Evaluation of sedation in intensive therapy

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003307-20-IT

Enrollment

4000

Registered

2013-10-22

Start date

2014-11-06

Completion date

Unknown

Last updated

2014-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adult patients hospitalized in intensive therapy unit undergoing continuous and immediate sedation for at least 24 hours

Interventions

Trade Name: DEXDOR Product Name: DEXMEDETOMIDINE Pharmaceutical Form: Solution for infusion INN or Proposed INN: DEXMEDETOMIDINE CAS Number: 113775-47-6 Current Sponsor code: DEXMEDETOMIDINE Other des

Eligibility

Sex/Gender

All

Inclusion 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

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;

Design outcomes

Primary

Measure	Time frame
Main Objective: improvement in mortality of patients hospitalized in intensive therapy unit mechanically ventilated;Secondary Objective: morbility improvement;Primary end point(s): Improving mortality of ICU patients mechanically ventilated within 90 days and 180 ;Timepoint(s) of evaluation of this end point: 90-180 days	—

Secondary

Measure	Time frame
Secondary end point(s): Improvement in morbidity;Timepoint(s) of evaluation of this end point: 90-180 days	—

Countries

Australia, Italy

Contacts

Public Contactanaesthesia and rianimation

Ospedale San Raffaele

leggieri.carlo@hsr.it00390226432222

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026