An interventional study of enteral nutrition and enteral nutrition in Critical Illness and Intensive Care (ICU), sponsored by Ziekenhuis Oost-Limburg. Not yet recruiting at 15 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Ziekenhuis Oost-Limburg · Not applicable, Interventional, and Other
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).
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's planned enrollment of 1,026 is above the median of 90 across 926 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Ziekenhuis Oost-Limburg is the lead sponsor of 69 studies on the registry; 16 are open to participants now.
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Other: enteral nutrition
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
1.3 g protein/kg per day during the entire treatment duration
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jul 2029, 34 months later.
Of 399 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 34 months is above that.
Counting every sponsor, half of 403 studies reached it within 21 months; a quarter within 12 and three quarters within 40.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Ziekenhuis Oost-Limburg