Relationship of Cerebral Perfusion Pressure Variability to Sepsis-associated Encephalopathy

Sepsis Clinical Trial

Official title:

Relationship of Cerebral Perfusion Pressure Variability to Sepsis-associated Encephalopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288715
• Other study ID #: CPPV-KYan1205
• Status: Completed
• Phase: N/A
• First received: October 27, 2014
• Last updated: October 31, 2017
• Start date: May 2014
• Est. completion date: March 2017

Study information

• Verified date: October 2017
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to evaluate whether variability of CPP (cerebral perfusion pressure) is related to sepsis-associated encephalopathy and outcomes of patients with sepsis.

Description:

Encephalopathy is a common complication of sepsis, impaired cerebrovascular autoregulation (AR) in patients with sepsis is considered related to Sepsis-associated encephalopathy (SAE). As AR is important in stabilizing the cerebral perfusion pressure, whether greater variability of CPP is related to SAE and mortality or not remains unclear. We conduct this study to evaluate the relationship between them.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2017
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• clinical symptoms of sepsis, severe sepsis and septic shock

• age over 18 years

Exclusion Criteria:

• preexisting Neurological diseases

• traumatic brain injury

• intracranial infectious disease

• severe hepatic or renal dysfunction

• ICU discharge Within 72 hours

• pregnancy

Related Conditions & MeSH terms

• Brain Diseases
• Sepsis
• Sepsis-Associated Encephalopathy
• Toxemia

Intervention

Other:
• no interventions

Locations

Country	Name	City	State
China	Kang Yan	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Kang Yan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relationship between cerebral perfusion pressure variability and sepsis-associated encephalopathy	To estimate CPP noninvasively, we will monitor the middle cerebral artery flow velocity of patients with sepsis using transcranial Doppler ultrasound in the first 72h of their enrollment. Diagnosis of a SAE was performed using the confusion assessment method for ICU(CAM-ICU).	cerebral perfusion pressure is assessed up to 72 hours
Secondary	Duration of mechanical ventilation		All the participants will be followed up until discharge or death, assessed up to 24 months
Secondary	Time of ICU stay		All the participants will be followed up until discharge or death, assessed up to 24 months
Secondary	Time of hospital stay		All the participants will be followed up until discharge or death, assessed up to 24 months
Secondary	90-day mortality rate		All the participants will be followed up until 90 days after their enrollment or death
Secondary	1-year mortality rate		All the participants will be followed up until 1 year after their enrollment or death
Secondary	2-year mortality rate		All the participants will be followed up until 2 years after their enrollment or death
Secondary	1-year quality of life of survivors	EQ-5D will be used to evaluate quality of life of survivors	All the participants will be followed up until 1 year after their enrollment or death
Secondary	2-year quality of life of survivors	EQ-5D will be used to evaluate quality of life of survivors	All the participants will be followed up until 2 year after their enrollment or death