Dex on Microcirculation in SS-A Double-blinded Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Dexmedetomidine on Microcirculation in Septic Shock- A Double-blinded Study

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: Dexmedetomidine for dexmedetomidine group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine group<br>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<br>* The effect of dex and placebo for sedation on microcirculation<br>* Other names: Placebo for control group;|
| Placebo Comparator: Control group<br>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<br>* The effect of dex and placebo for sedation on microcirculation<br>* Other names: Placebo for control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microcirculatory function as assessed by Microvascular flow index | sedation for 30 minutes then monitor the microcirculation | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexmedetomidine, microcirculation, septic shock