Use of Ketamine Associate With an Opioid for Sedation in ICU
KetaRea
1 other identifier
interventional
164
1 country
1
Brief Summary
The aim of the study is to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 17, 2011
CompletedFirst Posted
Study publicly available on registry
March 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedJanuary 14, 2013
January 1, 2013
10 months
November 17, 2011
January 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of opiate used between study enrollment and mechanical ventilation withdrawal.
after 24 hours
Secondary Outcomes (5)
Confusion Duration assessed by CAM-ICU
after 24 hours
mechanical ventilation duration
after 24 hours
ICU length of stay
after 24 hours
Mortality at D28
at day 28
hyperalgesia during sedation
after 24 hours
Study Arms (2)
Rémifentanil + Kétamine
OTHERto evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
Rémifentanil + Placebo
OTHERto evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
Interventions
All consecutive mechanically ventilated patients admitted in the ICU will be randomized to receive an infusion of 0.15 mg/kg/h of kétamine or placebo. Nurses and physicians will be blinded of the allocation arm. The infusion of ketamine will be stopped as soon as remifentanil will be discontinued by the physician.
to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
Eligibility Criteria
You may qualify if:
- all patients under mechanical ventilation
You may not qualify if:
- pregnant
- psychotic
- chronic use of opiates
- age \< 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Michel CONSTANTIN
University Hospital, Clermont-Ferrand
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2011
First Posted
March 22, 2012
Study Start
October 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
January 14, 2013
Record last verified: 2013-01