Effect of Targeted Temperature Management on Cerebral Autoregulation in Patients With Neurocritical Diseases

• ClinicalTrials.gov Identifier: NCT04728438
• Recruitment Status: Unknown
• First Posted: January 28, 2021
• Last Update Posted: January 28, 2021
• Sponsor: Xiangya Hospital of Central South University
• Information provided by (Responsible Party): Xiangya Hospital of Central South University

Study Description

Brief Summary:

Change and effect of cerebral autoregulation during targeted temperature management in neurocritical patients

Condition or disease
Ischemic Stroke; Subarachnoid Hemorrhage, Aneurysmal; Sepsis; TBI (Traumatic Brain Injury); ICH - Intracerebral Hemorrhage; HIE - Hypoxic - Ischemic Encephalopathy

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

• Study Type: Observational
• Estimated Enrollment: 100 participants
• Observational Model: Case-Crossover
• Time Perspective: Prospective
• Official Title: Effect of Targeted Temperature Management on Cerebral Autoregulation in Patients With Neurocritical Diseases
• Estimated Study Start Date: January 22, 2021
• Estimated Primary Completion Date: July 1, 2021
• Estimated Study Completion Date: July 1, 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. discharge mortality [ Time Frame: mortality when patients discharge，an average of 7days ]
   Mortality of patients included in the study

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

People who need to reduce the core temperature to normal

Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

• 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

Contacts and Locations

Contacts

Contact: Lina Zhang, PhD; +8615874875763; zln7095@163.com

Locations

China, Hunan

Xiangya Hospital Central South University

Changsha, Hunan, China, 410008

Contact: Xiao 86-731-84327919 xyyyllwyh@126.com

Sponsors and Collaborators

Xiangya Hospital of Central South University

Investigators

• Study Chair: Lina Zhang, PhD; Xiangya University,Central South University

More Information

• Responsible Party: Xiangya Hospital of Central South University
• ClinicalTrials.gov Identifier: NCT04728438
• Other Study ID Numbers: 202101005
• First Posted: January 28, 2021
• Last Update Posted: January 28, 2021
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiangya Hospital of Central South University:

cerebral autoregulation, targeted temperature management

Additional relevant MeSH terms:

Brain Injuries; Ischemic Stroke; Brain Injuries, Traumatic; Brain Diseases; Subarachnoid Hemorrhage; Cerebral Hemorrhage; Brain Ischemia; Ischemia; Hemorrhage; Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stroke; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages