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Dex on Microcirculation in SS-A Double-blinded Study

Primary Purpose

Septic Shock

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Dexmedetomidine for dexmedetomidine group

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring dexmedetomidine, microcirculation, septic shock

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Zhongda Hospital Southeast UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine group

Control group

Arm Description

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: 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

Outcomes

Primary Outcome Measures

Microcirculatory function as assessed by Microvascular flow index

sedation for 30 minutes then monitor the microcirculation

Secondary Outcome Measures

Full Information

NCT ID

NCT02612181

First Posted

November 17, 2015

Last Updated

June 14, 2017

Sponsor

Southeast University, China

1. Study Identification

Unique Protocol Identification Number

NCT02612181

Brief Title

Dex on Microcirculation in SS-A Double-blinded Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (Actual)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Southeast University, China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock

Keywords

dexmedetomidine, microcirculation, septic shock

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dexmedetomidine group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine for dexmedetomidine group

Other Intervention Name(s)

Placebo for control group

Intervention Description

The effect of dex and placebo for sedation on microcirculation

Primary Outcome Measure Information:

Title

Microcirculatory function as assessed by Microvascular flow index

Description

sedation for 30 minutes then monitor the microcirculation

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jingyuan Xu, M.D.

Phone

862586232550

xujingyuanmail@163.com

Facility Information:

Facility Name

Zhongda Hospital Southeast University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jingyuan Xu, M.D.

Phone

862586232550

xujingyuanmail@163.com

First Name & Middle Initial & Last Name & Degree

Jingyuan Xu, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Dex on Microcirculation in SS-A Double-blinded Study

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