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Clinical Trials/EUCTR2013-003307-20-IT
EUCTR2013-003307-20-IT
Active, Not Recruiting
N/A

Sedation Practices in Intensive Care Evaluation: SPICE III – A Prospective Multicentre Randomised Controlled Trial of Early Goal Direct Sedation vs. Standard Care Sedation”

ANZIC RESEARCH CENTRE0 sites4,000 target enrollmentOctober 22, 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
ANZIC RESEARCH CENTRE
Enrollment
4000
Status
Active, Not Recruiting
Last Updated
11 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 22, 2013
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ANZIC RESEARCH CENTRE

Eligibility Criteria

Inclusion Criteria

  • \-age over 18 years;
  • \-patient intubated and subjected to mechanical ventilation;
  • \-patient to high likelihood of mechanical ventilation for more than 24 hours (unlikely extubating the following day);
  • \-patient requiring immediate sedation for the management of his/her comfort, security, and to facilitate the intensive treatment
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 100
  • F.1\.3 Elderly (\>\=65 years) yes
  • F.1\.3\.1 Number of subjects for this age range 100

Exclusion Criteria

  • \-Patient under the age of 18 years;
  • \-Patient intubated for more than 12 hours in an ICU (excluding any operating room time or transport);
  • \-acute injury certain or suspected primary acute brain barrier, such as head trauma, intracranial hemorrhage, brain injury, stroke or hypoxia;
  • \-death is considered imminent or inevitable during hospitalization;

Outcomes

Primary Outcomes

Not specified

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