PRotEin Provision in Critical IllneSs

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

Sponsors

Lead Sponsor: Maastricht University Medical Center

Collaborator: Ziekenhuis Oost-Limburg
Zuyderland Medisch Centrum
Gelderse Vallei Hospital
Medisch Spectrum Twente
Centre Hospitalier Universitaire Liège
Centre Hospitalier Régional de la Citadelle
Universitair Ziekenhuis Brussel
General Hospital Groeninge

Source 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 824 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.

Overall Status Recruiting
Start Date 2020-11-19
Completion Date 2023-05-01
Primary Completion Date 2023-05-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Health Related Quality of Life (HRQL) Day 0, Day 30, 90 and 180 after index ICU admission.
Secondary Outcome
Measure Time Frame
Overall survival 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 - anxiety/depression Day 30, 90 and 180 after ICU admission
Pain intensity Day 0, Day 30, 90 and 180 after index ICU admission
Self-reported health Day 0, Day 30, 90 and 180 after index ICU admission
Mental health status - post-traumatic stress Day 30, 90 and 180 after ICU admission.
Physical function - 6-minute walk test Day 30, 90 and 180 after 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.
Enrollment 824
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: PRECISe protocol EN 8g protein/100kcal

Description: Enteral feed containing 8g protein/100kcal

Arm Group Label: PRECISe protocol EN (8g protein/100kcal)

Intervention Type: Dietary Supplement

Intervention Name: PRECISe protocol EN 5g protein/100kcal

Description: Enteral feed containing 5g protein/100kcal

Arm Group Label: PRECISe protocol EN (5g protein/100kcal)

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Marcel CG van de Poll, MD, PhD Principal Investigator Maastricht UMC+
Overall Contact

Last Name: Julia LM Bels, MD

Phone: 06 30480685

Phone Ext.: +31

Email: [email protected]

Location
Facility: Status: Contact:
UZ Brussel | Brussel, Belgium Recruiting Elisabeth de Waele, MD, PhD
Ziekenhuis Oost-Limburg | Genk, 3600, Belgium Recruiting Dieter Mesotten [email protected]
AZ Groeninge | Kortrijk, Belgium Recruiting Stoffel Lamote, MD, PhD
CHR de la Citadelle | Liège, Belgium Recruiting Vincent Fraipont, MD, PhD
CHU Liège | Liège, Belgium Recruiting Didier Ledoux, MD, PhD
Gelderse Vallei Ede | Ede, Netherlands Recruiting Arthur van Zanten, MD, PhD
Medisch Spectrum Twente | Enschede, Netherlands Recruiting Bert Beishuizen, MD, PhD
Zuyderland Medisch Centrum | Heerlen, Netherlands Recruiting Clarissa Scheeren, MD
Maastricht Universtair Medisch Centrum | Maastricht, Netherlands Recruiting Marcel van de Poll, MD, PhD
Location Countries

Belgium

Netherlands

Verification Date

2021-03-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: PRECISe protocol EN (8g protein/100kcal)

Type: Experimental

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.

Label: PRECISe protocol EN (5g protein/100kcal)

Type: Active Comparator

Description: Enteral (EN) feed with 5 grams protein per 100 kcal (1.2 g/kg/day protein when on target). The caloric goal is 25 kcal/kg/day to be reached on day 4 of ICU admission.

Acronym PRECISe
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: Study feeds will be blinded. Dosing of intervention will be volume based, with the same volume targets for both groups. Differences in composition of study feeds will result in differences in protein intake at similar volume administration.

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