- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04683094
Comparative Study for the Validity of Various Severity Scoring System
January 27, 2022 updated by: Huda Fahmy Mahmoud, PhD, Aswan University Hospital
Comparative Study for the Validity of Various Severity Scoring System in the Surgical Intensive Care Unit at Aswan University Hospital
Scoring systems for use in intensive care unit (ICU) patients have been introduced and developed over the last 30 years.
They allow an assessment of the severity of disease and provide an estimate of in-hospital mortality
Study Overview
Status
Completed
Conditions
Detailed Description
Severity scoring systems that are commonly used in critical care settings include Acute Physiology and Chronic Health Evaluation (APACHE), which was developed in the 1980s for predicting mortality, Simplified Acute Physiology Score (SAPS), and Mortality Probability Model (MPM).
Although these scoring systems use different variables and weights for the classification of disease severity, they commonly monitor parameters such as heart rate, blood pressure, neurological state, and clinical data as these factors significantly deviate from physiological normality in the progression of critical disease.
Old age and chronic disease are also captured by the scoring systems.
Sequential Organ Failure Assessment (SOFA) score, which is based on organ failure over time to evaluate morbidity and multiple organ dysfunction is also used.
Study Type
Observational
Enrollment (Actual)
200
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
-
-
-
Aswan, Egypt, 81511
- Huda Fahmy
-
-
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
16 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
newly admitted patients to the Surgical Intensive Care Unit at Aswan University Hospital
Description
Inclusion Criteria:
- newly admitted patients to the Surgical Intensive Care Unit with head trauma multiple trauma craniotomy sepsis preeclampsia - eclampsia postop. for vascular surgery
Exclusion Criteria:
less than 16 years old, readmitted to the ICU during the study period as only the first admission will be considered, ICU length of stay (LOS) less than 24 h
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 |
Time Frame |
|---|---|
|
Acute Physiology and Chronic Health Evaluation (APACHE) IV
Time Frame: the first 24 hours after ICU admission
|
the first 24 hours after ICU admission
|
|
Simplified Acute Physiology Score (SAPS III)
Time Frame: the first 24 hours after ICU admission
|
the first 24 hours after ICU admission
|
|
Sequential Organ Failure Assessment (SOFA) score
Time Frame: the first 24 hours after ICU admission
|
the first 24 hours after ICU admission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: huda fahmy, Aswan University
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)
April 1, 2020
Primary Completion (Actual)
December 30, 2021
Study Completion (Actual)
December 30, 2021
Study Registration Dates
First Submitted
December 20, 2020
First Submitted That Met QC Criteria
December 20, 2020
First Posted (Actual)
December 24, 2020
Study Record Updates
Last Update Posted (Actual)
January 31, 2022
Last Update Submitted That Met QC Criteria
January 27, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 449/3/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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