PRotEin Provision in Critical IllneSs (PRECISe)

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Intensive Care Unit Acquired Weakness; Critical Illness

Treatments: Dietary Supplement: PRECISe protocol EN 8g protein/100kcal; Dietary Supplement: PRECISe protocol EN 5g protein/100kcal

Study type: Interventional

Funder types: Other

Identifiers

NCT04633421

NL73247.068.20

80-85200-98-18574 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 935 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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935 participants in 2 patient groups

PRECISe protocol EN (8g protein/100kcal)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: PRECISe protocol EN 8g protein/100kcal

PRECISe protocol EN (5g protein/100kcal)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: PRECISe protocol EN 5g protein/100kcal