Skip to main content
OpenTrials
Completed

NCT Number: NCT04154995

Intensive Care Unit Recovery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post Intensive Care Unit Syndrome Critical Illness Disease Attributes Intensive Care Unit Acquired Weakness Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Center Leeuwarden

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Expected length of stay ICU ≥ 48 hours

Exclusion criteria

  • Not applicable

Treatment and study plan

Venipuncture

Diagnostic Test

Blood testing at 3, 6 and 12 months

Ultrasound Quadriceps Muscles

Diagnostic Test

Ultrasound measurement of quadriceps muscle mass and health

Primary outcomes

  1. 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

  1. Quadriceps muscle layer thickness

    Time frame: Baseline, 3, 6 and 12 months

    Quadriceps ultrasound thickness measured in mm. Values below reference values indicate a worse outcome.

  2. Bioimpedance measurement in BIVA

    Time frame: Baseline, 3, 6 and 12 months

    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.

  3. Hand grip strength

    Time frame: Baseline, 3, 6 and 12 months

    Hand grip strength test of the left and right hand in kg. Values below reference values indicate a worse outcome.

  4. Walking distance

    Time frame: 3, 6 and 12 months

    6-minute walk test measures are taken in meters. Values below reference values indicate a worse outcome.

  5. physical activity

    Time frame: Baseline, 3, 6 and 12 months

    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.

  6. Blood c-reactive protein concentration

    Time frame: Baseline, 3, 6 and 12 months

    C-reactive protein (baseline from standard care clinical data) levels from blood samples in mg/L. Higher values indicate a worse outcome.

  7. Blood creatinine concentration

    Time frame: Baseline, 3, 6 and 12 months

    Creatinine (baseline from standard care clinical data) levels from blood samples in μmol/L. Values below or above reference values indicate a worse outcome.

  8. Blood haemoglobin concentration

    Time frame: Baseline, 3, 6 and 12 months

    Haemoglobin (baseline from standard care clinical data) levels from blood samples in mmol/L. Values below or above reference values indicate a worse outcome.

  9. Blood albumin concentration

    Time frame: Baseline, 3, 6 and 12 months

    Albumin (baseline from standard care clinical data) levels from blood samples in g/L. Values below or above reference values indicate a worse outcome.

  10. Blood glucose concentration

    Time frame: Baseline, 3, 6 and 12 months

    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.

  11. Blood glutamine concentration

    Time frame: Baseline, 3, 6 and 12 months

    Glutamine levels from blood samples in mmol/l. Values below reference values indicate a worse outcome.

  12. Biomarkers for mitochondrial dysfunction

    Time frame: Baseline, 3, 6 and 12 months

    Levels of biomarkers for mitochondrial dysfunction from blood samples.

  13. Fatigue

    Time frame: 3, 6 and 12 months

    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.

  14. Depression

    Time frame: 3, 6 and 12 months

    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)

  15. Coping with stressful situations

    Time frame: 3, 6 and 12 months

    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.

  16. Trauma

    Time frame: 3, 6 and 12 months

    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.

  17. Subjective Happiness

    Time frame: 3, 6 and 12 months

    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.

  18. Cognitive functioning

    Time frame: 3, 6 and 12 months

    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.

  19. Changes in dietary and exercise pattern

    Time frame: 1,5, 4,5 and 9 months

    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.

Other outcomes

  1. Baseline demographic data

    Time frame: Baseline, 3, 6 and 12 months

    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).

  2. Clinical data during ICU stay from standard care

    Time frame: Retrieved at 12 months from electronic patient data file

    Standard care ICU-characteristics

Sponsors and collaborators

Lead sponsor

Frisius Medisch Centrum

Other

Registry information

Official study title

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

Acronym: ICU-RE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 7, 2019
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.