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Completed

NCT Number: NCT05842616

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

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.

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Key information

Conditions

Sepsis Brain Diseases Central Nervous System Diseases Encephalopathy Infections Inflammation Nervous System Diseases Norepinephrine Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, Elgharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Transcranial doppler pulsatility index guided protocol

Other

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

Mean arterial blood pressure guided protocol

Other

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

Primary outcomes

  1. Intensive care unit (ICU) mortality

    Time frame: 28 day or till death which earlier

    Incidence of Intensive care unit (ICU) stay will be recorded

Secondary outcomes

  1. Mean arterial pressure

    Time frame: 24 hours

    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).

  2. Norepinephrine titration

    Time frame: 24 hours

    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).

  3. Cerebral perfusion pressure

    Time frame: 24 hours

    Cerebral perfusion pressure (CPP) will be done using transcranial doppler.

  4. Outcome of encephalopathy

    Time frame: 28 day

    Encephalopathy outcome at ICU discharge using Glasgow coma scale (GCS)

  5. SOFA score

    Time frame: Up to 4 weeks.

    SOFA score at ICU admission and discharge.

  6. Length of ICU stay

    Time frame: At least 28 days

    Length of ICU stay

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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