Back to resultsCerebral Pulsatility Index Compared To Mean Arterial Blood Pressure Guided Protocol In Sepsis Induced Encephalopathy:
Primary Purpose
Sepsis, Norepinephrine, Encephalopathy
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Transcranial doppler pulsatility index guided protocol
Mean arterial blood pressure guided protocol
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis
Eligibility Criteria
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).
Sites / Locations
- Tanta University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transcranial doppler pulsatility index guided protocol
Mean arterial blood pressure guided protocol
Arm Description
Norepinephrine titration that will be guided by Transcranial doppler (TCD) pulsatility index.
Norepinephrine titration that will be guided by Mean arterial blood pressure (MAP).
Outcomes
Primary Outcome Measures
Intensive care unit (ICU) mortality
Incidence of Intensive care unit (ICU) stay will be recorded
Secondary Outcome Measures
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).
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).
Cerebral perfusion pressure
Cerebral perfusion pressure (CPP) will be done using transcranial doppler.
Outcome of encephalopathy
Encephalopathy outcome at ICU discharge using Glasgow coma scale (GCS)
SOFA score
SOFA score at ICU admission and discharge.
Length of ICU stay
Length of ICU stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05842616
Brief Title
Cerebral Pulsatility Index Compared To Mean Arterial Blood Pressure Guided Protocol In Sepsis Induced Encephalopathy:
Official Title
Norepinephrine Titration In Patients With Sepsis Induced Encephalopathy: Cerebral Pulsatility Index Compared To Mean Arterial Blood Pressure Guided Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Norepinephrine, Encephalopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcranial doppler pulsatility index guided protocol
Arm Type
Experimental
Arm Description
Norepinephrine titration that will be guided by Transcranial doppler (TCD) pulsatility index.
Arm Title
Mean arterial blood pressure guided protocol
Arm Type
Active Comparator
Arm Description
Norepinephrine titration that will be guided by Mean arterial blood pressure (MAP).
Intervention Type
Other
Intervention Name(s)
Transcranial doppler pulsatility index guided protocol
Intervention Description
Norepinephrine titration that will be guided by Transcranial doppler pulsatility index.
Intervention Type
Other
Intervention Name(s)
Mean arterial blood pressure guided protocol
Intervention Description
Norepinephrine titration that will be guided by Mean arterial blood pressure (MAP).
Primary Outcome Measure Information:
Title
Intensive care unit (ICU) mortality
Description
Incidence of Intensive care unit (ICU) stay will be recorded
Time Frame
28 day or till death which earlier
Secondary Outcome Measure Information:
Title
Mean arterial pressure
Description
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).
Time Frame
24 hours
Title
Norepinephrine titration
Description
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).
Time Frame
24 hours
Title
Cerebral perfusion pressure
Description
Cerebral perfusion pressure (CPP) will be done using transcranial doppler.
Time Frame
24 hours
Title
Outcome of encephalopathy
Description
Encephalopathy outcome at ICU discharge using Glasgow coma scale (GCS)
Time Frame
28 day
Title
SOFA score
Description
SOFA score at ICU admission and discharge.
Time Frame
Up to 4 weeks.
Title
Length of ICU stay
Description
Length of ICU stay
Time Frame
At least 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mai S Aboshaara, MD
Phone
+201061107658
Email
dr_mai.s.salem91@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai S Aboshaara, MD
Organizational Affiliation
Assistant lecturer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University Hospitals
City
Tanta
State/Province
Elgharbia
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mai S Aboshaara, MSc
Phone
+201061107658
Email
dr_mai.s.salem91@hotmail.com
First Name & Middle Initial & Last Name & Degree
Salah Eldeen I Alsherif, MD
First Name & Middle Initial & Last Name & Degree
Hala M El-Gendy, MD
First Name & Middle Initial & Last Name & Degree
Mohamed S Abd El Ghafar, MD
First Name & Middle Initial & Last Name & Degree
Motaz A Abosabaa, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Cerebral Pulsatility Index Compared To Mean Arterial Blood Pressure Guided Protocol In Sepsis Induced Encephalopathy:
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