CClinicalTrials.gg
Status unknownNCT02706379Updated Mar 11, 2016

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

An interventional study of Local cerebral oxygen saturation in Septic Shock, sponsored by Southeast University, China. Status unknown. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-03-11.

Sponsored by Southeast University, China · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
19 Years to 85 Years
Sex
All
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Study 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.

Read the detailed description
  1. 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
  2. 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
  3. 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
  4. monitoring of hemodynamics and cerebral perfusion and metabolic indicators
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Conditions studied

  • Septic Shock

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03

In context

Shock, Septic

862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.

This study's planned enrollment of 26 is below the median of 80 across 530 interventional studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Southeast University, China is the lead sponsor of 164 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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%
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    Local cerebral oxygen saturation

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

    Other: Local cerebral oxygen saturation

Interventions

  • OtherLocal cerebral oxygen saturation

    take blood culture before antibiotic use;measure the blood lactate;liquid rescisutation as 20ml/kg

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: through study completion, up to 6 hours

Secondary outcomes

  1. 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.

    Time frame: through study completion, up to 6 hours

  2. 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.

    Time frame: through study completion, up to 6 hours

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — The data is personal, and will not share to others.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02706379
Lead sponsor
Southeast University, China
Responsible party
Jingyuan,Xu (director, Southeast University, China) — Principal investigator
First posted
Mar 11, 2016
Start date
Jun 2015
Primary completion
Apr 2016 (estimated)
Completion
Apr 2016 (estimated)
Last update
Mar 11, 2016

Study contacts

Haibo Qiu, Doctor
study director · 13951965301

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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