Clinical trial NCT06569992: Etiology and Hemodynamic Instability in Brain Death
Official title: Comparison of the Relationship Between Etiology and Hemodynamic Instability in Brain Death: VIS and TIES
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Death
Keywords: Brain death
VIS
TIES
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-26
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will retrospectively analyze data from patients diagnosed with brain death and followed in the Anesthesiology and Intensive Care Units at University of Health Science Antalya Training and Research Hospital between January 1, 2019, and December 31, 2023. Patients will be categorized based on the etiological cause of brain injury into the following groups: those with spontaneous subarachnoid hemorrhage and spontaneous intracerebral hemorrhage (Group 1), those with traumatic intracranial hemorrhage (Group 2), and those with ischemic cerebrovascular events and hypoxic-ischemic brain injury (including cases of cardiac arrest, drowning, carbon monoxide poisoning, etc.) (Group 3).

Brief summary: 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: 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.

Eligibility criteria: 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\&amp;#39;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.

Primary outcomes:
measure: Total Inotrope Exposure Score (TIES)
timeFrame: From beginning to vasoactive-inotropic drugs infusion until diagnosis of brain death, 10 days (with intermediate measurements every hours)
measure: Vasoactive-Inotropic Score (VIS)
timeFrame: From beginning to vasoactive-inotropic drugs infusion until diagnosis of brain death, 10 days (with intermediate measurements every hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: University of Health Sciences
state: Muratpasa
Study officials:
affiliation: University of Health Science Antalya Training and Research Hospital
name: Nilgun Kavrut Ozturk, Professor
role: STUDY_CHAIR
References:
citation: Flowers WM Jr, Patel BR. Persistence of cerebral blood flow after brain death. South Med J. 2000 Apr;93(4):364-70.
citation: 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.