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

Southeast University, China

Status: Unknown

Conditions: Septic Shock

Treatments: Other: Local cerebral oxygen saturation

Study type: Interventional

Funder types: Other

Identifiers

NCT02706379

2015ZDSYLL036.0

Details and patient eligibility

About

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.

Full 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

Enrollment: 26 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

26 participants in 1 patient group

Local cerebral oxygen saturation

Experimental group

Description:

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

Treatment:

Other: Local cerebral oxygen saturation