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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Encephalopathy; Norepinephrine
• Intervention / Treatment: Other: Transcranial doppler pulsatility index guided protocol; Other: Mean arterial blood pressure guided protocol

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.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mai S Aboshaara, MD; Phone Number: +201061107658; Email: dr_mai.s.salem91@hotmail.com

Study Locations

• Egypt
  • Elgharbia
    • Tanta, Elgharbia, Egypt, 31527
      • Recruiting
      • Tanta University hospitals
      • Contact: Mai S Aboshaara, MSc; Phone Number: +201061107658; Email: dr_mai.s.salem91@hotmail.com
      • Sub-Investigator: Salah Eldeen I Alsherif, MD
      • Sub-Investigator: Hala M El-Gendy, MD
      • Sub-Investigator: Mohamed S Abd El Ghafar, MD
      • Sub-Investigator: Motaz A Abosabaa, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Mai S Aboshaara, MD, Assistant lecturer

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: April 15, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Brain Diseases
• Other Study ID Numbers: 35559/6/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No