Dex on Microcirculation in SS—A Double-blinded Study

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02612181
• Other study ID #: 2015ZDSYLL016.1
• Status: Recruiting
• Phase: Phase 4
• First received: November 17, 2015
• Last updated: June 14, 2017
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2017
• Source: Southeast University, China
• Contact: Jingyuan Xu, M.D.
• Phone: 862586232550
• Email: xujingyuanmail[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Dexmedetomidine for dexmedetomidine group
The effect of dex and placebo for sedation on microcirculation

Locations

Country	Name	City	State
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microcirculatory function as assessed by Microvascular flow index	sedation for 30 minutes then monitor the microcirculation	30 minutes