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
About this trial
This is an interventional treatment trial for Septic Shock
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%
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
NCT ID
NCT02706379
First Posted
December 11, 2015
Last Updated
March 7, 2016
Sponsor
Southeast University, China
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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