Ignite Creation Date:
2024-05-06 @ 12:54 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03879317
Status:
UNKNOWN
Last Update Posted:
2019-06-12
First Post:
2019-03-06
Brief Title:
NIRS Directed Optimal Cerebral Perfusion Pressure in Septic Shock Patients A Feasibility Study
Sponsor:
Xiangya Hospital of Central South University
Organization:
Xiangya Hospital of Central South University
Study Overview
Official Title:
NIRS Directed Optimal Cerebral Perfusion Pressure in Septic Shock Patients A Feasibility Study
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
After the initial injury secondary insults including poor cerebral perfusion are main contributors to poor outcome and their early detection and amelioration are keystone to neurocritical care Nonetheless the guidelines for blood pressure management still recommend a single target blood pressure for critically ill patients the international Guidelines for management of sepsis recommend a MAP of at least 65 mmHg Some guidelines recognize that patients with a history of hypertension may require a higher MAP However these guidelines do not currently recommend cerebral autoregulation-guided therapy and leave many unanswered questions Cerebral autoregulation is the mechanism that maintains cerebral blood supply hence CBF approximately constant despite changes in MAP or more precisely despite changes in CPP Maintaining blood pressure within the cerebral blood flow CBF autoregulation range termed optimal MAP is associated with improved outcomes for patients The observational data suggests that management of patients above or below CPPopt 5mmHg is associated with better outcomes and mortality than the other greater variation rangeThe most commonly used method for monitoring dynamic cerebrovascular reactivity is the pressure reactivity index PRx that uses ICP as a surrogate for CBV However assessing the PRx requires invasive ICP monitoring which limits its application in many clinical areas Alternatively in the absence of invasive intracranial pressure monitoring to determine CPP a continuous autoregulation monitoring can be accomplished by the continuous correlation between transcranial Doppler TCD-measured CBF velocity of the middle cerebral artery and the mean arterial blood pressure termed mean velocity index or Mx Mx is a validated index of cerebral autoregulation based on measures of cerebral perfusion pressure and mean flow velocity on transcranial doppler but is impractical for longer-term monitoring and requires system training the results are operator-dependent Near-infrared spectroscopy NIRS measurements is another alternative for real-time autoregulation monitoring in the form of a Tissue Oxygenation Index In contrast to TCD the NIRS sensors are very easy to apply the probes attach to the forehead with self-adhesive pads and do not require frequent calibration making them more suitable for long-term monitoring Therefore in this study Patients in the intervention group will be monitored by continuous NIRS and invasive blood pressure monitoring The correlation curve between ORITHx and blood pressure will be obtained through continuous monitoring According to the correlation curve the optimal blood pressure which provides the optimal CPP will be determined
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None