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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05842616
Enrollment
112
Registered
2023-05-06
Start date
2023-05-01
Completion date
2024-06-30
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Encephalopathy, Norepinephrine, Sepsis

Brief summary

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

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.

Interventions

OTHERTranscranial doppler pulsatility index guided protocol

Norepinephrine titration that will be guided by Transcranial doppler pulsatility index.

OTHERMean arterial blood pressure guided protocol

Norepinephrine titration that will be guided by Mean arterial blood pressure (MAP).

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Intensive care unit (ICU) mortality28 day or till death which earlierIncidence of Intensive care unit (ICU) stay will be recorded

Secondary

MeasureTime frameDescription
Outcome of encephalopathy28 dayEncephalopathy outcome at ICU discharge using Glasgow coma scale (GCS)
SOFA scoreUp to 4 weeks.SOFA score at ICU admission and discharge.
Length of ICU stayAt least 28 daysLength of ICU stay
Norepinephrine titration24 hoursFluid 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).
Cerebral perfusion pressure24 hoursCerebral perfusion pressure (CPP) will be done using transcranial doppler.
Mean arterial pressure24 hoursFluid 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).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026