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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842616
• Other study ID #: 35559/6/22
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2024
• Source: Tanta University
• Contact: Mai S Aboshaara, MD
• Phone: +201061107658
• Email: dr_mai.s.salem91[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Brain Diseases
• Encephalopathy
• Sepsis
• Toxemia

Intervention

Other:
• Transcranial doppler pulsatility index guided protocol
Norepinephrine titration that will be guided by Transcranial doppler pulsatility index.
• Mean arterial blood pressure guided protocol
Norepinephrine titration that will be guided by Mean arterial blood pressure (MAP).

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	Elgharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensive care unit (ICU) mortality	Incidence of Intensive care unit (ICU) stay will be recorded	28 day or till death which earlier
Secondary	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
Secondary	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
Secondary	Cerebral perfusion pressure	Cerebral perfusion pressure (CPP) will be done using transcranial doppler.	24 hours
Secondary	Outcome of encephalopathy	Encephalopathy outcome at ICU discharge using Glasgow coma scale (GCS)	28 day
Secondary	SOFA score	SOFA score at ICU admission and discharge.	Up to 4 weeks.
Secondary	Length of ICU stay	Length of ICU stay	At least 28 days