PRotEin Provision in Critical IllneSs
- Conditions
- Critical IllnessIntensive Care Unit Acquired Weakness
- Interventions
- Dietary Supplement: PRECISe protocol EN 8g protein/100kcalDietary Supplement: PRECISe protocol EN 5g protein/100kcal
- Registration Number
- NCT04633421
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
Rapid skeletal muscle wasting during critical illness had a detrimental impact on both short and long term outcomes following ICU admission. Increased dietary protein delivery might attenuate skeletal muscle wasting and its subsequent effects on post-ICU function.
The investigators will conduct a 935 patient, randomised controlled, quadruple blinded parallel group trial to determine whether enteral nutrition with increased protein content in mechanically ventilated, critically ill patients is able to improve functional recovery.
- Detailed Description
ICU-acquired weakness (ICU-AW) is frequent among ICU survivors and negatively affects both short and long term outcomes. ICU-AW is the consequence of the body's reserves being depleted during critical illness and results in severe skeletal muscle wasting during the first week of ICU admission.Therefore, measures aimed at preserving muscle mass during critical illness and improving recovery after ICU discharge are urgently needed.
Retrospective observational cohort studies suggest that the administration of high protein nutrition is associated with improved survival and outcome. Current ICU guidelines recommend dietary protein delivery at 1.3 g/kg/day (ESPEN), or even up to 2.0 g/kg/day (ASPEN). However, strong prospective clinical evidence on the effectiveness and safety of high enteral protein delivery is lacking and urgently awaited. Therefore, the aim of the present study is to investigate the effect of high versus standard protein provision on the functional recovery of critically ill patients.
The focus on functional, patient-centered outcomes rather than traditional clinical endpoints like mortality is an important aspect and strength of the study. Previous nutritional intervention studies focusing primarily on improving mortality have repeatedly shown no effect. Therefore, it is nowadays increasingly recognized to move primary ICU trial endpoints away from classical outcomes, such as survival or length of stay, towards more functional outcomes, in line with the underlying pathophysiology.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 935
- Adult (18 years or above) patient admitted to the ICU
- Unplanned ICU admission
- Invasive mechanical ventilation initiated <24 hours of ICU admission
- Expected ICU stay on ventilator support of 3 days or more
- Contraindication for enteral nutrition
- Moribund or expected withholding of treatment
- Kidney failure AND 'no-dialysis'-code on admission
- Hepatic encephalopathy.(West Haven grade 3 or 4)
- Body-mass index < 18 kg/m2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PRECISe protocol EN (8g protein/100kcal) PRECISe protocol EN 8g protein/100kcal Enteral (EN) feed with 8 grams protein per 100 kcal (2.0 g/kg/day protein when on target). The caloric goal is 25 kcal/kg/day to be reached on day 4 of ICU admission. PRECISe protocol EN (5g protein/100kcal) PRECISe protocol EN 5g protein/100kcal Enteral (EN) feed with 5 grams protein per 100 kcal (1.3 g/kg/day protein when on target). The caloric goal is 25 kcal/kg/day to be reached on day 4 of ICU admission.
- Primary Outcome Measures
Name Time Method Health Related Quality of Life (HRQL) Day 0, Day 30, 90 and 180 after index ICU admission. Overall difference in EQ-5D single summary index between intervention and control group over the three time-points combined, corrected for baseline. A higher summary index indicates better Health related Quality of Life.
- Secondary Outcome Measures
Name Time Method Mental health status - anxiety/depression Day 30, 90 and 180 after ICU admission Hospital Anxiety and Depression Scale (HADS), ranging from 0 to 42. Questions 1, 3, 5, 7, 9, 11 and 13 measure symptoms of anxiety (range: 0-21). Questions 2, 4, 6, 8, 10, 12 and 14 measure symptoms of depression (range: 0-21). Higher scores indicate worse symptoms of anxiety and depression.
Overall survival Day 30, 90 and 180 after ICU admission Overall survival
Physical function - 6-minute walk test Day 30, 90 and 180 after ICU admission 6-minute walk test. Data collected during 6-minute walk test are pre- and post-test saturation and pulse and total distance walked with or without the use of any aids.
Self-reported health Day 0, Day 30, 90 and 180 after index ICU admission EQ-5D Visual Analogue Scale (EQ-VAS), ranging from 0 to 100. A higher score indicates a better self-reported health.
Muscle and nerve function - MRC-sum score Day 30, 90 and 180 after ICU admission Medical Research Council (MRC-)sum score, ranging from 0 to 60. A higher score indicates better muscle and nerve function.
Muscle and nerve function - handgrip strength Day 30, 90 and 180 after ICU admission. Handgrip strength, assessed via a hand dynamometer and measured in kilograms (kg).
Health-related Quality of Life - SF-36 Day 30, 90 and 180 after ICU admission Short Form 36 (SF-36), ranging from 0 to 100. A higher score indicates a better Health-related Quality of Life.
Mental health status - post-traumatic stress Day 30, 90 and 180 after ICU admission. Impact of Event Scale Revised (IES-R), ranging from 0 to 88. A higher score indicates worse symptoms of Post-Traumatic Stress Disorder.
Pain intensity Day 0, Day 30, 90 and 180 after index ICU admission EQ-5D pain question, ranging from 1 to 5, corrected for baseline. A higher score indicates a more severe perception of pain.
Trial Locations
- Locations (10)
UZ Brussel
🇧🇪Brussel, Belgium
CHU Liège
🇧🇪Liège, Belgium
Maastricht Universtair Medisch Centrum
🇳🇱Maastricht, Netherlands
CHR de la Citadelle
🇧🇪Liège, Belgium
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium
AZ Groeninge
🇧🇪Kortrijk, Belgium
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Catharina Ziekenhuis Eindhoven
🇳🇱Eindhoven, Noord-Brabant, Netherlands
Gelderse Vallei Ede
🇳🇱Ede, Netherlands
Zuyderland Medisch Centrum
🇳🇱Heerlen, Netherlands