PRotEin Provision in Critical IllneSs -2

NCT07529522 | Not Yet Recruiting DMC

• 1 other identifier: PRECISe-2 (Z-2025138)
• Study Type: interventional
• Target: 1,026
• Locations: 2 countries
• Sites: 15

Brief Summary

When patients survive a life-threatening condition in the intensive care unit (ICU), they often face a prolonged recovery process marked by persistent health issues that significantly reduce their quality of life. Muscle weakness is the most defining feature of this post-intensive care syndrome. This weakness, along with the associated decline in quality of life, presents major challenges for patients, their families, and the healthcare system, including the high costs of long-term care. Until recently, it was believed that providing additional nutrition-particularly protein-during the early phase of a critical illness could help prevent muscle loss and promote recovery. However, the recent PRECISe study showed that administering a high amount of protein (target: 2 g/kg per day) via feeding tube actually worsened outcomes: patients who received high-protein nutrition during the acute phase reported a lower quality of life over the six months following ICU admission and were discharged from the hospital later. These findings from the PRECISe study have renewed attention on the amount of protein administered to critically ill patients. Current European ICU nutrition guidelines (1.3 g/kg per day) recommend a higher protein intake than the daily recommended amount for healthy individuals (0.8 g/kg per day). However, in critically ill patients, protein metabolism may be impaired, potentially leading to the accumulation of toxic protein breakdown products and hindering recovery, ultimately resulting in a lower quality of life. Reducing protein intake below the level recommended for healthy individuals during the acute phase of a life-threatening illness-while maintaining total energy intake (calories)-may be beneficial for long-term recovery and rehabilitation. The PRECISe-2 study investigates whether patients who receive less protein (0.6-0.8 g/kg per day) but sufficient energy during the early phase of their critical illness feel better and experience a higher quality of life in the long term compared to those who receive the standard amount of protein (1.3 g/kg per day).

Conditions

Critical Illness; Intensive Care (ICU)

Outcome Measures

Primary Outcomes (1)

• Overall longitudinal between group difference in Health-Related Quality of Life (HRQL) at 30, 60, and 90 days after index ICU admission assessed by EuroQoL (EQ-5D-5L)

  30, 60, and 90 days after index ICU admission

Study Arms (2)

Low protein enteral feeding formula

EXPERIMENTAL

Other: enteral nutrition

Standard protein enteral feeding formula

ACTIVE COMPARATOR

Other: enteral nutrition

Interventions

enteral nutrition OTHER

0.6 g protein/kg per day during the first 10 days of enteral nutrition and thereafter 0.8 g protein/kg per day

Low protein enteral feeding formula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥ 18 years-old) patient
• Admission to the ICU
• Invasive, mechanical ventilation initiated within 72 hours following ICU admission, or mechanically ventilated upon arrival to the ICU
• Expected ICU stay on mechanical ventilation of ≥ 3 days after randomisation

You may not qualify if:

• Expected contra-indication for enteral nutrition for at least one week, at the discretion of the treating physician, such as a bowel discontinuity that cannot be solved within one week
• Moribund (expected to die within 48 hours) or withholding of treatment (DNR code 3)
• Transfer from another ICU with an ICU stay longer than 3 days

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead
• Federaal Kenniscentrum voor Gezondheidszorg, Belgium: collaborator

Study Sites (15)

UZ Antwerpen

Antwerp, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

AZ Maria Middelares

Ghent, Belgium

Location

UZ Gent

Ghent, Belgium

Location

Jessa Ziekenhuis

Hasselt, Belgium

Location

UZ Brussel

Jette, Belgium

Location

AZ Groeninge

Kortrijk, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

CHC MontLégia

Liège, Belgium

Location

CHR de la Citadelle

Liège, Belgium

Location

CHU Liège

Liège, Belgium

Location

Clinique St. Pierre

Ottignies-Louvain-la-Neuve, Belgium

Location

AZ Delta

Roeselare, Belgium

Location

MUMC+

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (14); NL (1)