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

NCT05842616 | Completed

• 1 other identifier: 35559/6/22
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Norepinephrine; Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Intensive care unit (ICU) mortality

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

  28 day or till death which earlier

Secondary Outcomes (6)

• Mean arterial pressure

  24 hours

• Norepinephrine titration

  24 hours

• Cerebral perfusion pressure

  24 hours

• Outcome of encephalopathy

  28 day

• SOFA score

  Up to 4 weeks.

Study Arms (2)

Transcranial doppler pulsatility index guided protocol

EXPERIMENTAL

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

Other: Transcranial doppler pulsatility index guided protocol

Mean arterial blood pressure guided protocol

ACTIVE COMPARATOR

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

Other: Mean arterial blood pressure guided protocol

Interventions

Transcranial doppler pulsatility index guided protocol OTHER

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

Transcranial doppler pulsatility index guided protocol

Mean arterial blood pressure guided protocol OTHER

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

Mean arterial blood pressure guided protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older
• Must had clinical diagnosis of sepsis induced encephalopathy.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Elgharbia, 31527, Egypt

Location

Related Publications (1)

• Salem MS, Abosabaa MA, Abd El Ghafar MS, Ei-Gendy HMEM, Alsherif SEI. Norepinephrine titration in patients with sepsis-induced encephalopathy: cerebral pulsatility index compared to mean arterial pressure guided protocol: randomized controlled trial. BMC Anesthesiol. 2025 Jan 4;25(1):5. doi: 10.1186/s12871-024-02814-0.

  PMID: 39755598 DERIVED

MeSH Terms

Conditions

Sepsis; Brain Diseases

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mai S Aboshaara, MD

  Assistant lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: April 15, 2023
• First Posted: May 6, 2023
• Study Start: May 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)