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Impact of Early Goal-Directed Therapy to Perfusion and Metabolism of Brain

Primary Purpose

Septic Shock

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Local cerebral oxygen saturation
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • New infectious shock in accordance with the diagnostic criteria of the 2012 SSC guidelines;
  • Liquid recovery is not fully achieved EGDT standards, at least meet the following criteria:

    • mean arterial pressure < 65mmHg
    • central venous pressure < 8mmHg
    • per hour urine volume was less than 0.5ml/kg
    • central venous oxygen saturation <70%
    • arterial blood lactic acid value > 2.5mmol/L
  • Signed informed consent

Exclusion Criteria:

  • Subjects/subjects client reject the invasive hemodynamic monitoring
  • have contraindications to place hemodynamic monitoring
  • unconsciousness state before septic shock and GCS<12
  • cannot put the electrodes on the eyebrow
  • pregnant or lactating women
  • end stage of illness or death rate is more than 80%

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Local cerebral oxygen saturation

    Arm Description

    use NIRS technical to detect local cerebral oxygen saturation of both sides of brain

    Outcomes

    Primary Outcome Measures

    change of local cerebral oxygen saturation between early goal directed treatment(EGDT)
    Test the local cerebral oxygen saturation of both sides of brain through near infrared spectroscopy technology. And record the change of local cerebral oxygen of the left and right's brain.

    Secondary Outcome Measures

    change of neuron specific enolase(NSE)
    NSE is an enzyme that in humans is encoded by the ENO2 gene. NSE is produced by small cell carcinomas which are neuroendocrine in origin, and the raise of its concentration indicates the injury of brain.
    change of S-100 protein
    S-100 protein S100 proteins are normally present in cells derived from the neural crest (Schwann cells, and melanocytes), chondrocytes, adipocytes, myoepithelial cells, macrophages, Langerhans cells, dendritic cells, and keratinocytes.S100 proteins have been implicated in a variety of intracellular and extracellular functions.

    Full Information

    First Posted
    December 11, 2015
    Last Updated
    March 7, 2016
    Sponsor
    Southeast University, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02706379
    Brief Title
    Impact of Early Goal-Directed Therapy to Perfusion and Metabolism of Brain
    Official Title
    The Impact of Early Goal-Directed Therapy to Perfusion and Metabolism of Brain in Septic Shock Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    April 2016 (Anticipated)
    Study Completion Date
    April 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Southeast University, China

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Early goal directed therapy (EGDT) is an effective treatment for patients with septic shock, which is widely used in clinic. Fluid resuscitation can significantly reduce the mortality of patients with septic shock and improve the prognosis of patients with EGDT. However, in recent years, the standard of EGDT to determine the existence of the target of septic shock. Some studies have shown that there may be a manifestation of the deficiency of kidney and liver and other organs such as kidney, liver and other organs in the recovery of EGDT. Therefore, this experiment is to explore the brain perfusion and metabolism of the EGDT when the target is reached.The aim of this study was to investigate the effects of EGDT as a guide to the cerebral perfusion and metabolism in order to provide clinical evidence for the treatment of fluid resuscitation in patients with septic shock.
    Detailed Description
    patients enrollment this project: Met the inclusion criteria without exclusion criteria were entered test, and record the general information, including name, hospital number, gender, age, height, weight, admission, and in time, ICU admission and in ICU diagnosis, previous underlying diseases, into the group of APACHE II score and SOFA score implement septic shock bundle: measurement the value of lactic acid of patients after administrating of ICU, take blood culture before antibiotic using, give wide-spectrum antibiotic treatment and began liquid resuscitation preparation: A. basic state records B. using CAM-ICU delirium assessment for patients, and record the assessment results C. cerebral oxygen saturation monitor D. via the jugular vein placed central venous catheter and femoral artery placed PiCCO catheter monitoring of hemodynamics and cerebral perfusion and metabolic indicators

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    26 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Local cerebral oxygen saturation
    Arm Type
    Experimental
    Arm Description
    use NIRS technical to detect local cerebral oxygen saturation of both sides of brain
    Intervention Type
    Other
    Intervention Name(s)
    Local cerebral oxygen saturation
    Intervention Description
    take blood culture before antibiotic use;measure the blood lactate;liquid rescisutation as 20ml/kg
    Primary Outcome Measure Information:
    Title
    change of local cerebral oxygen saturation between early goal directed treatment(EGDT)
    Description
    Test the local cerebral oxygen saturation of both sides of brain through near infrared spectroscopy technology. And record the change of local cerebral oxygen of the left and right's brain.
    Time Frame
    through study completion, up to 6 hours
    Secondary Outcome Measure Information:
    Title
    change of neuron specific enolase(NSE)
    Description
    NSE is an enzyme that in humans is encoded by the ENO2 gene. NSE is produced by small cell carcinomas which are neuroendocrine in origin, and the raise of its concentration indicates the injury of brain.
    Time Frame
    through study completion, up to 6 hours
    Title
    change of S-100 protein
    Description
    S-100 protein S100 proteins are normally present in cells derived from the neural crest (Schwann cells, and melanocytes), chondrocytes, adipocytes, myoepithelial cells, macrophages, Langerhans cells, dendritic cells, and keratinocytes.S100 proteins have been implicated in a variety of intracellular and extracellular functions.
    Time Frame
    through study completion, up to 6 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: New infectious shock in accordance with the diagnostic criteria of the 2012 SSC guidelines; Liquid recovery is not fully achieved EGDT standards, at least meet the following criteria: mean arterial pressure < 65mmHg central venous pressure < 8mmHg per hour urine volume was less than 0.5ml/kg central venous oxygen saturation <70% arterial blood lactic acid value > 2.5mmol/L Signed informed consent Exclusion Criteria: Subjects/subjects client reject the invasive hemodynamic monitoring have contraindications to place hemodynamic monitoring unconsciousness state before septic shock and GCS<12 cannot put the electrodes on the eyebrow pregnant or lactating women end stage of illness or death rate is more than 80%
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Haibo Qiu, Doctor
    Organizational Affiliation
    13951965301
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The data is personal, and will not share to others.

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    Impact of Early Goal-Directed Therapy to Perfusion and Metabolism of Brain

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