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

NCT ID: NCT05842616

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Sepsis Norepinephrine Encephalopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transcranial doppler pulsatility index guided protocol

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

Group Type EXPERIMENTAL

Transcranial doppler pulsatility index guided protocol

Intervention Type OTHER

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).

Group Type ACTIVE_COMPARATOR

Mean arterial blood pressure guided protocol

Intervention Type OTHER

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

Interventions

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Transcranial doppler pulsatility index guided protocol

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

Intervention Type OTHER

Mean arterial blood pressure guided protocol

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

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mai Salah Salem

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mai S Aboshaara, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant lecturer

Locations

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Tanta University Hospitals

Tanta, Elgharbia, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 39755598 (View on PubMed)

Other Identifiers

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35559/6/22

Identifier Type: -

Identifier Source: org_study_id

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