Etiology and Hemodynamic Instability in Brain Death

February 5, 2025 updated by: Nilgun Kavrut Ozturk, Antalya Training and Research Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

216

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Muratpasa
      • Antalya, Muratpasa, Turkey, 07100
        • University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Spontaneous subarachnoid hemorrhage and spontaneous intracerebral hemorrhage
Other: 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.
Group 2
Traumatic intracranial hemorrhage
Other: 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.
Group 3
Ischemic cerebrovascular events and hypoxic-ischemic brain injury (including cases of cardiac arrest, drowning, carbon monoxide poisoning, etc.)
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Inotrope Exposure Score (TIES)
Time Frame: 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
From beginning to vasoactive-inotropic drugs infusion until diagnosis of brain death, 10 days (with intermediate measurements every hours)
Vasoactive-Inotropic Score (VIS)
Time Frame: 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).
From beginning to vasoactive-inotropic drugs infusion until diagnosis of brain death, 10 days (with intermediate measurements every hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Training and Research Hospital

Investigators

  • Study Chair: Nilgun Kavrut Ozturk, Professor, University of Health Science Antalya Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2024

Primary Completion (Actual)

October 30, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-CeylanM.Braindeath

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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