Factors Influencing the Mortality of Patients With Subarachnoid Haemorrhage

June 29, 2024 updated by: Melike Cengiz

Factors Influencing the Mortality of Patients With Subarachnoid Haemorrhage in the Intensive Care Unit

Spontaneous subarachnoid haemorrhage (SAH) is a serious cerebrovascular disease with high morbidity and mortality.Determining the factors associated with mortality in the ICU follow-up and treatment of patients with spontaneous SAH is very important for clarifying these uncertainties and improving ICU outcomes.In the literature, there are very few studies analysing ICU mortality and mortality-related factors in this patient group.The aim of this study was to determine the demographic/clinical characteristics and factors affecting the mortality of spontaneous SAH patients admitted in the ICU.

Study Overview

Detailed Description

Patients aged 18 years and older who were diagnosis of spontaneous SAH and admitted the ICU were included in the study. The diagnosis of spontaneous SAH was based on the brain computed tomography (CT) or lumbar puncture. Patients with a final outcome (survival or mortality) in our centre were included in the analysis were included. Only patients admitted to the ICU for the first time were included. Patients with traumatic SAH, history of significant head trauma in the previous two weeks (any abnormality on brain CT requiring hospitalisation for more than 24 hours), pregnancy and length of ICU stay ≤24 hours were excluded.The clinical and radiological severity of the patients at ICU admission was according to Acute Physiological and Chronic Health Evaluation-II score (APACHE II), Glasgow Coma Scale (GCS), Modified Fisher Scale, World Federation of Neurological Societies (WFNS) and Hunt and Hess (H&H) grading systems.Demographic and clinical data derived and analyzed included age, sex, smoking history, comorbidities. Presenting signs and symptoms, diagnoses responsible for spontaneous SAH (aneurysm, arterial malformation, etc.), site of aneurysm, risk factors, location of the aneurysm, risk factors, blood pressure during ICU admission, and scores from grading systems indicating clinical and radiological severity of the disease were recorded. Procedures for spontaneous SAH, complications during ICU follow-up (vasospasm, meningitis, electrolyte disturbances, rebleeding, DCI, VIP, sepsis/septic shock) and treatments, duration of ICU stay and mechanical ventilation, ICU outcome (survival or mortality), causes of mortality and brain death status were recorded. According to the outcome of the ICU process, the patients were divided into two groups as survival and mortality.

Study Type

Observational

Enrollment (Actual)

117

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

      • Antalya, Turkey
        • Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey

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

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 years and older who were diagnosis of spontaneous SAH and admitted the intensive care unit were included in the study.

Description

Inclusion Criteria:

  • Patients aged ≥18 years with a confrmed diagnosis of spontaneous subarachnoid haemorrhage by a brain computed tomography (CT)
  • Patients with a final outcome (survival or mortality) in our centre

Exclusion Criteria:

  • Patients with traumatic SAH
  • History of significant head trauma in the previous two weeks (any abnormality on brain CT requiring hospitalisation for more than 24 hours)
  • Pregnancy
  • Length of intensive care unit stay ≤24 hours

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
Spontaneous subarachnoid haemorrhage survival cohort
Demographic and clinical data derived and analyzed included age, sex, smoking history, comorbidities. Presenting signs and symptoms, diagnoses responsible for spontaneous SAH (aneurysm, arterial malformation, etc.), site of aneurysm, risk factors, location of the aneurysm, risk factors, blood pressure during ICU admission, and scores from grading systems indicating clinical and radiological severity of the disease were recorded. Procedures for spontaneous SAH, complications during ICU follow-up (vasospasm, meningitis, electrolyte disturbances, rebleeding, DCI, VIP, sepsis/septic shock) and treatments, duration of ICU stay and mechanical ventilation, ICU outcome (survival or mortality), causes of mortality and brain death status were recorded.
consists of surviving patients
Spontaneous subarachnoid haemorrhage mortality cohort
Demographic and clinical data derived and analyzed included age, sex, smoking history, comorbidities. Presenting signs and symptoms, diagnoses responsible for spontaneous SAH (aneurysm, arterial malformation, etc.), site of aneurysm, risk factors, location of the aneurysm, risk factors, blood pressure during ICU admission, and scores from grading systems indicating clinical and radiological severity of the disease were recorded. Procedures for spontaneous SAH, complications during ICU follow-up (vasospasm, meningitis, electrolyte disturbances, rebleeding, DCI, VIP, sepsis/septic shock) and treatments, duration of ICU stay and mechanical ventilation, ICU outcome (survival or mortality), causes of mortality and brain death status were recorded.
consists of deceased patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determine mortality and causes
Time Frame: 01 January 2019-31 December 2023
determine mortality and its causes in patients with spontaneous subarachnoid haemorrhage
01 January 2019-31 December 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
factors affecting mortality
Time Frame: 01 January 2019-31 December 2023
evaluate the clinical characteristics and factors affecting mortality in subarachnoid haemorrhage
01 January 2019-31 December 2023

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Ulku Arslan Yildiz, MD, Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
  • Principal Investigator: Murat Yilmaz, Professor, Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
  • Principal Investigator: Onur Cetinkaya, MD, Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey

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)

March 1, 2024

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

June 15, 2024

Study Registration Dates

First Submitted

June 29, 2024

First Submitted That Met QC Criteria

June 29, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 8, 2024

Last Update Submitted That Met QC Criteria

June 29, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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