Evidence map›Paper›PMID 37337234›Full record

ArticleTrials2023

The impact of high versus standard enteral protein provision on functional recovery following intensive care admission (PRECISE trial): study protocol for a randomized controlled, quadruple blinded, multicenter, parallel group trial in mechanically ventilated patients.

Rob J J van Gassel, Julia L M Bels, Katrien Tartaglia, Bas C T van Bussel, Sander M J van Kuijk, Adam M Deane, Zudin Puthucheary, Peter J M Weijs, Lilian Vloet, Bert Beishuizen and 9 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04633421 (The Impact of High Versus Standard Enteral Protein Provision on Functional Recovery Following Intensive Care Admission), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04633421 nacompletednot on this map

The Impact of High Versus Standard Enteral Protein Provision on Functional Recovery Following Intensive Care Admission: a Randomized Controlled, Multicenter, Parallel Group Trial in Mechanically Ventilated, Critically Ill Patients

TypeinterventionalSponsorMaastricht University Medical CenterRan2020 to 2023Enrolled935ConditionsCritical Illness, Intensive Care Unit Acquired WeaknessArmsPRECISe protocol EN 8g protein/100kcal, PRECISe protocol EN 5g protein/100kcal
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 15 institutions in 4 countries.

Rob J J van GasselDepartment of Intensive Care Medicine, Maastricht University Medical Center, Maastricht, the Netherlands.
Julia L M BelsDepartment of Intensive Care Medicine, Maastricht University Medical Center, Maastricht, the Netherlands. julia.bels@mumc.nl.ORCID http://orcid.org/0000-0001-9190-1661
Katrien TartagliaClinical Trial Unit, Ziekenhuis Oost-Limburg, Genk, Belgium.
Bas C T van BusselDepartment of Intensive Care Medicine, Maastricht University Medical Center, Maastricht, the Netherlands.
Sander M J van KuijkDepartment of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, the Netherlands.
Adam M DeaneDepartment of Critical Care, Melbourne Medical School, University of Melbourne, Parkville, Australia.
Zudin PuthuchearyWilliam Harvey Research Institute, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, London, UK.
Peter J M WeijsDepartment of Nutrition and Dietetics, Faculty of Sports and Nutrition, Amsterdam University of Applied Sciences, Amsterdam, the Netherlands.
Lilian VloetResearch Department of Emergency and Critical Care, HAN University of Applied Science, School of Health Studies, Nijmegen, the Netherlands.
Bert BeishuizenDepartment of Intensive Care Medicine, Medisch Spectrum Twente, Enschede, the Netherlands.
Ashley De Bie DekkerDepartment of Intensive Care, Catharina Hospital, Eindhoven, the Netherlands.
Vincent FraipontService of Intensive Care Medicine, Citadelle Hospital, Liège, Belgium.
Stoffel LamoteDepartment of Intensive Care Medicine, AZ Groeninge, Kortrijk, Belgium.
Didier LedouxSensation & Perception Research Group, GIGA Consciousness, University of Liège, Liège, Belgium.
Clarissa ScheerenDepartment of Intensive Care Medicine, Zuyderland Medisch Centrum, Heerlen/Sittard, the Netherlands.
Elisabeth De WaeleDepartement of Nutrition, Universitair Ziekenhuis Brussel, Jette, Belgium.
Arthur R H van ZantenDepartment of Intensive Care, Gelderse Vallei Hospital, Ede, the Netherlands.
Dieter Mesotten *Department of Intensive Care Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium.
Marcel C G van de Poll *Department of Intensive Care Medicine, Maastricht University Medical Center, Maastricht, the Netherlands.
Maastricht University · NLZiekenhuis Oost-Limburg · BEAmsterdam University of Applied Sciences · NLAZ Groeninge · BECentre hospitalier régional de la Citadelle · BEHAN University of Applied Sciences · NLMaastricht University Medical Centre · NLMedisch Spectrum Twente · NLQueen Mary University of London · GBRadboud University Nijmegen · NLThe University of Melbourne · AUUniversitair Ziekenhuis Brussel · BEUniversity of Liège · BEZiekenhuis Gelderse Vallei · NLZuyderland Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCritically ill patients are subject to severe skeletal muscle wasting during intensive care unit (ICU) stay, resulting in impaired short- and long-term functional outcomes and health-related quality of life. Increased protein provision may improve functional outcomes in ICU patients by attenuating skeletal muscle breakdown. Supporting evidence is limited however and results in great variety in recommended protein targets.

methodsThe PRECISe trial is an investigator-initiated, bi-national, multi-center, quadruple-blinded randomized controlled trial with a parallel group design. In 935 patients, we will compare provision of isocaloric enteral nutrition with either a standard or high protein content, providing 1.3 or 2.0 g of protein/kg/day, respectively, when fed on target. All unplanned ICU admissions with initiation of invasive mechanical ventilation within 24 h of admission and an expected stay on ventilator support of at least 3 days are eligible. The study is designed to assess the effect of the intervention on functional recovery at 1, 3, and 6 months following ICU admission, including health-related quality of life, measures of muscle strength, physical function, and mental health. The primary endpoint of the trial is health-related quality of life as measured by the Euro-QoL-5D-5-level questionnaire Health Utility Score. Overall between-group differences will be assessed over the three time points using linear mixed-effects models. DISCUSSION: The PRECISe trial will evaluate the effect of protein on functional recovery including both patient-centered and muscle-related outcomes.

trial registrationClinicalTrials.gov Identifier: NCT04633421 . Registered on November 18, 2020. First patient in (FPI) on November 19, 2020. Expected last patient last visit (LPLV) in October 2023.

Indexed as

Quality of LifeRespiration, ArtificialCritical CareCritical IllnessHumansIntensive Care UnitsMulticenter Studies as TopicRandomized Controlled Trials as TopicRecovery of FunctionTimeCritical illnessDietary proteinEnteral nutritionFunctional outcomesNutrition therapy

Identifiers

PMID37337234
PMCPMC10280915
OpenAlexW4381190522

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.