PRotEin Provision in Critical IllneSs

Maastricht University Medical Center935 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Critical Illness Intensive Care Unit Acquired Weakness

Interventions

PRECISe protocol EN 8g protein/100kcalDIETARY_SUPPLEMENT

Enteral feed containing 8g protein/100kcal

PRECISe protocol EN 5g protein/100kcalDIETARY_SUPPLEMENT

Enteral feed containing 5g protein/100kcal

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

UZ Brussel

Brussels, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

AZ Groeninge

Kortrijk, Belgium

CHR de la Citadelle

Liège, Belgium

Outcomes

Primary Outcomes

Health Related Quality of Life (HRQL)

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.

Time frame: Day 0, Day 30, 90 and 180 after index ICU admission.

Secondary Outcomes

Overall survival

Time frame: Day 30, 90 and 180 after ICU admission

Health-related Quality of Life - SF-36

Short Form 36 (SF-36), ranging from 0 to 100. A higher score indicates a better Health-related Quality of Life.

Time frame: Day 30, 90 and 180 after ICU admission

Mental health status - anxiety/depression

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.

Time frame: Day 30, 90 and 180 after ICU admission

Pain intensity

EQ-5D pain question, ranging from 1 to 5, corrected for baseline. A higher score indicates a more severe perception of pain.

Time frame: Day 0, Day 30, 90 and 180 after index ICU admission

Self-reported health

EQ-5D Visual Analogue Scale (EQ-VAS), ranging from 0 to 100. A higher score indicates a better self-reported health.

Time frame: Day 0, Day 30, 90 and 180 after index ICU admission

Mental health status - post-traumatic stress

Data from ClinicalTrials.gov

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