Early Goal Directed Sedation on Microcirculation in Septic Shock

Phase 4

• Conditions: Septic Shock
• Interventions: Drug: Dexmedetomidine for sedation

• Registration Number: NCT02612363
• Lead Sponsor: Southeast University, China

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-10-28
• Study Start: 2015-11
• Study First Submitted QC: 2015-11-20
• Study First Posted: 2015-11-23
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-20
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early goal directed sedation group	Dexmedetomidine for sedation	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
Standard sedation	Dexmedetomidine for sedation	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

Primary Outcome Measures

Name	Time	Method
Microcirculatory function as assessed by perfused vessel density	one hour	Microcirculatory parameter

Secondary Outcome Measures

Name	Time	Method
Dose of sedatives and analgesic agents	14 days
Oxygen metabolic: lactate clearance time	six hours

Trial Locations

Locations (1)

Zhongda Hospital Southeast University; 🇨🇳 Nanjing, Jiangsu, China