Intensive Care Unit Recovery

Critical Illness Clinical Trial

— ICU-RE  

Official title:

Long-term Recovery of Patients Admitted to the Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04154995
• Other study ID #: RTPO 1055
• Status: Completed
• Start date: May 20, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2021
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Expected length of stay ICU = 48 hours

Exclusion Criteria:

• Not applicable

Related Conditions & MeSH terms

• Critical Illness
• Intensive Care Unit Acquired Weakness
• Post Intensive Care Unit Syndrome

Intervention

Diagnostic Test:
• Venipuncture
Blood testing at 3, 6 and 12 months
• Ultrasound Quadriceps Muscles
Ultrasound measurement of quadriceps muscle mass and health

Locations

Country	Name	City	State
Netherlands	Medical Center Leeuwarden	Leeuwarden	Friesland

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline demographic data	Age (yr), gender (male/female/other), height (cm), weight (kg), weight before ICU admission (kg), weight change (kg), health care utilization (average number of visits to a health care professional a month), living situation (number of household members), and work situation (paid job/volunteering job/no job + hours).	Baseline, 3, 6 and 12 months
Other	Clinical data during ICU stay from standard care	Standard care ICU-characteristics	Retrieved at 12 months from electronic patient data file
Primary	Health-related Quality of Life	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.	Baseline, 3, 6 and 12 months
Secondary	Quadriceps muscle layer thickness	Quadriceps ultrasound thickness measured in mm. Values below reference values indicate a worse outcome.	Baseline, 3, 6 and 12 months
Secondary	Bioimpedance measurement in BIVA	Bioimpedance measurements (baseline from standard care clinical data) measured using bioelectrical impedance vector analysis. Phase angle (degrees), reactance (Ohm) and resistance (Ohm) are measured. Fat free mass (kg) and total body water (l) are calculated using these measurements. Values above or below reference values indicate a worse outcome.	Baseline, 3, 6 and 12 months
Secondary	Hand grip strength	Hand grip strength test of the left and right hand in kg. Values below reference values indicate a worse outcome.	Baseline, 3, 6 and 12 months
Secondary	Walking distance	6-minute walk test measures are taken in meters. Values below reference values indicate a worse outcome.	3, 6 and 12 months
Secondary	physical activity	Morton Mobility Index scores are taken. This survey/physical test questionnaire consists of 15 questions with a scoring range of 0-19. A lower score indicates a worse outcome.	Baseline, 3, 6 and 12 months
Secondary	Blood c-reactive protein concentration	C-reactive protein (baseline from standard care clinical data) levels from blood samples in mg/L. Higher values indicate a worse outcome.	Baseline, 3, 6 and 12 months
Secondary	Blood creatinine concentration	Creatinine (baseline from standard care clinical data) levels from blood samples in µmol/L. Values below or above reference values indicate a worse outcome.	Baseline, 3, 6 and 12 months
Secondary	Blood haemoglobin concentration	Haemoglobin (baseline from standard care clinical data) levels from blood samples in mmol/L. Values below or above reference values indicate a worse outcome.	Baseline, 3, 6 and 12 months
Secondary	Blood albumin concentration	Albumin (baseline from standard care clinical data) levels from blood samples in g/L. Values below or above reference values indicate a worse outcome.	Baseline, 3, 6 and 12 months
Secondary	Blood glucose concentration	Glucose non fasting (baseline from standard care clinical data) from blood samples in mmol/l. Values below or above reference values indicate a worse outcome.	Baseline, 3, 6 and 12 months
Secondary	Blood glutamine concentration	Glutamine levels from blood samples in mmol/l. Values below reference values indicate a worse outcome.	Baseline, 3, 6 and 12 months
Secondary	Biomarkers for mitochondrial dysfunction	Levels of biomarkers for mitochondrial dysfunction from blood samples.	Baseline, 3, 6 and 12 months
Secondary	Fatigue	Change in subjective fatigue using the Dutch short-fatigue questionnaire/Verkorte Vermoeidheidsvragenlijst (VVV). This survey consists of 4 questions and has a total scoring range of 7-24 in which a lower score indicates a worse outcome.	3, 6 and 12 months
Secondary	Depression	Change in mental health using the Hospital anxiety and depression scale (HADS). This survey consists of two subscales with seven questions each. The score range is 0-21 for each subscale in which a higher score indicates a worse outcome.; Coping inventory for stressful situations (CISS-21); Trauma screening questionnaire (TSQ); Happiness Index (HI); Cognitive functioning questionnaire (CFQ-25)	3, 6 and 12 months
Secondary	Coping with stressful situations	Identification of coping style using the Coping inventory for stressful situations (CISS-21). This survey consists of three subscales with 7 questions each. The score range is 7-30 for each subscale. The subscale with the highest score is indicated as the most prominent coping style at that moment.	3, 6 and 12 months
Secondary	Trauma	Change in trauma symptoms using the trauma screening questionnaire (TSQ). This survey consists of 10 questions with a total score range of 0-10 in which a higher score indicates a worse outcome.	3, 6 and 12 months
Secondary	Subjective Happiness	Subjective happiness is assessed using the Happiness Index (HI). This questionnaire consists of one question with a score range of 0-10. A lower score indicates a worse outcome.	3, 6 and 12 months
Secondary	Cognitive functioning	Change in cognitive functioning is evaluated using the Cognitive failure questionnaire (CFQ-25). This survey consists of 25 questions with a total score range of 25-125. A higher score indicates a worse outcome.	3, 6 and 12 months
Secondary	Changes in dietary and exercise pattern	Dietary and exercise patterns are assessed using a 24-hour diet and exercise recall interview. The participant is asked to recall all food intake and exercise of the day before. The interviewer makes a written report of the details and compares the intake and exercise to reference values.	1,5, 4,5 and 9 months