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AzTrials

Critical IllnessPRECISeNCT04633421

PRotEin Provision in Critical IllneSs

A study testing PRECISe protocol EN 8g protein/100kcal and PRECISe protocol EN 5g protein/100kcal in people with Critical Illness and Intensive Care Unit Acquired Weakness, run by Maastricht University Medical Center at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Rapid skeletal muscle wasting during critical illness had a detrimental impact on both short and long term outcomes following ICU admission. Increased dietary protein delivery might attenuate skeletal muscle wasting and its subsequent effects on post-ICU function. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PRECISe protocol EN 8g protein/100kcal and PRECISe protocol EN 5g protein/100kcal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
935 participants
Where
10 sitesin 2 countries
Study dates
19 Nov 2020to 3 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

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 or above) patient admitted to the ICU
  • Unplanned ICU admission
  • Invasive mechanical ventilation initiated <24 hours of ICU admission
  • Expected ICU stay on ventilator support of 3 days or more

Who cannot join

  • Contraindication for enteral nutrition
  • Moribund or expected withholding of treatment
  • Kidney failure AND 'no-dialysis'-code on admission
  • Hepatic encephalopathy.(West Haven grade 3 or 4)
  • Body-mass index < 18 kg/m2

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

Belgium5 sites

  • UZ Brussel

    Brussels

  • Ziekenhuis Oost-Limburg

    Genk, 3600

  • AZ Groeninge

    Kortrijk

  • CHR de la Citadelle

    Liège

  • CHU Liège

    Liège

Other trials in Belgium

Netherlands5 sites

  • Gelderse Vallei Ede

    Ede

  • Catharina Ziekenhuis Eindhoven

    Eindhoven, North Brabant, 5623 EJ

  • Medisch Spectrum Twente

    Enschede

  • Zuyderland Medisch Centrum

    Heerlen

  • Maastricht Universtair Medisch Centrum

    Maastricht

Other trials in Netherlands

About this study

Official title: 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

Rapid skeletal muscle wasting during critical illness had a detrimental impact on both short and long term outcomes following ICU admission. Increased dietary protein delivery might attenuate skeletal muscle wasting and its subsequent effects on post-ICU function.

The investigators will conduct a 935 patient, randomised controlled, quadruple blinded parallel group trial to determine whether enteral nutrition with increased protein content in mechanically ventilated, critically ill patients is able to improve functional recovery.

Read the detailed description

ICU-acquired weakness (ICU-AW) is frequent among ICU survivors and negatively affects both short and long term outcomes. ICU-AW is the consequence of the body's reserves being depleted during critical illness and results in severe skeletal muscle wasting during the first week of ICU admission.Therefore, measures aimed at preserving muscle mass during critical illness and improving recovery after ICU discharge are urgently needed.

Retrospective observational cohort studies suggest that the administration of high protein nutrition is associated with improved survival and outcome. Current ICU guidelines recommend dietary protein delivery at 1.3 g/kg/day (ESPEN), or even up to 2.0 g/kg/day (ASPEN). However, strong prospective clinical evidence on the effectiveness and safety of high enteral protein delivery is lacking and urgently awaited. Therefore, the aim of the present study is to investigate the effect of high versus standard protein provision on the functional recovery of critically ill patients.

The focus on functional, patient-centered outcomes rather than traditional clinical endpoints like mortality is an important aspect and strength of the study. Previous nutritional intervention studies focusing primarily on improving mortality have repeatedly shown no effect. Therefore, it is nowadays increasingly recognized to move primary ICU trial endpoints away from classical outcomes, such as survival or length of stay, towards more functional outcomes, in line with the underlying pathophysiology.

Being tested
PRECISe protocol EN 8g protein/100kcal, PRECISe protocol EN 5g protein/100kcal
Keywords
Enteral Nutrition, Dietary Proteins, Respiratory failure, Catabolism
Medical subject headings
Critical Illness, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRECISe protocol EN 8g protein/100kcalDietary supplement

    Enteral feed containing 8g protein/100kcal

  • PRECISe protocol EN 5g protein/100kcalDietary supplement

    Enteral feed containing 5g protein/100kcal

Study groups in NCT04633421
Study groupRoleWhat they receive
PRECISe protocol EN (8g protein/100kcal)ExperimentalEnteral (EN) feed with 8 grams protein per 100 kcal (2.0 g/kg/day protein when on target). The caloric goal is 25 kcal/kg/day to be reached on day 4 of ICU admission.
Receives: Dietary Supplement: PRECISe protocol EN 8g protein/100kcal
PRECISe protocol EN (5g protein/100kcal)Active comparatorEnteral (EN) feed with 5 grams protein per 100 kcal (1.3 g/kg/day protein when on target). The caloric goal is 25 kcal/kg/day to be reached on day 4 of ICU admission.
Receives: Dietary Supplement: PRECISe protocol EN 5g protein/100kcal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health Related Quality of Life (HRQL)

    Overall difference in EQ-5D single summary index between intervention and control group over the three time-points combined, corrected for baseline. A higher summary index indicates better Health related Quality of Life.

