- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02706379
Impact of Early Goal-Directed Therapy to Perfusion and Metabolism of Brain
March 7, 2016 updated by: Jingyuan,Xu, Southeast University, China
The Impact of Early Goal-Directed Therapy to Perfusion and Metabolism of Brain in Septic Shock Patients
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
26
Phase
- Not Applicable
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
19 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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%
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Local cerebral oxygen saturation
use NIRS technical to detect local cerebral oxygen saturation of both sides of brain
|
take blood culture before antibiotic use;measure the blood lactate;liquid rescisutation as 20ml/kg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of local cerebral oxygen saturation between early goal directed treatment(EGDT)
Time Frame: through study completion, up to 6 hours
|
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.
|
through study completion, up to 6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of neuron specific enolase(NSE)
Time Frame: through study completion, up to 6 hours
|
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.
|
through study completion, up to 6 hours
|
change of S-100 protein
Time Frame: through study completion, up to 6 hours
|
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.
|
through study completion, up to 6 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Haibo Qiu, Doctor, 13951965301
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
June 1, 2015
Primary Completion (Anticipated)
April 1, 2016
Study Completion (Anticipated)
April 1, 2016
Study Registration Dates
First Submitted
December 11, 2015
First Submitted That Met QC Criteria
March 7, 2016
First Posted (Estimate)
March 11, 2016
Study Record Updates
Last Update Posted (Estimate)
March 11, 2016
Last Update Submitted That Met QC Criteria
March 7, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015ZDSYLL036.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
The data is personal, and will not share to others.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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