SPICE III

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Shehabi Y. "Early Sedation with Dexmedetomidine in Critically Ill Patients". NEJM. 2019. ePub ahead of print:.
PubMedClinicalTrials.gov

Clinical Question

Bottom Line

Major Points

Guidelines

As of June 2018, no guidelines have been published that reflect the results of this trial.

Design

  • Multicenter, open-label, randomized, control trial
  • N=4000
    • Dexmedetomidine (n=1954)
    • Usual Care (n=1964)
  • Setting: 74 ICUs in 8 countries (Australia, Ireland, Italy, Malaysia, New Zealand, Saudi Arabia, Switzerland, and the UK)
  • Enrollment: November 2013 - February 2018
  • Mean follow-up:
  • Analysis: modified intention-to-treat
  • Primary Outcome: 90 day mortality

Population

Inclusion Criteria

  • receiving mechanical ventilation through an endotracheal tube,
  • expected to receive ventilatory support beyond the next full calendar day
  • receiving sedatives for safety and comfort

Exclusion Criteria

  • age < 18 years
  • invasive ventilation in the ICU for longer than 12 hours before enrollment
  • suspected or proven acute primary brain injury

Baseline Characteristics

BLANK Group displayed

  • Demographics:
  • Physiologic parameters:
  • Anthropomorphics: Weight
  • Labs:
  • Site of infection

Interventions

Outcomes

Comparisons are dexemetomidine vs. Usual care.

Primary Outcomes

90 day all-cause mortality
29.1% vs. 29.1% (OR 1.00, Difference 0, 95% CI −2.9 to 2.8) P = 0.98

Secondary Outcomes

Subgroup Analysis

Adverse Events

Criticisms

Funding

  • Funded by:
    • National Health and Medical Research Council of Australia
    • Health Research Council of New Zealand,
    • Institut Jantung Negara Foundation of Malaysia
  • Pfizer and Orion Pharma supplied dexmedetomidine

Further Reading