Clinical trial NCT03879317: NIRS Directed Optimal Cerebral Perfusion Pressure in Septic Shock Patients: A Feasibility Study
Official title: NIRS Directed Optimal Cerebral Perfusion Pressure in Septic Shock Patients: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: The Time Used for Determining Optimal CPP
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (age ≥ 18 years) septic shock patients admitted to ICU because of septic shock and predicted to stay in ICU ≥ 24 hours.

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 range.The 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 ORI/THx 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years;
2. Admitted to ICU because of septic shock. The diagnostic criteria of sepsis 3.0 was according to the jointly issued definition by the American Association of Critical Care Medicine and the European Society of Critical Care Medicine.
3. Predicted to stay in ICU ≥ 24 hours

Exclusion Criteria:

1. Unable to perform NIRS monitoring because of anatomic factors: such as forehead skin damage, intracranial gas accumulation, severe edema of monitoring sites;
2. Patients with severe organ failure: such as poorly controlled chronic hypertension, chronic renal failure.

Primary outcomes:
measure: Optimal CPP
timeFrame: 16 hours
Secondary outcomes:
Other outcomes:
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