Intensive Care Unit Recovery (ICU-RE)

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Intensive Care Unit Acquired Weakness; Post Intensive Care Unit Syndrome
• Intervention / Treatment: Diagnostic test: Venipuncture; Diagnostic test: Ultrasound Quadriceps Muscles

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.

• Study Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• Netherlands
  • Friesland
    • Leeuwarden, Friesland, Netherlands, 8934 AD
      • Medical Center Leeuwarden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• Expected length of stay ICU ≥ 48 hours

Exclusion Criteria:

• Not applicable

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Long-term ICU patients; Patients with a ICU length of stay of at least 48 hours.	Diagnostic test: Venipuncture; Blood testing at 3, 6 and 12 months; Diagnostic test: Ultrasound Quadriceps Muscles; Ultrasound measurement of quadriceps muscle mass and health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quadriceps muscle layer thickness	Quadriceps ultrasound thickness measured in mm. Values below reference values indicate a worse outcome.	Baseline, 3, 6 and 12 months
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
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
Walking distance	6-minute walk test measures are taken in meters. Values below reference values indicate a worse outcome.	3, 6 and 12 months
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
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
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
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
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
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
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
Biomarkers for mitochondrial dysfunction	Levels of biomarkers for mitochondrial dysfunction from blood samples.	Baseline, 3, 6 and 12 months
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Clinical data during ICU stay from standard care	Standard care ICU-characteristics	Retrieved at 12 months from electronic patient data file

Collaborators and Investigators

• Sponsor: Medical Centre Leeuwarden

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Critical Illness; Long-term recovery
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: RTPO 1055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No