Cerebral Pulsatility Index Compared To Mean Arterial Blood Pressure Guided Protocol In Sepsis Induced Encephalopathy:

Study Overview
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Brief Summary
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The aim of our study is to compare between transcranial doppler pulsatility index and mean arterial blood pressure in guiding management of sepsis induced encephalopathy.

Detailed Description
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Sepsis induced encephalopathy is the most frequent sepsis related organ dysfunction. It appears early during the course of infection, often before any other organ involvement in up to 70% of hospitalized septic patients and is associated with significant change of cerebral circulation caused by redistribution of blood flow during sepsis that accompanies the abnormal inflammatory response during an infection, in absence of direct central nervous system involvement.

Official Title
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Norepinephrine Titration In Patients With Sepsis Induced Encephalopathy: Cerebral Pulsatility Index Compared To Mean Arterial Blood Pressure Guided Protocol

Conditions
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Sepsis, Norepinephrine, Encephalopathy

Intervention / Treatment
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* Other: Transcranial doppler pulsatility index guided protocol
* Other: Mean arterial blood pressure guided protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years or older Must had clinical diagnosis of sepsis induced encephalopathy. Exclusion Criteria: Refusal to participate in the study. Cerebral infection. Known cerebral lesions (Neoplasm, Traumatic brain injury, Stroke, Ischemic or hemorrhagic cerebrovascular lesions, high intracranial pressure). Known severe carotid stenosis (>70％). Intoxication due to drugs. Pregnancy. Patients supported by intra-aortic balloon pumb (IABP).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial doppler pulsatility index guided protocol<br>Norepinephrine titration that will be guided by Transcranial doppler (TCD) pulsatility index. | Other: Transcranial doppler pulsatility index guided protocol<br>* Norepinephrine titration that will be guided by Transcranial doppler pulsatility index.<br>|
| Active Comparator: Mean arterial blood pressure guided protocol<br>Norepinephrine titration that will be guided by Mean arterial blood pressure (MAP). | Other: Mean arterial blood pressure guided protocol<br>* Norepinephrine titration that will be guided by Mean arterial blood pressure (MAP).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive care unit (ICU) mortality | Incidence of Intensive care unit (ICU) stay will be recorded | 28 day or till death which earlier | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial pressure | Fluid resuscitation will be started using crystalloids at a rate of 4 to 6 ml/kg with reevaluation after 15 minutes. If MAP is still less than 65 mmhg, fluid resuscitation should be continued at a rate of 4 to 6 ml/kg with reevaluation after another 15 minutes up to 30 ml/kg. Vasopressors will be started if the patient is still hypotensive during or after resuscitation without delay even peripherally to avoid delay until central venous access is secured (norepinephrine is the first line agent preferred over other vasopressors). | 24 hours | 
| Norepinephrine titration | Fluid resuscitation will be started using crystalloids at a rate of 4 to 6 ml/kg with reevaluation after 15 minutes. If MAP is still less than 65 mmhg, fluid resuscitation should be continued at a rate of 4 to 6 ml/kg with reevaluation after another 15 minutes up to 30 ml/kg. Vasopressors will be started if the patient is still hypotensive during or after resuscitation without delay even peripherally to avoid delay until central venous access is secured (norepinephrine is the first line agent preferred over other vasopressors). | 24 hours | 
| Cerebral perfusion pressure | Cerebral perfusion pressure (CPP) will be done using transcranial doppler. | 24 hours | 
| Outcome of encephalopathy | Encephalopathy outcome at ICU discharge using Glasgow coma scale (GCS) | 28 day | 
| SOFA score | SOFA score at ICU admission and discharge. | Up to 4 weeks. | 
| Length of ICU stay | Length of ICU stay | At least 28 days |