- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06490640
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
Status
Completed
Conditions
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
-
-
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Antalya, Turkey
- Akdeniz University School of Medicine, Department of Anesthesiology and Intensive Care, Turkey
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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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Akdeniz U.
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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