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CompletedNCT02288715Updated Nov 6, 2017

Relationship of Cerebral Perfusion Pressure Variability to Sepsis-associated Encephalopathy

An observational study in Sepsis, sponsored by Kang Yan. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-06.

Sponsored by Kang Yan · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
110
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Sepsis

Keywords

  • cerebral perfusion pressure
  • septic encephalopathy
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In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 110 is below the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Kang Yan is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
110 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Otherno interventions
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What researchers measure

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).

    Time frame: cerebral perfusion pressure is assessed up to 72 hours

Secondary outcomes

  1. Duration of mechanical ventilation

    Time frame: All the participants will be followed up until discharge or death, assessed up to 24 months

  2. Time of ICU stay

    Time frame: All the participants will be followed up until discharge or death, assessed up to 24 months

  3. Time of hospital stay

    Time frame: All the participants will be followed up until discharge or death, assessed up to 24 months

  4. 90-day mortality rate

    Time frame: All the participants will be followed up until 90 days after their enrollment or death

  5. 1-year mortality rate

    Time frame: All the participants will be followed up until 1 year after their enrollment or death

  6. 2-year mortality rate

    Time frame: All the participants will be followed up until 2 years after their enrollment or death

  7. 1-year quality of life of survivors

    EQ-5D will be used to evaluate quality of life of survivors

    Time frame: All the participants will be followed up until 1 year after their enrollment or death

  8. 2-year quality of life of survivors

    EQ-5D will be used to evaluate quality of life of survivors

    Time frame: All the participants will be followed up until 2 year after their enrollment or death

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Study locations

1 site
  • Kang Yan
    Chengdu, Sichuan 610041, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02288715
Lead sponsor
Kang Yan
Responsible party
Kang Yan (Director of Intensive Care Unit, West China Hospital) — Sponsor-investigator
First posted
Nov 11, 2014
Start date
May 2014
Primary completion
Mar 2015
Completion
Mar 2017
Last update
Nov 6, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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