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

NCT02706379 | Unknown

• 1 other identifier: 2015ZDSYLL036.0
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Septic Shock

Outcome Measures

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.

  through study completion, up to 6 hours

Secondary Outcomes (2)

• change of neuron specific enolase(NSE)

  through study completion, up to 6 hours

• change of S-100 protein

  through study completion, up to 6 hours

Study Arms (1)

Local cerebral oxygen saturation

EXPERIMENTAL

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

Other: Local cerebral oxygen saturation

Interventions

Local cerebral oxygen saturation OTHER

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

Local cerebral oxygen saturation

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Southeast University, China: lead

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Haibo Qiu, Doctor

  13951965301

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: March 11, 2016
• Study Start: June 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 11, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share