investigate the effects of evidence-based ICU care on long-term outcomes of Sepsis or Septic Shock: the ILOSS Registry
Not Applicable
- Conditions
- Sepsis / Septic shock
- Registration Number
- JPRN-UMIN000041433
- Lead Sponsor
- Saiseikai Utsunomiya Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 350
Inclusion Criteria
Not provided
Exclusion Criteria
under 18 years the patients who had admitted to the ICU within one year under the same diagnosis of sepsis or septic shock the patients with COVID-19 the patients who are expected to discharge the ICU within 48 hours the patients whose diagnosis at the time of ICU admission was not sepsis or septic shock the patients with neurological dysfunction the patients who have difficulties to communicate with the medical staffs the patients who could not ambulate independently before the ICU admission end of care / terminal care
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcomes include survival, which is the most important outcome of this study, and the incidence of PICS defined as any of the following criteria: the presence of (1) physical impairments, (2) cognitive impairments, or (3) mental health disorders at 12-month follow-up
- Secondary Outcome Measures
Name Time Method The secondary outcomes are the scores of the assessments, such as EQ-5D-5L, EQ-VAS, BI, SMQ, HADS subset for anxiety or depression, and IES-R, the job-employment status, weight loss or recovery after hospital discharge, rehospitalization or readmission to ICU, and the necessity to visit the department of emergency medicine, rehabilitation, or psychiatric. The data on the incidence of PICS-F defined as mental health disorders of the family after the patients hospital discharge will be also collected