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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04683094
Other study ID # 449/3/20
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date December 30, 2021

Study information

Verified date January 2022
Source Aswan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers
Gender All
Age group 16 Years to 80 Years
Eligibility 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 Design


Locations

Country Name City State
Egypt Huda Fahmy Aswan

Sponsors (1)

Lead Sponsor Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acute Physiology and Chronic Health Evaluation (APACHE) IV the first 24 hours after ICU admission
Primary Simplified Acute Physiology Score (SAPS III) the first 24 hours after ICU admission
Primary Sequential Organ Failure Assessment (SOFA) score the first 24 hours after ICU admission
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