Dex on Microcirculation in SS-A Double-blinded Study

Phase 4

• Conditions: Septic Shock
• Interventions: Drug: Dexmedetomidine for dexmedetomidine group

• Registration Number: NCT02612181
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-23
• Study Start: 2016-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-14
• Last Update Posted: 2017-06-15
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group	Dexmedetomidine for 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
Control group	Dexmedetomidine for dexmedetomidine 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

Primary Outcome Measures

Name	Time	Method
Microcirculatory function as assessed by Microvascular flow index	30 minutes	sedation for 30 minutes then monitor the microcirculation

Trial Locations

Locations (1)

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