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Dex on Microcirculation in SS—A Double-blinded Study

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ClinicalTrials.gov Identifier: NCT02612181
Recruitment Status : Unknown
Verified June 2017 by Jingyuan,Xu, Southeast University, China.
Recruitment status was:  Recruiting
First Posted : November 23, 2015
Last Update Posted : June 15, 2017
Sponsor:
Information provided by (Responsible Party):
Jingyuan,Xu, Southeast University, China

Tracking Information
First Submitted Date  ICMJE November 17, 2015
First Posted Date  ICMJE November 23, 2015
Last Update Posted Date June 15, 2017
Actual Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
Microcirculatory function as assessed by Microvascular flow index [ Time Frame: 30 minutes ]
sedation for 30 minutes then monitor the microcirculation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dex on Microcirculation in SS—A Double-blinded Study
Official Title  ICMJE The Effect of Dexmedetomidine on Microcirculation in Septic Shock- A Double-blinded Study
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.
Detailed Description Dexmedetomidine is a highly selective α2-adrenoreceptor agonist for sedation of adult critically ill patients which exhibits sedative and analgesic effects. Recent studies suggest that dexmedetomidine to restore adrenergic vasoconstrictor responsiveness in septic shock, and prevents alterations of pain rat model intestinal microcirculation Induced by surgical stress,even it can reduce the mortality of endotoxemic rats and patients with severe sepsis. 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Septic Shock
Intervention  ICMJE Drug: Dexmedetomidine for dexmedetomidine group
The effect of dex and placebo for sedation on microcirculation
Other Name: Placebo for control group
Study Arms  ICMJE
  • Experimental: Dexmedetomidine group
    Dexmedetomidine 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
    Intervention: Drug: Dexmedetomidine for dexmedetomidine group
  • Placebo Comparator: Control group
    Control 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
    Intervention: Drug: Dexmedetomidine for dexmedetomidine group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 14, 2017)
44
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2015)
20
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Septic shock patients despite early goal directed therapy
  • Agree to participate this study

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02612181
Other Study ID Numbers  ICMJE 2015ZDSYLL016.1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jingyuan,Xu, Southeast University, China
Study Sponsor  ICMJE Southeast University, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Southeast University, China
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP