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Intensive Care Unit Recovery (ICU-RE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154995
Recruitment Status : Active, not recruiting
First Posted : November 7, 2019
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
E.C. Boerma, Medical Centre Leeuwarden

Tracking Information
First Submitted Date May 20, 2019
First Posted Date November 7, 2019
Last Update Posted Date May 27, 2020
Actual Study Start Date May 20, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 4, 2019)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 27, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: November 4, 2019)
  • 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.
  • Bioimpedance measurements [ 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.
  • 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.
  • 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.
  • Mobility, movement and 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Anxiety and 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)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: February 5, 2020)
  • 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).
  • Clinical data during ICU stay from standard care [ Time Frame: Retrieved at 12 months from electronic patient data file ]
    Standard care ICU-characteristics
Original Other Pre-specified Outcome Measures
 (submitted: November 4, 2019)
  • 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).
  • Clinical data during ICU stay from standard care [ Time Frame: Retrieved at 12 months from electronic patient data file ]
    Length of stay ICU, length of stay hospital, Body Mass Index (kg/m^2) using body length and weight, Acute Physiology, Age, Chronic Health Evaluation (APACHE) IV score, Simplified Acute Physiology Score (SAPS), Sequential Organ Failure Assessment (SOFA) score, medical comorbidities, medication administered, Clinical Frailty Scale score (1-7, in which higher scores indicate a worse outcome), duration and method of mechanical ventilation, moment of first mobilization (date), occurrence of delirium (y/n), Barthel Index Score (0-20, lower score is worse outcome), occurrence of readmission, and mortality (date)
 
Descriptive Information
Brief Title Intensive Care Unit Recovery
Official Title Long-term Recovery of Patients Admitted to the Intensive Care Unit
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 and glutamine concentrations. 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients admitted to the ICU with an expected stay of 48 hours or longer will be asked for consent to participation of this study. The average number of patients admitted per year to the ICU of Medical Centre Leeuwarden with a length of stay (LOS) > 48 hours is 230. Due to practical limitations, we aim to include a maximum number of 80 patients within a six-month period. After six months, the inclusion will be stopped irrespective of the number of included patients.
Condition
  • Post Intensive Care Unit Syndrome
  • Intensive Care Unit Acquired Weakness
  • Critical Illness
Intervention
  • Diagnostic Test: Venipuncture
    Blood testing at 3, 6 and 12 months
  • Diagnostic Test: Ultrasound Quadriceps Muscles
    Ultrasound measurement of quadriceps muscle mass and health
Study Groups/Cohorts Long-term ICU patients
Patients with a ICU length of stay of at least 48 hours.
Interventions:
  • Diagnostic Test: Venipuncture
  • Diagnostic Test: Ultrasound Quadriceps Muscles
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 25, 2020)
81
Original Estimated Enrollment
 (submitted: November 4, 2019)
80
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Expected length of stay ICU ≥ 48 hours

Exclusion Criteria:

  • Not applicable
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT04154995
Other Study ID Numbers RTPO 1055
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party E.C. Boerma, Medical Centre Leeuwarden
Study Sponsor Medical Centre Leeuwarden
Collaborators Not Provided
Investigators Not Provided
PRS Account Medical Centre Leeuwarden
Verification Date May 2020