Clinical trial NCT04154995: Intensive Care Unit Recovery
Official title: Long-term Recovery of Patients Admitted to the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Intensive Care Unit Syndrome
Intensive Care Unit Acquired Weakness
Critical Illness
Keywords: Long-term recovery
Critical Illness
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* Expected length of stay ICU ≥ 48 hours

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Health-related Quality of Life
timeFrame: Baseline, 3, 6 and 12 months
Secondary outcomes:
measure: Quadriceps muscle layer thickness
timeFrame: Baseline, 3, 6 and 12 months
measure: Bioimpedance measurement in BIVA
timeFrame: Baseline, 3, 6 and 12 months
measure: Hand grip strength
timeFrame: Baseline, 3, 6 and 12 months
measure: Walking distance
timeFrame: 3, 6 and 12 months
measure: physical activity
timeFrame: Baseline, 3, 6 and 12 months
measure: Blood c-reactive protein concentration
timeFrame: Baseline, 3, 6 and 12 months
measure: Blood creatinine concentration
timeFrame: Baseline, 3, 6 and 12 months
measure: Blood haemoglobin concentration
timeFrame: Baseline, 3, 6 and 12 months
measure: Blood albumin concentration
timeFrame: Baseline, 3, 6 and 12 months
measure: Blood glucose concentration
timeFrame: Baseline, 3, 6 and 12 months
measure: Blood glutamine concentration
timeFrame: Baseline, 3, 6 and 12 months
measure: Biomarkers for mitochondrial dysfunction
timeFrame: Baseline, 3, 6 and 12 months
measure: Fatigue
timeFrame: 3, 6 and 12 months
measure: Depression
timeFrame: 3, 6 and 12 months
measure: Coping with stressful situations
timeFrame: 3, 6 and 12 months
measure: Trauma
timeFrame: 3, 6 and 12 months
measure: Subjective Happiness
timeFrame: 3, 6 and 12 months
measure: Cognitive functioning
timeFrame: 3, 6 and 12 months
measure: Changes in dietary and exercise pattern
timeFrame: 1,5, 4,5 and 9 months
Other outcomes:
measure: Baseline demographic data
timeFrame: Baseline, 3, 6 and 12 months
measure: Clinical data during ICU stay from standard care
timeFrame: Retrieved at 12 months from electronic patient data file
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
state: Friesland
Study officials:
References: