Post Intensive Care Unit SyndromeICU-RENCT04154995
Intensive Care Unit Recovery
An observational study of Post Intensive Care Unit Syndrome and Intensive Care Unit Acquired Weakness, run by Frisius Medisch Centrum at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Intensive Care Unit Syndrome, Intensive Care Unit Acquired Weakness, Critical Illness
- What is being tested?
- Venipuncture and Ultrasound Quadriceps Muscles
- How many people
- 81 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 May 2019to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Expected length of stay ICU ≥ 48 hours
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Medical Center Leeuwarden
Leeuwarden, Provincie Friesland, 8934 AD
About this study
Official title: 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.
Read the 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.
- Conditions
- Post Intensive Care Unit Syndrome, Intensive Care Unit Acquired Weakness, Critical Illness
- Being tested
- Venipuncture, Ultrasound Quadriceps Muscles
- Keywords
- Long-term recovery, Critical Illness
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenipunctureDiagnostic test
Blood testing at 3, 6 and 12 months
Ultrasound Quadriceps MusclesDiagnostic test
Ultrasound measurement of quadriceps muscle mass and health
| Study group | Role | What they receive |
|---|---|---|
| Long-term ICU patients | Patients with a ICU length of stay of at least 48 hours. Receives: Diagnostic Test: Venipuncture; Diagnostic Test: Ultrasound Quadriceps Muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3, 6 and 12 months
Secondary outcomes (19)
Quadriceps muscle layer thickness
Quadriceps ultrasound thickness measured in mm. Values below reference values indicate a worse outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3, 6 and 12 months
Biomarkers for mitochondrial dysfunction
Levels of biomarkers for mitochondrial dysfunction from blood samples.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1,5, 4,5 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start20 May 2019
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E.C. Boerma, Frisius Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154995
- Sponsor's protocol ID
- RTPO 1055
- Acronym
- ICU-RE
- Status last verified
- Jan 2021
- First submitted
- 20 May 2019
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Recovery of Patients Admitted to the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04154995
- Acronym / sponsor ID
- ICU-RE / RTPO 1055
- Conditions
- Post Intensive Care Unit Syndrome, Intensive Care Unit Acquired Weakness, Critical Illness
- Keywords
- Long-term recovery, Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long-term ICU patients | – | Diagnostic Test: Venipuncture, Diagnostic Test: Ultrasound Quadriceps MusclesPatients with a ICU length of stay of at least 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Expected length of stay ICU ≥ 48 hours
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenipunctureBlood testing at 3, 6 and 12 months | Diagnostic test | Long-term ICU patients |
| Ultrasound Quadriceps MusclesUltrasound measurement of quadriceps muscle mass and health | Diagnostic test | Long-term ICU patients |
Primary outcome
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.
19 secondary outcomes
Quadriceps muscle layer thickness
Time frame: Baseline, 3, 6 and 12 months
Bioimpedance measurement in BIVA
Time frame: Baseline, 3, 6 and 12 months
Hand grip strength
Time frame: Baseline, 3, 6 and 12 months
Walking distance
Time frame: 3, 6 and 12 months
physical activity
Time frame: Baseline, 3, 6 and 12 months
Blood c-reactive protein concentration
Time frame: Baseline, 3, 6 and 12 months
Blood creatinine concentration
Time frame: Baseline, 3, 6 and 12 months
Blood haemoglobin concentration
Time frame: Baseline, 3, 6 and 12 months
Blood albumin concentration
Time frame: Baseline, 3, 6 and 12 months
Blood glucose concentration
Time frame: Baseline, 3, 6 and 12 months
Blood glutamine concentration
Time frame: Baseline, 3, 6 and 12 months
Biomarkers for mitochondrial dysfunction
Time frame: Baseline, 3, 6 and 12 months
Fatigue
Time frame: 3, 6 and 12 months
Depression
Time frame: 3, 6 and 12 months
Coping with stressful situations
Time frame: 3, 6 and 12 months
Trauma
Time frame: 3, 6 and 12 months
Subjective Happiness
Time frame: 3, 6 and 12 months
Cognitive functioning
Time frame: 3, 6 and 12 months
Changes in dietary and exercise pattern
Time frame: 1,5, 4,5 and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Intensive Care Unit Syndrome and Intensive Care Unit Acquired Weakness, run by Frisius Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related Quality of Life (time frame: Baseline, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.