Early Goal Directed Sedation on Microcirculation in Septic Shock

April 19, 2016 updated by: Jingyuan,Xu, Southeast University, China

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Zhongda Hospital Southeast University
        • Contact:
        • Principal Investigator:
          • Jingyuan Xu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early goal directed sedation group

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
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
Other Names:
  • Control drug for sedation
Placebo Comparator: Standard sedation

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
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
Other Names:
  • Control drug for sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microcirculatory function as assessed by perfused vessel density
Time Frame: one hour
Microcirculatory parameter
one hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Dose of sedatives and analgesic agents
Time Frame: 14 days
14 days
Oxygen metabolic: lactate clearance time
Time Frame: six hours
six hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Investigators

  • Principal Investigator: Yi Yang, Ph.D., Southeast university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 28, 2014

First Submitted That Met QC Criteria

November 20, 2015

First Posted (Estimate)

November 23, 2015

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015ZDSYLL016.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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