Critical IllnessPRECISe-2NCT07529522
PRotEin Provision in Critical IllneSs -2
A study testing enteral nutrition in people with Critical Illness and Intensive Care (ICU), run by Ziekenhuis Oost-Limburg at 15 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Intensive Care (ICU)
- What is being tested?
- enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,026 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Sep 2026to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 2 countries
Belgium14 sites
UZ Antwerpen
Antwerp
Petra Vertongen, +32 (0)3 821 44 04, Studies.INZO@uza.be
Ziekenhuis Oost-Limburg
Genk
Ingrid Meex, +32 (0)89 32 52 07, ingrid.meex@zol.be
AZ Maria Middelares
Ghent
Annelies Van Damme, +32 (0)9 246 17 02, Annelies.VanDamme@mijnziekenhuis.be
UZ Gent
Ghent
Daisy Vermeiren, +32 (0)9 332 05 08, Daisy.vermeiren@uzgent.be
Jessa Ziekenhuis
Hasselt
Laurien Geebelen, +32 (0)11 33 98 85, Laurien.geebelen@jesszh.be
UZ Brussel
Jette
Merel Stevens, +32 (0)2 476 30 96, Merel.stevens@uzbrussel.be
AZ Groeninge
Kortrijk
Sofie Lagast, +32 (0)56 63 30 97, Sofie.lagast@azgroeninge.be
UZ Leuven
Leuven
Liese Mebis, +32 (0)16 34 40 21, liese.mebis@uzleuven.be
UZ Leuven
Leuven
Shannon Nicolai, +32 (0)16 34 09 11, Studies.ial@uzleuven.be
CHC MontLégia
Liège
Leonie Deugoué, MD, +32 (0)498 28 64 30, deugoue.leonie@gmail.com
CHR de la Citadelle
Liège
Maxime Samalea Suarez, +32 (0)4 321 51 06, Maxime.SamaleaSuarez@citadelle.be
CHU Liège
Liège
Gwaëlle Ducomble, +32 (0)4 323 27 08, Gwaelle.Ducomble@chuliege.be
Clinique St. Pierre
Ottignies-Louvain-la-Neuve
Anne Thirifays, +32 (0)10 43 75 56, Anne.thirifays@cspo.be
AZ Delta
Roeselare
Daphne Decruyenaere, +32 (0)51 23 76 83, daphne.decruyenaere@azdelta.be
Netherlands1 site
MUMC+
Maastricht
Marcel van de Poll, +31 (0)6 508 669 17, marcel.vande.poll@mumc.nl
About this study
Official title: 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.
Read more
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)
- Being tested
- enteral nutrition
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral nutritionOther
0.6 g protein/kg per day during the first 10 days of enteral nutrition and thereafter 0.8 g protein/kg per day
enteral nutritionOther
1.3 g protein/kg per day during the entire treatment duration
| Study group | Role | What they receive |
|---|---|---|
| Low protein enteral feeding formula | Experimental | Not described Receives: Other: enteral nutrition |
| Standard protein enteral feeding formula | Active comparator | Not described Receives: Other: enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall longitudinal between group-difference in Health-Related Quality of Life (HRQL) at 30, 60, and 90 days after index ICU admission corrected for the pre-admission EQ-5D-5L summary index, assessed by EuroQoL (EQ-5D-5L)
Measured: 30, 60, and 90 days after index ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,026 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Collaborators
- Federaal Kenniscentrum voor Gezondheidszorg, Belgium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529522
- Sponsor's protocol ID
- PRECISe-2 (Z-2025138)
- Acronym
- PRECISe-2
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07529522
- Acronym / sponsor ID
- PRECISe-2 / PRECISe-2 (Z-2025138)
- Conditions
- Critical Illness, Intensive Care (ICU)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,026 participants (estimated)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Collaborators
- Federaal Kenniscentrum voor Gezondheidszorg, Belgium
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low protein enteral feeding formula | Experimental | Other: enteral nutrition |
| Standard protein enteral feeding formula | Active comparator | Other: enteral nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enteral nutrition0.6 g protein/kg per day during the first 10 days of enteral nutrition and thereafter 0.8 g protein/kg per day | Other | Low protein enteral feeding formula |
| enteral nutrition1.3 g protein/kg per day during the entire treatment duration | Other | Standard protein enteral feeding formula |
Primary outcome
overall longitudinal between group-difference in Health-Related Quality of Life (HRQL) at 30, 60, and 90 days after index ICU admission corrected for the pre-admission EQ-5D-5L summary index, assessed by EuroQoL (EQ-5D-5L)
Time frame: 30, 60, and 90 days after index ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enteral nutrition in people with Critical Illness and Intensive Care (ICU), run by Ziekenhuis Oost-Limburg at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall longitudinal between group-difference in Health-Related Quality of Life (HRQL) at 30, 60, and 90 days after index ICU admission corrected for the pre-admission EQ-5D-5L summary index, assessed by EuroQoL (EQ-5D-5L) (time frame: 30, 60, and 90 days after index ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.