Etiology and Hemodynamic Instability in Brain Death

NCT ID: NCT06569992

Last Updated: 2025-02-07

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

Total Enrollment

216 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-30

Study Completion Date

2024-12-30

Brief Summary

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Brain death is a complex and irreversible condition marked by the cessation of all brain activity. This retrospective study analyzes ICU patients who progressed from initial brain injury to brain death. The research focuses on demographic profiles, pharmacological interventions, laboratory data, and imaging findings to understand these cases clinical trajectories and therapeutic responses. Central to this study is evaluating cardiovascular support using the Vasoactive-Inotropic Score (VIS) and Total Inotrope Exposure (TIE) Score. This study explores the relationship between the etiology of brain death and the pharmacologic cardiovascular support administered, as quantified by VIS and TIES scores. This study seeks to enhance the management strategies and improve outcomes for patients diagnosed with brain death

Detailed Description

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This study undertakes a comprehensive retrospective analysis of patients admitted to the intensive care unit (ICU) with an initial diagnosis of brain injury who subsequently progressed to brain death. The investigation will meticulously assess these patients, demographic profiles, pharmacological interventions, laboratory parameters, and radiological imaging findings. The overarching aim is to delineate the clinical trajectory and therapeutic responses of patients diagnosed with brain death, critically evaluating the complexities encountered during their management, and providing evidence-based insights to inform future treatment protocols.

Central to this study is the quantitative assessment of hemodynamic stability using the Vasoactive-Inotropic Score (VIS) and the Total Inotrope Exposure (TIE) Score. The VIS will quantify the need for vasopressor and inotropic support, reflecting the severity of cardiovascular instability. At the same time, the TIE Score will measure the cumulative exposure to inotropic agents, providing a comprehensive evaluation of the overall cardiovascular burden. The primary aim of this study is to explore the relationship between the etiology of brain death and the pharmacologic cardiovascular support administered, as quantified by VIS and TIES scores. Additionally, the study will assess how these pharmacologic interventions differ in patients who have undergone decompressive surgery compared to those who have not.

This thesis aspires to make a significant contribution to the optimization of management strategies for patients diagnosed with brain death, aiming to enhance clinical decision-making and improve patient outcomes in this critically ill cohort.

Conditions

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Brain Death

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

Spontaneous subarachnoid hemorrhage and spontaneous intracerebral hemorrhage

VIS, TIES

Intervention Type OTHER

The vasopressor and inotropic drug dosages administered during the follow-up of these patients will be recorded, and the Vasoactive-Inotropic Score (VIS) and Total Inotrope Exposure Score (TIES) will be calculated.

Group 2

Traumatic intracranial hemorrhage

VIS, TIES

Intervention Type OTHER

The vasopressor and inotropic drug dosages administered during the follow-up of these patients will be recorded, and the Vasoactive-Inotropic Score (VIS) and Total Inotrope Exposure Score (TIES) will be calculated.

Group 3

Ischemic cerebrovascular events and hypoxic-ischemic brain injury (including cases of cardiac arrest, drowning, carbon monoxide poisoning, etc.)

VIS, TIES

Intervention Type OTHER

The vasopressor and inotropic drug dosages administered during the follow-up of these patients will be recorded, and the Vasoactive-Inotropic Score (VIS) and Total Inotrope Exposure Score (TIES) will be calculated.

Interventions

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VIS, TIES

The vasopressor and inotropic drug dosages administered during the follow-up of these patients will be recorded, and the Vasoactive-Inotropic Score (VIS) and Total Inotrope Exposure Score (TIES) will be calculated.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients (≥18 years) admitted to the intensive care unit (ICU) at Antalya Training and Research Hospital between 2019 and 2023.
* Patients with a confirmed diagnosis of brain death based on a positive apnea test and/or neuroimaging findings.
* Patients with comprehensive and complete clinical data available in the hospital\'s medical records.

Exclusion Criteria

* Patients under the age of 18.
* Patients with incomplete clinical data in the medical records.
* Patients with moderate to severe heart failure.
* Patients with major organ injuries in addition to traumatic intracranial hemorrhage.
* Pregnant patients.
* Patients with significant comorbidities that could impact hemodynamic stability.
* Patients experiencing hemodynamic instability due to septic shock.
* Patients who were initially treated for brain injury at external facilities and later transferred to our hospital.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Nilgun Kavrut Ozturk

Professor MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nilgun Kavrut Ozturk, Professor

Role: STUDY_CHAIR

University of Health Science Antalya Training and Research Hospital

Locations

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University of Health Sciences

Antalya, Muratpasa, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Flowers WM Jr, Patel BR. Persistence of cerebral blood flow after brain death. South Med J. 2000 Apr;93(4):364-70.

Reference Type RESULT
PMID: 10798503 (View on PubMed)

Belletti A, Lerose CC, Zangrillo A, Landoni G. Vasoactive-Inotropic Score: Evolution, Clinical Utility, and Pitfalls. J Cardiothorac Vasc Anesth. 2021 Oct;35(10):3067-3077. doi: 10.1053/j.jvca.2020.09.117. Epub 2020 Sep 22.

Reference Type RESULT
PMID: 33069558 (View on PubMed)

Other Identifiers

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2024-CeylanM.Braindeath

Identifier Type: -

Identifier Source: org_study_id

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