Relationship of Cerebral Perfusion Pressure Variability to Sepsis-associated Encephalopathy

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Other: no interventions

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 Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Kang Yan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

all patients admit to the general ICU of an academic teaching hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SAE; patient who develop encephalopathy in the progress of sepsis	Other: no interventions
non-SAE; patient who do not develop encephalopathy in the progress of sepsis	Other: no interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of mechanical ventilation		All the participants will be followed up until discharge or death, assessed up to 24 months
Time of ICU stay		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
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	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
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

Collaborators and Investigators

• Sponsor: Kang Yan

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: October 27, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (Estimate): November 11, 2014

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: cerebral perfusion pressure; septic encephalopathy
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Brain Diseases; Sepsis-Associated Encephalopathy
• Other Study ID Numbers: CPPV-KYan1205