Relationship of Cerebral Perfusion Pressure Variability to Sepsis-associated Encephalopathy

NCT02288715 | Completed

• 1 other identifier: CPPV-KYan1205
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

cerebral perfusion pressure; septic encephalopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

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

Interventions

no interventions OTHER

SAE; non-SAE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• clinical symptoms of sepsis, severe sepsis and septic shock
• age over 18 years

You may not qualify if:

• preexisting Neurological diseases
• traumatic brain injury
• intracranial infectious disease
• severe hepatic or renal dysfunction
• ICU discharge Within 72 hours
• pregnancy

Sponsors & Collaborators

• Kang Yan: lead

Study Sites (1)

Kang Yan

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Sepsis; Sepsis-Associated Encephalopathy

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Intensive Care Unit

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: November 11, 2014
• Study Start: May 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-10

Locations

CN (1)