The main objective of the study is to explore the potential associations between metabolic signatures (hypercatabolism, muscle metabolism, nutritional status, inflammatory response, and gut health) during the acute phase of critical illness and PICS…
ID
Source
Brief title
Synonym
Health condition
Post-Intensive Care Syndroom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is physical functioning at 3-months post-ICU admission,
assessed by multiple outcomes including the physical component score of the
Short Form-36 questionnaire, handgrip strength, 30-second chair stand test, m.
rectus femoris cross-sectional area, quadriceps muscle layer thickness, calf
circumference, and body composition.
Secondary outcome
Secondary study parameters entail hypercatabolism, muscle metabolism,
nutritional status, inflammation, gut health, cognitive function, mental health
status, sleep quality, health-related quality of life, and dietary intake.
These parameters will be assessed by the means of questionnaires, blood
analyses and/or fecal analyses. Besides, ICU admission characteristics and
clinical parameters throughout ICU stay will be recorded.
Background summary
Yearly, more than 70.000 patients are admitted to the intensive care unit (ICU)
in the Netherlands. Although survival rates from critical illness have improved
over the last decades, still patients suffer from long-term physical, cognitive
and mental health impairments, known as post-intensive care syndrome (PICS).
Studies investigating strategies to improve recovery after critical illness
have shown limited effectiveness. This might be due to heterogeneous recovery
trajectories observed among ICU survivors. Research has focussed on the
associations between non-modifiable factors (e.g., age, sex and body-mass
index) and PICS outcomes. However, comprehensive assessment of metabolic
signatures during critical illness (such as hypercatabolism, muscle metabolism,
nutritional status, inflammatory response, and gut health) is lacking. These
modifiable factors might be of interest as these likely shape the recovery
trajectory of critical illness survivors. This approach, by combining the
assessment of nonmodifiable factors together with potentially modifiable
factors, is essential for understanding the complex, multifactorial,
pathophysiological mechanisms underlying PICS.
Study objective
The main objective of the study is to explore the potential associations
between metabolic signatures (hypercatabolism, muscle metabolism, nutritional
status, inflammatory response, and gut health) during the acute phase of
critical illness and PICS outcomes in the recovery trajectory of ICU survivors,
with a primary focus on physical functioning. Besides, this study explores the
trajectory of metabolic parameters from the acute phase of critical illness
throughout recovery 12 months after ICU admission, and whether the metabolic
signatures are useful to distinguish different physical recovery patterns.
Study design
The study is a monocentre, longitudinal, explorative, prospective,
observational study. Study measurements will be performed upon ICU admission,
and in the recovery period (ICU discharge, 3-, 6-, and 12-months post-ICU
admission).
Study burden and risks
ICU admission characteristics and clinical parameters throughout ICU stay will
be recorded as part of standard care and collected from medical records
retrospectively. There is no direct benefit for the patients except for their
contribution to the scientific knowledge of modifiable factors related to
long-term critical illness recovery. The main burden associated with
participation in the study is time investment for the study procedures
performed during the recovery phase (approximately 3 hours per timepoint, and
for total study participation 12 hours); assessment of physical functioning,
completion of questionnaires, blood and faecal collection, and assessment of
dietary intake.
During ICU admission and ICU discharge, an additional amount of blood and a
faecal sample are collected as part of standard clinical care, by using an
arterial or venous line in situ for treatment purposes, and by using different
faecal collection methods depending on the clinical situation of the patient,
respectively. These extra blood samples and the collected faecal samples will
be stored for research purposes. Blood samples are collected to assess
parameters for hypercatabolism, muscle metabolism, nutritional status,
inflammation and gut health, and faecal samples are collected for intestinal
inflammation, short-chain fatty acids, and gut microbiome analysis at different
timepoints. A phlebotomist will collect blood samples via venipuncture at 3-
and 12-months post-ICU admission, which may cause slight discomfort. The
collection of faecal samples during the visits at 3- and 12-months post-ICU
admission by the patients themselves is a potential burden for the patient.
Risks associated with participation are confined to the normal risks of taking
a blood sample (risks of fainting and/or bruising). No risks have been expected
for undergoing body composition assessment or muscle ultrasound.
Willy Brandtlaan 10
Ede 6716RP
NL
Willy Brandtlaan 10
Ede 6716RP
NL
Listed location countries
Age
Inclusion criteria
1. Age >=18 years at time of ICU admission;
2. Received IMV within 48 hours after ICU admission;
3. Expected IMV duration of >=48 hours during ICU stay.
Exclusion criteria
1. Concurrent participation in an intervention study with an anticipated
therapeutic effect on PICS outcomes (physical functioning, cognitive
functioning, or mental health status);
2. Pre-admission diagnosis of a progressive neurological disease (e.g.,
Alzheimer*s disease, Parkinson*s disease, amyotrophic lateral sclerosis,
progressive forms of multiple sclerosis);
3. Participants with neurological paralysis significantly affecting leg
function (e.g., spinal cord injury, multiple sclerosis).
4. Patients receiving palliative care, with a life expectancy of <3 months
(e.g., hospice care or equivalent);
5. Patients who are moribund (i.e., in the final stages of a terminal illness,
with imminent death expected);
6. Anticipated logistical limitations during recovery phase (e.g., transfer to
another hospital, no fixed abode).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87540.091.24 |