Relationship of Cerebral Perfusion Pressure Variability to Sepsis-associated Encephalopathy

Completed

• Conditions: Sepsis
• Interventions: Other: no interventions

• Registration Number: NCT02288715
• Lead Sponsor: Kang Yan

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-11
• Primary Completion: 2015-03
• Study Completion: 2017-03
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SAE	no interventions	patient who develop encephalopathy in the progress of sepsis
non-SAE	no interventions	patient who do not develop encephalopathy in the progress of sepsis

Primary Outcome Measures

Name	Time	Method
relationship between cerebral perfusion pressure variability and sepsis-associated encephalopathy	cerebral perfusion pressure is assessed up to 72 hours	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).

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	All the participants will be followed up until discharge or death, assessed up to 24 months
Time of hospital stay	All the participants will be followed up until discharge or death, assessed up to 24 months
90-day mortality rate	All the participants will be followed up until 90 days after their enrollment or death
Time of ICU stay	All the participants will be followed up until discharge or death, assessed up to 24 months
2-year quality of life of survivors	All the participants will be followed up until 2 year after their enrollment or death	EQ-5D will be used to evaluate quality of life of survivors
1-year mortality rate	All the participants will be followed up until 1 year after their enrollment or death
2-year mortality rate	All the participants will be followed up until 2 years after their enrollment or death
1-year quality of life of survivors	All the participants will be followed up until 1 year after their enrollment or death	EQ-5D will be used to evaluate quality of life of survivors

Trial Locations

Locations (1)

Kang Yan; 🇨🇳 Chengdu, Sichuan, China