To investigate whether increased protein provision in critically ill patients during Intensive Care Unit (ICU) admission can improve functional outcome and recovery following ICU discharge
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Critical illness (aandoening die IC opname nodig maakt)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Overall between group-differences in health Related Quality of Life (HRQL) at
30 days, 90 days and 180 days after index ICU admission, assessed by EuroQoL
(EQ-5D-5L).
Secondary outcome
Established Core Outcome Measures Set developed by an international expert
panel using Delphi consensus methods:
• Overall survival
• Changes in health-related quality of life, as assessed by Short Form 36
(SF-36) questionnaire, completed at 30 days, 90 days and 180 days after ICU
admission
• Changes in the mental health status, assessed by the Hospital Anxiety and
Depression Scale (HADS) EQ-VAS of the EQ-5D-5L and IES-R Impact of Event Scale,
all completed at 30 days, 90 days and 180 days after ICU admission
• Changes in the pain level, assessed by the pain question of the EQ-5D-5L
questionnaire, completed at 30 days, 90 days and 180 days after ICU admission
• Changes in physical function, as assessed by the 6-minute walk test performed
at 30 days, 90 days and 180 days after ICU admission
• Changes in muscle and nerve function, as assessed by the MRC-SUM score and
Handgrip strength (Dynamometer), performed at 30 days, 90 days and 180 days
after ICU admission
Background summary
Critical illness is characterised by a catabolic state with increased muscle
protein breakdown, resulting in severe skeletal muscle wasting during ICU stay.
Increased dietary protein might attenuate muscle protein catabolism and it's
subsequent impact on muscle mass and function, therefore enhancing post-ICU
(functional) recovery.
Study objective
To investigate whether increased protein provision in critically ill patients
during Intensive Care Unit (ICU) admission can improve functional outcome and
recovery following ICU discharge
Study design
The PRECISe trial is a pragmatic, international multi-center, randomized
controlled, triple-blinded study in adult, mechanically ventilated patients,
admitted to an Intensive Care Unit.
The study consists of 3 phases:
* Screening phase: starting from identifying a study subject until the first
nutrition will be given.
* Treatment phase: starting from the first nutrition until ICU discharge or a
maximum of 90 days of ICU admission.
* Follow-up phase: starting when the treatment phase ends until 180 (± 4) days
after ICU admission.
Intervention
comparing two isocaloric, isovolumetric enteral feeds with either
- a standard (5g protein/100 kcal) or
- a high (8g protein/100 kcal) protein content
Study burden and risks
For this study, mechanically ventilated patients admitted to the ICU will be
studied. This is a vulnerable patient group that, due to the nature of their
condition, will not able to give informed consent before start of the study.
However, alternative models or patients are not able to answer our research
question, as it is specific for this patient group, making it necessary to
perform this study in a vulnerable population. Critical illness (for which
mechanical ventilator support is necessary for an undetermined period) is a
severe, life-threatening disease with unique and detrimental metabolic
derangement resulting in a spectacularly rapid loss of muscle mass and strength
unlike any other disease state. Therefore, previous work on the effectiveness
of protein provision on function recovery in healthy or less severe disease
conditions cannot simply be extrapolated to ICU patients. However, the
increased protein catabolism and impaired anabolic response during ICU
admission has a severe impact on the recovery and functional outcome in
critically ill patients, both in the short and long-term.
The PRECISe study aims to investigate whether the enteral protein
administration is able to improve functional recovery following ICU admission.
If the study is able to show a benefit of one treatment arm over the other, the
results will be implemented in daily practice where they will lead to better
treatment of critically ill patients. Therefore, this study has the potential
to improve care for this patient population and therefore outweighs the
objection that it requires the study to be performed in a study population
unable to give informed consent by themselves.
No additional risks are involved in the study. The study compares nutritional
strategies that are currently used in daily ICU practice and both strategies
have proven to be safe, well tolerated and without any additional side effects.
P. Debyelaan 25 25
Maastricht 6229 HX
NL
P. Debyelaan 25 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
* Adult (>= 18 years) patient admitted to the ICU
* Unplanned ICU admission
* Invasive mechanical ventilation initiated <24 hours following ICU admission
* Expected ICU stay on mechanical ventilation of >= 3 days
Exclusion criteria
* Contraindication for enteral nutrition at the discretion of the treating
physician
* Moribund or expected withholding of treatment
* Kidney failure and *no dialysis*-code on admission
* Hepatic encephalopathy (West Haven criteria 3-4)
* Body mass index <18 kg/m²
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT04633421 |
| CCMO | NL73247.068.20 |