Etiology and Hemodynamic Instability in Brain Death

NCT06569992 | Completed

• 1 other identifier: 2024-CeylanM.Braindeath
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

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

Conditions

Brain Death

Keywords

Brain death; VIS; TIES

Outcome Measures

Primary Outcomes (2)

• Total Inotrope Exposure Score (TIES)

  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)

  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)

Study Arms (3)

Group 1

Spontaneous subarachnoid hemorrhage and spontaneous intracerebral hemorrhage

Other: VIS, TIES

Group 2

Traumatic intracranial hemorrhage

Other: VIS, TIES

Group 3

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

Other: VIS, TIES

Interventions

VIS, TIES 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 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences

Antalya, Muratpasa, 07100, Turkey (Türkiye)

Location

Related Publications (2)

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

  PMID: 10798503 RESULT

• 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.

  PMID: 33069558 RESULT

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nilgun Kavrut Ozturk, Professor

  University of Health Science Antalya Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 26, 2024
• Study Start: May 30, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)