- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06354426
Short-term Mortality Prediction by the SOFA Score in Acute Decompensated Heart Failure
April 5, 2024 updated by: Hanoi Heart Hospital
Short-term Mortality and Readmission Rate Prediction by the Sequential Organ Failure Assessment Score in Acute Decompensated Heart Failure
Data on the use of sequential organ failure assessment (SOFA) in patients with cardiovascular disease are increasing.
Several studies demonstrated that the SOFA score can identify short-term mortality in patients with acute decompensated heart failure (ADHF).
This study was conducted to determine the prognostic value of the admission SOFA score in patients hospitalised for ADHF and to assess its ability in predicting the 30-day readmission rate.
Study Overview
Status
Completed
Conditions
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
-
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Hoan Kiem
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Hanoi, Hoan Kiem, Vietnam, 110000
- Hanoi Heart Hospital
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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
This was a single-centre, prospective study conducted from July 2022 to August 2023 at Hanoi Heart Hospital (Hanoi, Vietnam).
Description
Inclusion Criteria:
- All patients over 18 years old who were hospitalised for acute heart failure were included (either new-onset acute heart failure or ADHF).
Exclusion Criteria:
- Patients with septic shock or pulmonary infarction were excluded.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: Within 30 days from the day of hospitalization
|
The sequential organ failure assessment (SOFA) score was used to assess the relation to the all cause mortality of the patient with acute decompensated heart failure.
Higher SOFA score is correlated with higher in-hospital mortality rate and 30-day mortality regardless of age, gender, or other comorbidities.
|
Within 30 days from the day of hospitalization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Re-admission rate
Time Frame: Within 30 days
|
To assess the prediction ability of the sequential organ failure assessment (SOFA) score in regard of re-admission rate.
|
Within 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 1, 2022
Primary Completion (Actual)
August 31, 2023
Study Completion (Actual)
August 31, 2023
Study Registration Dates
First Submitted
March 30, 2024
First Submitted That Met QC Criteria
April 5, 2024
First Posted (Actual)
April 9, 2024
Study Record Updates
Last Update Posted (Actual)
April 9, 2024
Last Update Submitted That Met QC Criteria
April 5, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BVT2022/01
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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