Early Goal Directed Sedation on Microcirculation in Septic Shock
NCT ID: NCT02612363
Last Updated: 2016-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
25 participants
INTERVENTIONAL
2015-11-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Early goal directed sedation group
Dexmedetomidine for sedation in early goal directed sedation group
* Analgesia
* Dexmedetomidine start at 0.7ug/kg/hour
* Dose range: 0.2- 0.7 u/kg/hour
* Supplemental other sedatives at lowest effective dose Target Richmond Agitation-Sedation Scale score of -2 to +1 to achieve sedation goal in EGDS group
Dexmedetomidine for sedation
Dexmedetomidine or control drug for sedation
* Analgesia
* Propofol at lowest dosage.
* Dose range: 0.1- 0.7 u/kg/hour
* Target RASS score of -2 to +1
* Supplemental other sedatives at lowest effective dose
Standard sedation
Control drug for sedation in early goal directed sedation group
* Analgesia
* Control drug
* Supplemental other sedatives at lowest effective dose for standard sedation Target Richmond Agitation-Sedation Scale score of -2 to +1 to achieve sedation goal
Dexmedetomidine for sedation
Dexmedetomidine or control drug for sedation
* Analgesia
* Propofol at lowest dosage.
* Dose range: 0.1- 0.7 u/kg/hour
* Target RASS score of -2 to +1
* Supplemental other sedatives at lowest effective dose
Interventions
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Dexmedetomidine for sedation
Dexmedetomidine or control drug for sedation
* Analgesia
* Propofol at lowest dosage.
* Dose range: 0.1- 0.7 u/kg/hour
* Target RASS score of -2 to +1
* Supplemental other sedatives at lowest effective dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Required sedation
Exclusion Criteria
* Pregnancy
* Bradycardia (HR\<55bpm)
* Systolic blood pressure \< 80 mmHg / mean arterial pressure \< 50 mmHg on maximal support
* Death imminent
* Unlikely to survive 90 days
* Acute liver failure
* Dementia
* High-grade block in the absence of a functioning pacemaker.
18 Years
ALL
No
Sponsors
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Southeast University, China
OTHER
Responsible Party
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Jingyuan,Xu
Principal investigator
Principal Investigators
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Yi Yang, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Southeast University
Locations
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Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2015ZDSYLL016.0
Identifier Type: -
Identifier Source: org_study_id
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