SepsisNCT02288715
Relationship of Cerebral Perfusion Pressure Variability to Sepsis-associated Encephalopathy
An observational study of Sepsis, run by Kang Yan at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients admit to the general ICU of an academic teaching hospital
Who may be able to join
- clinical symptoms of sepsis, severe sepsis and septic shock
- age over 18 years
Who cannot join
- preexisting Neurological diseases
- traumatic brain injury
- intracranial infectious disease
- severe hepatic or renal dysfunction
- ICU discharge Within 72 hours
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sepsis
- Being tested
- no interventions
- Keywords
- cerebral perfusion pressure, septic encephalopathy
- Medical subject headings
- Sepsis, Sepsis-Associated Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionsOther
| Study group | Role | What they receive |
|---|---|---|
| SAE | patient who develop encephalopathy in the progress of sepsis Receives: Other: no interventions | |
| non-SAE | patient who do not develop encephalopathy in the progress of sepsis Receives: Other: no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: cerebral perfusion pressure is assessed up to 72 hours
Secondary outcomes (8)
Duration of mechanical ventilation
Measured: All the participants will be followed up until discharge or death, assessed up to 24 months
Time of ICU stay
Measured: All the participants will be followed up until discharge or death, assessed up to 24 months
Time of hospital stay
Measured: All the participants will be followed up until discharge or death, assessed up to 24 months
90-day mortality rate
Measured: All the participants will be followed up until 90 days after their enrollment or death
1-year mortality rate
Measured: All the participants will be followed up until 1 year after their enrollment or death
2-year mortality rate
Measured: 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
Measured: 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
Measured: All the participants will be followed up until 2 year after their enrollment or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kang Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kang Yan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288715
- Sponsor's protocol ID
- CPPV-KYan1205
- Status last verified
- Oct 2017
- First submitted
- 27 Oct 2014
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Cerebral Perfusion Pressure Variability to Sepsis-associated Encephalopathy
- ClinicalTrials.gov ID
- NCT02288715
- Acronym / sponsor ID
- CPPV-KYan1205
- Conditions
- Sepsis
- Keywords
- cerebral perfusion pressure, septic encephalopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Kang YanUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAE | – | Other: no interventionspatient who develop encephalopathy in the progress of sepsis |
| non-SAE | – | Other: no interventionspatient who do not develop encephalopathy in the progress of sepsis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients admit to the general ICU of an academic teaching hospital
Key inclusion criteria (2 listed)
- clinical symptoms of sepsis, severe sepsis and septic shock
- age over 18 years
Key exclusion criteria (6 listed)
- preexisting Neurological diseases
- traumatic brain injury
- intracranial infectious disease
- severe hepatic or renal dysfunction
- ICU discharge Within 72 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventions | Other | SAE, non-SAE |
Primary outcome
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).
8 secondary outcomes
Duration of mechanical ventilation
Time frame: All the participants will be followed up until discharge or death, assessed up to 24 months
Time of ICU stay
Time frame: All the participants will be followed up until discharge or death, assessed up to 24 months
Time of hospital stay
Time frame: All the participants will be followed up until discharge or death, assessed up to 24 months
90-day mortality rate
Time frame: All the participants will be followed up until 90 days after their enrollment or death
1-year mortality rate
Time frame: All the participants will be followed up until 1 year after their enrollment or death
2-year mortality rate
Time frame: All the participants will be followed up until 2 years after their enrollment or death
1-year quality of life of survivors
Time frame: All the participants will be followed up until 1 year after their enrollment or death
2-year quality of life of survivors
Time frame: All the participants will be followed up until 2 year after their enrollment or death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Kang Yan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relationship between cerebral perfusion pressure variability and sepsis-associated encephalopathy (time frame: cerebral perfusion pressure is assessed up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.