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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03967041
Other study ID # 106-4283C
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date April 15, 2019

Study information

Verified date May 2019
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Sarcopaenia is associated with poor prognoses of in-hospital mortality in splenic abscess patients. Investigators recommend its use by surgeons in the ED to rapidly risk stratify and identify patients requiring urgent and aggressive intervention, to maximise patient outcomes and survival chances.


Description:

Splenic abscess is a life-threatening surgical emergency which requires early diagnosis and intervention to maximise patient outcomes. This can be achieved through accurate risk stratification in the emergency department (ED). Sarcopaenia refers to an age-related loss of skeletal muscle mass and strength with major physiologic and clinical ramifications. This study evaluates sarcopaenia as a radiological risk stratification tool to predict in-hospital mortality of splenic abscess patients.

99 adult patients at four training and research hospitals who had undergone abdominal contrast CT scans in the ED with the final diagnosis of splenic abscess from January 2005 to December 2015 were recruited. Evaluation for sarcopaenia was performed via calculating psoas cross-sectional area at level of L3 and normalising for height. Univariate analyses were used to evaluate the differences between survivors and non-survivors, with subsequent logistic regression analysis to assess odds ratio of sarcopaenia with respect to in-hospital mortality. A receiver operating characteristic (ROC) curve was plotted to determine predictability of sarcopaenia, with its corresponding sensitivity, specificity, and accuracy rate calculated.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date April 15, 2019
Est. primary completion date March 30, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

All adult patients older than 20 years of age admitted to the aforementioned hospitals who had undergone an abdominal contrast CT scan in the ED with the final diagnosis of splenic abscess from January 2005 to December 2015

Exclusion Criteria:

Patients who could not be assessed for sarcopaenia in line with our study methodology and/or had other coexisting infections were excluded. Patients with abscesses involving the psoas muscles were also excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
radiological defined sarcopenia
Evaluation for sarcopaenia was performed via calculating psoas cross-sectional area at level of L3 and normalising for height

Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality In-hospital mortality during hospitalization Up to 12 weeks
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