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Early Goal Directed Sedation on Microcirculation in Septic Shock

Primary Purpose

Septic Shock

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Dexmedetomidine for sedation

About this trial

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

Eligibility Criteria

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

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.

Sites / Locations

Zhongda Hospital Southeast UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Early goal directed sedation group

Standard sedation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Microcirculatory function as assessed by perfused vessel density

Microcirculatory parameter

Secondary Outcome Measures

Dose of sedatives and analgesic agents

Oxygen metabolic: lactate clearance time

Full Information

NCT ID

NCT02612363

First Posted

October 28, 2014

Last Updated

April 19, 2016

Sponsor

Southeast University, China

1. Study Identification

Unique Protocol Identification Number

NCT02612363

Brief Title

Early Goal Directed Sedation on Microcirculation in Septic Shock

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2015 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (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 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.

6. Conditions and Keywords

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

Septic Shock

Keywords

septic shock, sedation, microcirculation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Early goal directed sedation group

Arm Type

Experimental

Arm Description

Arm Title

Standard sedation

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine for sedation

Other Intervention Name(s)

Control drug for sedation

Intervention Description

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

Primary Outcome Measure Information:

Title

Microcirculatory function as assessed by perfused vessel density

Description

Microcirculatory parameter

Time Frame

one hour

Secondary Outcome Measure Information:

Title

Dose of sedatives and analgesic agents

Time Frame

14 days

Title

Oxygen metabolic: lactate clearance time

Time Frame

six hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

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

Jingyuan Xu, M.D.

Phone

0086-025-83262550

xujingyuanmail@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi Yang, Ph.D.

Organizational Affiliation

Southeast University

Official's Role

Principal Investigator

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

Learn more about this trial

Early Goal Directed Sedation on Microcirculation in Septic Shock

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