The Impact of High Versus Standard Enteral Protein Provision on Functional Recovery Following Intensive Care Admission: a Randomized Controlled, Multicenter, Parallel Group Trial in Mechanically Ventilated, Critically Ill Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Critical Illness
- Sponsor
- Maastricht University Medical Center
- Enrollment
- 935
- Locations
- 10
- Primary Endpoint
- Health Related Quality of Life (HRQL)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Health Related Quality of Life (HRQL)
Time Frame: 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 Outcomes
- Mental health status - anxiety/depression(Day 30, 90 and 180 after ICU admission)
- Overall survival(Day 30, 90 and 180 after ICU admission)
- Physical function - 6-minute walk test(Day 30, 90 and 180 after ICU admission)
- Self-reported health(Day 0, Day 30, 90 and 180 after index ICU admission)
- Muscle and nerve function - MRC-sum score(Day 30, 90 and 180 after ICU admission)
- Muscle and nerve function - handgrip strength(Day 30, 90 and 180 after ICU admission.)
- Health-related Quality of Life - SF-36(Day 30, 90 and 180 after ICU admission)
- Mental health status - post-traumatic stress(Day 30, 90 and 180 after ICU admission.)
- Pain intensity(Day 0, Day 30, 90 and 180 after index ICU admission)