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

Septic Shock Clinical Trial

Official title:

The Impact of Early Goal-Directed Therapy to Perfusion and Metabolism of Brain in Septic Shock Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02706379
• Other study ID #: 2015ZDSYLL036.0
• Status: Active, not recruiting
• Phase: N/A
• First received: December 11, 2015
• Last updated: March 7, 2016
• Start date: June 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2016
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 85 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock, Septic

Intervention

Other:
• Local cerebral oxygen saturation
take blood culture before antibiotic use;measure the blood lactate;liquid rescisutation as 20ml/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	through study completion, up to 6 hours	Yes
Secondary	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.	through study completion, up to 6 hours	Yes