Early Goal Directed Sedation on Microcirculation in Septic Shock

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02612363
• Other study ID #: 2015ZDSYLL016.0
• Status: Recruiting
• Phase: Phase 4
• First received: October 28, 2014
• Last updated: April 19, 2016
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: April 2016
• Source: Southeast University, China
• Contact: Jingyuan Xu, M.D.
• Phone: 0086-025-83262550
• Email: xujingyuanmail[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Dexmedetomidine for sedation
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

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 perfused vessel density	Microcirculatory parameter	one hour	No
Secondary	Dose of sedatives and analgesic agents		14 days	Yes
Secondary	Oxygen metabolic: lactate clearance time		six hours	Yes