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Completed

NCT Number: NCT02288715

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.

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Key information

Conditions

Sepsis Brain Diseases Central Nervous System Diseases Infections Inflammation Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis-Associated Encephalopathy Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kang Yan

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No interventions

Other

Primary outcomes

  1. relationship between cerebral perfusion pressure variability and sepsis-associated encephalopathy

    Time frame: 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 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

    Time frame: 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

  8. 2-year quality of life of survivors

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kang Yan

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Nov 11, 2014
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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