Long-term Recovery of Patients Admitted to the Intensive Care Unit
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Post Intensive Care Unit Syndrome
- Sponsor
- Medical Centre Leeuwarden
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Health-related Quality of Life
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Survival rates of patients with critical illness have increased due to improved facilities and treatment methods in the intensive care unit (ICU). Despite surviving critical illness, patients often face a difficult road of rehabilitation after discharge from the ICU or the hospital ward. A large body of evidence indicates that critical illness survivors suffer from physical and mental health problems, reflected in a reduced health related quality of life. However, detailed studies on longer-term outcomes and physical and mental recovery are lacking. In order to develop a tailored aftercare intervention program for critical care survivors a detailed description of the specific health problems is necessary. The aim of this study is to evaluate the change in health-related quality of life (HRQoL) and physical and mental health of critical illness survivors.
Detailed Description
Introduction Survival rates of patients with critical illness have increased due to improved facilities and treatment methods in the intensive care unit (ICU). Despite surviving critical illness, patients often face a difficult road of rehabilitation after discharge from the ICU or the hospital ward. A large body of evidence indicates that critical illness survivors suffer from physical and mental health problems, reflected in a reduced health related quality of life. However, detailed studies on longer-term outcomes and physical and mental recovery are lacking. In order to develop a tailored aftercare intervention program for critical care survivors a detailed description of the specific health problems is necessary. The aim of this study is to evaluate the change in health-related quality of life (HRQoL) and physical and mental health of critical illness survivors. Methods In this prospective single-center observational study 80 long-term ICU-patients will be included within six months. In addition to standard ICU care, the following measurements will be taken within 72 hours after ICU-admission: ultrasound measurements of the quadriceps, bioimpedance, plasma glutamine concentration and HRQoL using the RAND-36 item Health Survey (RAND-36). If the patient is unable to fill in the questionnaire, a proxy will be asked for this. The ultrasound, bioimpedance and plasma glutamine measurements will be repeated weekly in case the patient remains in ICU. When the patient is able to perform physical tests, hand grip strength and Morton Mobility Index measurements will be conducted weekly. After ICU-discharge, patients will be contacted by phone after 1,5, 4,5 and 9 months for an interview about dietary - and exercise habits. Furthermore, patients visit the specialised outpatient ICU clinic at 3, 6 and 12 months after ICU-discharge. Before this visit, patients will be asked to fill in a combination of questionnaires regarding mental health and HRQoL, specifically the RAND-36, the Hospital Anxiety and Depression Scale, the Short Fatigue Questionnaire, the Coping Inventory for Stressful Situations, the Trauma Screening Questionnaire, the Cognitive Failure Questionnaire and the Happiness Index. Secondly, blood samples are taken to measure c-reactive protein, hemoglobin, creatinine, albumin, glucose, glutamine, and biomarkers for mitochondrial dysfunction. Also, the following physical measures will be taken: bioimpedance measures, ultrasound of the quadriceps, hand grip strength, Morton Mobility Index, Barthel Index Score, Berg Balance Scale and the 6 minute walking test with pulse oximetry. Statistical analysis Variables will be summarised as, mean±standard deviation (SD), median \[interquartile range, IQR\] and number (percentage) for continuous or categorical variables, respectively. RAND-36 measures will be used to establish non-recovery patient groups. If appropriate, multivariate analyses will be conducted to identify risk factors with prognostic value for 1 year post-ICU recovery. Significance levels will be set at p\<0.05 for all analyses.
Investigators
E.C. Boerma
Dr.
Medical Centre Leeuwarden
Eligibility Criteria
Inclusion Criteria
- •Expected length of stay ICU ≥ 48 hours
Exclusion Criteria
- •Not applicable
Outcomes
Primary Outcomes
Health-related Quality of Life
Time Frame: Baseline, 3, 6 and 12 months
Change in HRQoL using the Dutch translation of the Research and Development-36 item Health Survey (RAND-36). This survey consists of nine subscales (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health perception and health change). Total subscale scores are reported with a range of 0 to 100 percent. Higher values represent a better outcome.
Secondary Outcomes
- Quadriceps muscle layer thickness(Baseline, 3, 6 and 12 months)
- Walking distance(3, 6 and 12 months)
- Changes in dietary and exercise pattern(1,5, 4,5 and 9 months)
- Blood creatinine concentration(Baseline, 3, 6 and 12 months)
- Blood albumin concentration(Baseline, 3, 6 and 12 months)
- Blood haemoglobin concentration(Baseline, 3, 6 and 12 months)
- Bioimpedance measurement in BIVA(Baseline, 3, 6 and 12 months)
- Hand grip strength(Baseline, 3, 6 and 12 months)
- physical activity(Baseline, 3, 6 and 12 months)
- Blood c-reactive protein concentration(Baseline, 3, 6 and 12 months)
- Blood glucose concentration(Baseline, 3, 6 and 12 months)
- Biomarkers for mitochondrial dysfunction(Baseline, 3, 6 and 12 months)
- Coping with stressful situations(3, 6 and 12 months)
- Blood glutamine concentration(Baseline, 3, 6 and 12 months)
- Depression(3, 6 and 12 months)
- Trauma(3, 6 and 12 months)
- Fatigue(3, 6 and 12 months)
- Subjective Happiness(3, 6 and 12 months)
- Cognitive functioning(3, 6 and 12 months)