needs to be determined now
There is uncertainty whether a sedative regimen using dexmedetomidine as the primary agent or the clinicians usual choice of sedative regimen for this patient is superior, AND
The patient is expected to remain intubated the day after tomorrow.

Exclusion Criteria18

Patients will be excluded from the study if any of the following criteria apply:
Age less than 18 years,
Patient is pregnant and/or lactating.
Patient has a proven or suspected acute primary brain lesion that may result in global impairment of conscious level or cognition, such as traumatic brain injury, intracranial haemorrhage, stroke, or hypoxic brain injury.
Patient has a proven or suspected cervical spinal cord injury or pathology that may result in permanent or prolonged weakness of upper and lower limbs.
Patient has proven or suspected primary neurological pathology associated with prolonged weakness, such as Guillain-Barre syndrome
Patient has been admitted as a consequence of a drug overdose
Patient has burn injuries
Patient is receiving or expected to need ongoing neuromuscular blockade
Patient has allergy to propofol or dexmedetomidine
Patient’s mean arterial blood (MAP) pressure is less than 55 mmHg despite resuscitation and vasopressor therapy
Patient has a heart rate (HR) less than 55/min unless being treated with a beta blocker
Patient has a high grade atrio-ventricular block in the absence of a functioning pacemaker
Patient has end stage liver failure or acute fulminant hepatic failure
Patient does not speak English
Death is deemed imminent and inevitable
Patient is a nursing home resident
Patient has an underlying disease that makes survival to 90 days unlikely.

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Interventions

Arm 1 Known as Grp DexP-sedation regime with dexmedetomidine as the primary agent. Dexmedetomidine up to 1 to 1.5 mcg/kg/hour to achieve desired sedation level. Given via infusion as required for up

Arm 1 Known as Grp DexP-sedation regime with dexmedetomidine as the primary agent. Dexmedetomidine up to 1 to 1.5 mcg/kg/hour to achieve desired sedation level. Given via infusion as required for up to a max of 30 days. Arm 2 Grp Std care- standard care sedation as per site's normal practice. Given via infusion as required.

Locations(1)

Auckland, New Zealand

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ACTRN12611000166976