PRotEin Provision in Critical IllneSs -2 (PRECISe-2)

April 20, 2026 updated by: Ziekenhuis Oost-Limburg

The Impact of Low Versus Standard Enteral Protein Provision on Health-related Quality of Life Following Intensive Care Admission: a Randomised Controlled, Multicentre, Parallel Group Trial in Mechanically Ventilated, Critically Ill Patients

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1026

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Previous inclusion in the PRECISe-2 trial
  • Transfer from another ICU with an ICU stay longer than 3 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low protein enteral feeding formula
Other: enteral nutrition
0.6 g protein/kg per day during the first 10 days of enteral nutrition and thereafter 0.8 g protein/kg per day
Other: enteral nutrition
1.3 g protein/kg per day during the entire treatment duration
Active Comparator: Standard protein enteral feeding formula
Other: enteral nutrition
0.6 g protein/kg per day during the first 10 days of enteral nutrition and thereafter 0.8 g protein/kg per day
Other: enteral nutrition
1.3 g protein/kg per day during the entire treatment duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: 30, 60, and 90 days after index ICU admission
30, 60, and 90 days after index ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziekenhuis Oost-Limburg

Collaborators

Federaal Kenniscentrum voor Gezondheidszorg, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRECISe-2 (Z-2025138)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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