Ischemic StrokeNCT04728438
Effect of Targeted Temperature Management on Cerebral Autoregulation in Patients With Neurocritical Diseases
An observational study of Ischemic Stroke and Subarachnoid Hemorrhage, Aneurysmal, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Change and effect of cerebral autoregulation during targeted temperature management in neurocritical patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Subarachnoid Hemorrhage, Aneurysmal, Sepsis
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2021to 1 Jul 2021
- 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: People who need to reduce the core temperature to normal
Who may be able to join
- Aneurysmal subarachnoid hemorrhage (aSAH), Traumatic brain injury (TBI), Acute ischemic stroke (AIS), Intracerebral hemorrhage (ICH), Ischemic hypoxic encephalopathy (HIE), sepsis-associated encephalopathy (SAE) who need to reduce the core temperature to normal.
Who cannot join
- Age < 18 years old;
- Pregnancy;
- The temporal window was limited and the image could not be obtained;
- Patients with bradycardia induced by common carotid artery compression and intolerant of THRT
- Patients with severe carotid artery disease;
- Uncorrected severe coagulation disorders and active bleeding;
- Patients without informed consent;
- Patients who had been treated with hypothermia before inclusion
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Xiao, 86-731-84327919, xyyyllwyh@126.com
About this study
Change and effect of cerebral autoregulation during targeted temperature management in neurocritical patients
Read the detailed description
Cerebral autoregulation (CA) is the ability of cerebral vascular system to contract or diastole with the change of perfusion pressure, and to maintain the stability of cerebral blood flow. It has been found that there are different degrees of CA damage in patients with traumatic brain injury, ischemic stroke, hemorrhagic stroke, aneurysmal subarachnoid hemorrhage, ischemic hypoxic encephalopathy and sepsis. At the same time, studies have shown that CA damage or loss is related to brain dysfunction and poor prognosis in patients with neurocritical diseases. Therefore, early assessment and intervention of CA can help identify individuals with high risk of complications and improve outcome.
Targeted temperature management (TTM) is a kind of body temperature management started when the core temperature of patients is higher than 37.5 ℃, including achieve hypothermia (TTMhypo) and maintain normal temperature (TTMnorm). TTMhypo has been widely considered as one of the neuroprotective therapies for a variety of brain diseases and injuries, including ischemic stroke, traumatic brain injury, hypoxic brain injury caused by out-of-hospital cardiac arrest and neonatal hypoxic ischemic encephalopathy. Its neuroprotective effects in reducing brain edema, reducing intracranial pressure, reducing brain metabolism and inhibiting apoptosis have been recognized. However, the existing studies mainly focus on the effect of TTMhypo on the mortality and neurological outcome of patients with severe neurological diseases in ICU. There is no large clinical study on the effect of targeted temperature management (TTM) on cerebral autoregulation in patients with severe neurological diseases. Due to the controversy of TTMhypo on mortality and neurological outcome, this study aime to reduce the patient's core temperature to normal. Patients with severe neurological disorders who still had cerebral autoregulation dysfunction, had fever, and needed to reduce the core temperature to normal. Therefore, the effect of TTMnorm on cerebral autoregulation before and during cooling was observed.The main measures were the THRR, Mx and TOx during cooling.
