NCT02330874

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 5, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 5, 2015

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

December 28, 2014

Last Update Submit

January 2, 2015

Conditions

Keywords

RiskscorereadmissionICU

Outcome Measures

Primary Outcomes (1)

  • Readmission to the ICU

    After ICU discharge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult patients discharged alive from a general ICU

You may qualify if:

  • Adult patients discharged from a general ICU

You may not qualify if:

  • Patients under 18 years old
  • Those that were not candidates for ICU readmission (interhospital and home care transfer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sao Domingos

São Luís, Maranhão, 65060-645, Brazil

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • JOSE R AZEVEDO, PhD

    Hospital Sao Domingos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 28, 2014

First Posted

January 5, 2015

Study Start

April 1, 2014

Primary Completion

March 1, 2015

Study Completion

September 1, 2015

Last Updated

January 5, 2015

Record last verified: 2014-12

Locations