Nutrition is an important part of treatment in the Intensive Care Unit (ICU) because patients consume and need a lot of energy during their admission. The goal of good nutrition is that patients stay as strong as possible and get through their intensive care admission as well as possible. The amount of protein in particular seems to be very important here; the breakdown of muscle protein is an important reason why patients become very weak during an Intensive Care (IC) admission. When participating, patients are randomised between two groups:1. A group receives food with the standard amount of protein2. Another group receives food with a higher amount of protein.The food is used during the intensive care admission.With this research we want to see whether giving more protein than usual to reduce this muscle breakdown can speed up recovery after intensive care admission.Giving food via a feeding probe is standard care in intensive care and both amounts of protein are already applied in daily practice.We just want to view which of the two power supplies is the best. The treatment is therefore no different from the usual care.The follow-up after intensive care is different than usual. Normally, a doctor's check may take place once only once 3-6 months after an IC admission. Now that will be 3 times and recovery to be tested more extensively than usual.
| Summary of results |
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The aim of the PRECISe trial was to assess whether higher enteral protein provision (i.e. 2.0g/kg per day) would improve health-related quality of life and functional outcomes in critically ill patients who were mechanically ventilated compared with standard enteral protein provision (i.e. 1.3g/kg per day). Between November 19, 2020, and April 14, 2023, 935 patients (335 (35.8%) female, 600 (64.2%) male) were randomly assigned to one of two groups: 465 (49.7%) to the standard protein group and 470 (50.3%) to the high protein group. The primary outcome, i.e. the EQ-5D-5L health-related quality of life over the 180 days following randomisation (assessed at 30 days, 90 days, and 180 days), was assessed in 430 (92.5%) of 465 patients in the standard protein group and 419 (89.1%) of 470 patients in the high protein group. This score was lower in patients allocated to the high protein group than in those allocated to the standard protein group, with a mean difference of -0.05 (95% CI -0.10 to -0.01; p=0.031). Regarding safety outcomes, the mortality risk over the entire follow-up was 0.38 (SE 0.02) in the standard protein group and 0.42 (0.02) in the high protein group (hazard ratio 1.14, 95% CI 0.92 to 1.40; p=0.22). There was also a higher incidence of symptoms of gastrointestinal intolerance in patients in the high protein group (odds ratio 1.76, 95% CI 1.06 to 2.92; p=0.030). Incidence of other adverse events did not differ between groups. In conclusion, high enteral protein provision compared with standard enteral protein provision resulted in worse health-related quality of life in critically ill patients and did not improve functional outcomes over the 180 days following ICU randomisation (following ICU admission). |
| Title |
The impact of high versus standard enteral protein provision on functional recovery following Intensive Care admission: a triple blind, randomized controlled, multicentre, parallel group trial in mechanically ventilated, critically ill patients |
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Participants (P) |
Adult, mechanically ventilated patients admitted to the ICU with a clear indication for enteral nutrition (i.e. an expected stay on ventilator of at least 3 days). |
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Intervention (I) |
Enteral nutrition with a high protein (8g protein/100 kcal) and normal energy content (i.e. isocaloric, isovolumetric) |
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Control (C) |
Enteral nutrition containing standard protein (5g protein/100 kcal) and normal energy content (i.e. isocaloric, isovolumetric) |
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Outcome (O) |
The primary objective of the PRECISE study is to assess whether increased enteral protein provision during critical illness improves Health Related Quality of Life after ICU admission. |
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Trial Design |
The PRECISE trial is a pragmatic, international multi-centre, randomized controlled, triple-blind study comparing two isocaloric, isovolumetric enteral feeds with either a standard (5g protein/100 kcal) or high (8g protein/100 kcal) protein content in adult, mechanically ventilated patients admitted to an Intensive Care Unit. |
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Sample Size |
824 patients |
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Trial duration |
27 months |
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Budget |
€1.85M (Bel: €0.91M) |
| Sponsor | International study sponsor : Maastricht Universitair Medisch Centrum Belgian Coordinating Center: Ziekenhuis Oost-Limburg |
| Chief Investigator | Sponsor: Prof. Dr. Van De Poll BCC: Prof. Dr. Dieter Mesotten
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| Sites | NL: 4 centres (MUMC+, Gelderse Vallei Ede, Zuyderland Heerlen, MST Enschede) Bel: 5 centres (ZOL, CHU Liège, VUB, CHR de la Citadelle, Groeninge Kortrijk) |
Clinicaltrials.gov: NCT04633421
Webpage: https://www.preciseclinicaltrial.com
