Validation of the SD-ICU. A Risk Assessment Tool of Unplanned ICU Readmission

Critical Illness Clinical Trial

Official title:

Assessment of the Risk of Unplanned Readmission to the Intensive Care Unit Using the Safe Discharge From ICU (SD-ICU) Score: A Validation Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02330874
• Other study ID #: 003/2014
• Status: Active, not recruiting
• Phase: N/A
• First received: December 28, 2014
• Last updated: January 2, 2015
• Start date: April 2014
• Est. completion date: September 2015

Study information

• Verified date: December 2014
• Source: Hospital Sao Domingos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

In a recent study, which included 845 patients that at the time of ICU discharge had at least one risk factor for readmission, the investigators' group developed a new readmission risk score in the ICU, Safe Discharge from ICU (SD-ICU), using parameters easily and routinely measured in ICU: the Charlson comorbidity (ICC), the TISS-28 (Therapeutic Intervention Scoring System - 28), the length of stay in ICU and age. Through ROC curve analysis, the investigators found that patients with a score above 14.5 had a high probability of readmission.

The objective of this study is to validate the Safe Discharge from ICU (SD-ICU) score as a tool to predict unplanned readmissions to the intensive care unit.

All adult patients discharged from a 37 bed general ICU from April 2014 to March 2015 will be included in the study. The SD-ICU score is routinely calculated at the time of discharge from the ICU. Patients will be divided into two groups: those with SD-ICU score> 14.5 (group 1) and those with a score equal to or less than 14.5 (group 2). The two groups will be compared with respect to the frequency of unplanned readmissions. Stepwise, multivariate logistic regression will be used to investigate the association between the risk factors for readmission used in SD-ICU score and ICU readmission as outcome.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: September 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients discharged from a general ICU

Exclusion Criteria:

• Patients under 18 years old

• Those that were not candidates for ICU readmission (interhospital and home care transfer)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
Brazil	Hospital Sao Domingos	Sao Luis	Maranhao

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Domingos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmission to the ICU		After ICU discharge	No