Early Goal Directed Sedation on Microcirculation in Septic Shock

Study Overview
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Brief Summary
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The investigators will conduct a prospective, single-center, randomized, double-blinded, controlled study to investigate the effect of early goal directed sedation on microcirculation in early septic shock patients.

Detailed Description
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Recent studies suggest that early goal directed sedation might improve the outcome of critically ill patients. The investigators will conduct a prospective, single-center, randomized, double-blinded, controlled study to investigate the effect of early goal directed sedation on microcirculation in early septic shock patients with relative stable hemodynamics.

Official Title
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The Effect of Early Goal Directed Sedation on Microcirculation in Septic Shock Patients With Mechanical Ventilation

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: Dexmedetomidine for sedation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Septic shock patients despite early goal directed therapy Required sedation 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

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: Early goal directed sedation group<br>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 | Drug: Dexmedetomidine for sedation<br>* 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<br>* Other names: Control drug for sedation;|
| Placebo Comparator: Standard sedation<br>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 | Drug: Dexmedetomidine for sedation<br>* 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<br>* Other names: Control drug for sedation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microcirculatory function as assessed by perfused vessel density | Microcirculatory parameter | one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of sedatives and analgesic agents |  | 14 days | 
| Oxygen metabolic: lactate clearance time |  | six hours | 

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