Dex on Microcirculation in SS-A Double-blinded Study
The Effect of Dexmedetomidine on Microcirculation in Septic Shock- A Double-blinded Study
1 other identifier
interventional
44
1 country
1
Brief Summary
The investigators preliminary study showed that dexmedetomidine might improve microcirculation in septic shock patients. To test this effect, the investigators will conduct double-blinded study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2015
CompletedFirst Posted
Study publicly available on registry
November 23, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJune 15, 2017
June 1, 2017
1.9 years
November 17, 2015
June 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Microcirculatory function as assessed by Microvascular flow index
sedation for 30 minutes then monitor the microcirculation
30 minutes
Study Arms (2)
Dexmedetomidine group
EXPERIMENTALDexmedetomidine group: Dexmedetomidine infusion for dexmedetomidine group to the goal of sedation: Richmond agitation-sedation scale 0 to -2 Dexmedetomidine doses 0-0.7 mcg/kg/h
Control group
PLACEBO COMPARATORControl group: Placebo infusion for control group to the goal of sedation: Richmond agitation-sedation scale 0 to -2 Control drug doses 0-0.7 mcg/kg/h
Interventions
The effect of dex and placebo for sedation on microcirculation
Eligibility Criteria
You may qualify if:
- Septic shock patients despite early goal directed therapy
- Agree to participate this study
You may not qualify if:
- Age\< 18
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
November 17, 2015
First Posted
November 23, 2015
Study Start
January 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
June 15, 2017
Record last verified: 2017-06