- Conditions
- Ischemic Stroke, Subarachnoid Hemorrhage, Aneurysmal, Sepsis, TBI (Traumatic Brain Injury), ICH - Intracerebral Hemorrhage, HIE - Hypoxic - Ischemic Encephalopathy
- Keywords
- cerebral autoregulation, targeted temperature management
- Medical subject headings
- Ischemic Stroke, Subarachnoid Hemorrhage, Sepsis, Brain Injuries, Traumatic, Cerebral Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
discharge mortality
Mortality of patients included in the study
Measured: mortality when patients discharge，an average of 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start22 Jan 2021 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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 crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lina Zhang, PhD, Study chair, Xiangya University,Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728438
- Sponsor's protocol ID
- 202101005
- Status last verified
- Dec 2020
- First submitted
- 21 Jan 2021
- Last updated
- 28 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Targeted Temperature Management on Cerebral Autoregulation in Patients With Neurocritical Diseases
- ClinicalTrials.gov ID
- NCT04728438
- Acronym / sponsor ID
- 202101005
- Conditions
- Ischemic Stroke, Subarachnoid Hemorrhage, Aneurysmal, Sepsis, TBI (Traumatic Brain Injury), ICH - Intracerebral Hemorrhage, HIE - Hypoxic - Ischemic Encephalopathy
- Keywords
- cerebral autoregulation, targeted temperature management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 22 Jan 2021 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 28 Jan 2021 (actual)
- 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.
Change and effect of cerebral autoregulation during targeted temperature management in neurocritical patients
Detailed description
Cerebral autoregulation (CA) is the ability of cerebral vascular system to contract or diastole with the change of perfusion pressure, and to maintain the stability of cerebral blood flow. It has been found that there are different degrees of CA damage in patients with traumatic brain injury, ischemic stroke, hemorrhagic stroke, aneurysmal subarachnoid hemorrhage, ischemic hypoxic encephalopathy and sepsis. At the same time, studies have shown that CA damage or loss is related to brain dysfunction and poor prognosis in patients with neurocritical diseases. Therefore, early assessment and intervention of CA can help identify individuals with high risk of complications and improve outcome.
Targeted temperature management (TTM) is a kind of body temperature management started when the core temperature of patients is higher than 37.5 ℃, including achieve hypothermia (TTMhypo) and maintain normal temperature (TTMnorm). TTMhypo has been widely considered as one of the neuroprotective therapies for a variety of brain diseases and injuries, including ischemic stroke, traumatic brain injury, hypoxic brain injury caused by out-of-hospital cardiac arrest and neonatal hypoxic ischemic encephalopathy. Its neuroprotective effects in reducing brain edema, reducing intracranial pressure, reducing brain metabolism and inhibiting apoptosis have been recognized. However, the existing studies mainly focus on the effect of TTMhypo on the mortality and neurological outcome of patients with severe neurological diseases in ICU. There is no large clinical study on the effect of targeted temperature management (TTM) on cerebral autoregulation in patients with severe neurological diseases. Due to the controversy of TTMhypo on mortality and neurological outcome, this study aime to reduce the patient's core temperature to normal. Patients with severe neurological disorders who still had cerebral autoregulation dysfunction, had fever, and needed to reduce the core temperature to normal. Therefore, the effect of TTMnorm on cerebral autoregulation before and during cooling was observed.The main measures were the THRR, Mx and TOx during cooling.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who need to reduce the core temperature to normal
Key inclusion criteria (1 listed)
- Aneurysmal subarachnoid hemorrhage (aSAH), Traumatic brain injury (TBI), Acute ischemic stroke (AIS), Intracerebral hemorrhage (ICH), Ischemic hypoxic encephalopathy (HIE), sepsis-associated encephalopathy (SAE) who need to reduce the core temperature to normal.
Key exclusion criteria (8 listed)
- Age < 18 years old;
- Pregnancy;
- The temporal window was limited and the image could not be obtained;
- Patients with bradycardia induced by common carotid artery compression and intolerant of THRT
- Patients with severe carotid artery disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
discharge mortality
Time frame: mortality when patients discharge，an average of 7days
Mortality of patients included in the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
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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.
Lina Zhang, PhD study chair
Xiangya University,Central South University
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 Ischemic Stroke and Subarachnoid Hemorrhage, Aneurysmal, run by Xiangya Hospital of Central South University 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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 28 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lina Zhang, PhD (+8615874875763, zln7095@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
discharge mortality (time frame: mortality when patients discharge，an average of 7days). 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 28 Jan 2021.