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临床试验/NCT06569992
NCT06569992已完成不适用

Comparison of the Relationship Between Etiology and Hemodynamic Instability in Brain Death: VIS and TIES

Antalya Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2024年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
216
试验地点
1
主要终点
Vasoactive-Inotropic Score (VIS)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (≥18 years) admitted to the intensive care unit (ICU) at Antalya Training and Research Hospital between 2019 and
  • 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.

排除标准

  • Patients under the age of
  • 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.

结局指标

主要结局

Vasoactive-Inotropic Score (VIS)

时间窗: From beginning to vasoactive-inotropic drugs infusion until diagnosis of brain death, 10 days (with intermediate measurements every hours)

Dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 × epinephrine dose (μg/kg/min) + 10 × milrinone dose (μg/kg/min) + 10 000 × vasopressin dose (unit/kg/min) + 100 × norepinephrine dose (μg/kg/min).

Total Inotrope Exposure Score (TIES)

时间窗: From beginning to vasoactive-inotropic drugs infusion until diagnosis of brain death, 10 days (with intermediate measurements every hours)

Dopamine dose (μg/kg/min) × \[length of administration in days\] + Dobutamine dose (μg/kg/min) × \[length of administration in days\] + 10 × Milrinone dose (μg/kg/min) × \[length of administration in days\] + 100 × Epinephrine dose (μg/kg/min) × \[length of administration in days\] + 100 × Norepinephrine dose (μg/kg/min) × \[length of administration in days\] + 10,000 × Vasopressin dose (U/kg/min) × \[length of administration in days

次要结局

未报告次要终点

研究者

发起方
Antalya Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Nilgun Kavrut Ozturk

Professor MD

Antalya Training and Research Hospital

研究点 (1)

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Etiology and Hemodynamic Instability in Brain Death | 临床试验