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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

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.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Dexmedetomidine for dexmedetomidine group Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Dexmedetomidine on Microcirculation in Septic Shock- A Double-blinded Study
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
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
Drug: Dexmedetomidine for dexmedetomidine group
The effect of dex and placebo for sedation on microcirculation
Other Name: Placebo for control 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
Drug: Dexmedetomidine for dexmedetomidine group
The effect of dex and placebo for sedation on microcirculation
Other Name: Placebo for control group




Primary Outcome Measures :
  1. Microcirculatory function as assessed by Microvascular flow index [ Time Frame: 30 minutes ]
    sedation for 30 minutes then monitor the microcirculation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612181


Contacts
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Contact: Jingyuan Xu, M.D. 862586232550 xujingyuanmail@163.com

Locations
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China, Jiangsu
Zhongda Hospital Southeast University Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Jingyuan Xu, M.D.    862586232550    xujingyuanmail@163.com   
Principal Investigator: Jingyuan Xu, M.D.         
Sponsors and Collaborators
Southeast University, China

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Responsible Party: Jingyuan,Xu, Principal investigator, Southeast University, China
ClinicalTrials.gov Identifier: NCT02612181    
Other Study ID Numbers: 2015ZDSYLL016.1
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jingyuan,Xu, Southeast University, China:
dexmedetomidine
microcirculation
septic shock
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action