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

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

Study Overview

• Status: Unknown
• Conditions: Sepsis; Ischemic Stroke; TBI (Traumatic Brain Injury); Subarachnoid Hemorrhage, Aneurysmal; 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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

People who need to reduce the core temperature to normal

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
discharge mortality	Mortality of patients included in the study	mortality when patients discharge，an average of 7days

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University
• Investigators: Study Chair: Lina Zhang, PhD, Xiangya University,Central South University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 22, 2021
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): July 1, 2021

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (ACTUAL): January 28, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: cerebral autoregulation, targeted temperature management
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Stroke; Intracranial Hemorrhages; Ischemic Stroke; Brain Ischemia; Ischemia; Brain Injuries; Hemorrhage; Brain Injuries, Traumatic; Brain Diseases; Subarachnoid Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: 202101005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No