    Measured: Day 0, Day 30, 90 and 180 after index ICU admission.

Secondary outcomes (9)

  1. Overall survival

    Overall survival

    Measured: Day 30, 90 and 180 after ICU admission

  2. Health-related Quality of Life - SF-36

    Short Form 36 (SF-36), ranging from 0 to 100. A higher score indicates a better Health-related Quality of Life.

    Measured: Day 30, 90 and 180 after ICU admission

  3. Mental health status - anxiety/depression

    Hospital Anxiety and Depression Scale (HADS), ranging from 0 to 42. Questions 1, 3, 5, 7, 9, 11 and 13 measure symptoms of anxiety (range: 0-21). Questions 2, 4, 6, 8, 10, 12 and 14 measure symptoms of depression (range: 0-21). Higher scores indicate worse symptoms of anxiety and depression.

    Measured: Day 30, 90 and 180 after ICU admission

  4. Pain intensity

    EQ-5D pain question, ranging from 1 to 5, corrected for baseline. A higher score indicates a more severe perception of pain.

    Measured: Day 0, Day 30, 90 and 180 after index ICU admission

  5. Self-reported health

    EQ-5D Visual Analogue Scale (EQ-VAS), ranging from 0 to 100. A higher score indicates a better self-reported health.

    Measured: Day 0, Day 30, 90 and 180 after index ICU admission

  6. Mental health status - post-traumatic stress

    Impact of Event Scale Revised (IES-R), ranging from 0 to 88. A higher score indicates worse symptoms of Post-Traumatic Stress Disorder.

    Measured: Day 30, 90 and 180 after ICU admission.

  7. Physical function - 6-minute walk test

    6-minute walk test. Data collected during 6-minute walk test are pre- and post-test saturation and pulse and total distance walked with or without the use of any aids.

    Measured: Day 30, 90 and 180 after ICU admission

  8. Muscle and nerve function - MRC-sum score

    Medical Research Council (MRC-)sum score, ranging from 0 to 60. A higher score indicates better muscle and nerve function.

    Measured: Day 30, 90 and 180 after ICU admission

  9. Muscle and nerve function - handgrip strength

    Handgrip strength, assessed via a hand dynamometer and measured in kilograms (kg).

    Measured: Day 30, 90 and 180 after ICU admission.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2020
  2. Study start19 Nov 2020
  3. Primary completion3 Oct 2023
  4. Study completion3 Oct 2023

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
935 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04633421
Sponsor's protocol ID
NL73247.068.20
Other IDs
80-85200-98-18574
Acronym
PRECISe
Status last verified
Jan 2024
First submitted
23 Oct 2020
Last updated
22 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Needham DM, Sepulveda KA, Dinglas VD, Chessare CM, Friedman LA, Bingham CO 3rd, Turnbull AE. Core Outcome Measures for Clinical Research in Acute Respiratory Failure Survivors. An International Modified Delphi Consensus Study. Am J Respir Crit Care Med. 2017 Nov 1;196(9):1122-1130. doi: 10.1164/rccm.201702-0372OC.

    PubMed 28537429

  • Schouteden E, Heuts S, Bels JL, Thiesen S, van Gassel RJ, Lee ZY, Stoppe C, Beishuizen A, De Bie Dekker A, Fraipont V, Lamote S, Ledoux D, Scheeren C, De Waele E, van Zanten A, van Kuijk SM, van de Poll MC, Mesotten D, Gabrio A; PRECISe study team. The impact of high versus standard enteral protein provision on functional recovery following intensive care admission: A pre-planned Bayesian analysis of the PRECISe trial. Clin Nutr. 2025 May;48:153-160. doi: 10.1016/j.clnu.2025.03.022. Epub 2025 Apr 1.

    PubMed 40215884

  • Bels JLM, Thiessen S, van Gassel RJJ, Beishuizen A, De Bie Dekker A, Fraipont V, Lamote S, Ledoux D, Scheeren C, De Waele E, van Zanten ARH, Bormans-Russell L, van Bussel BCT, Dictus MMJ, Fivez T, Harks I, van der Horst ICC, Jonckheer J, Marechal H, Massion PB, Meex I, Paulus MC, Rinket M, van Santen S, Tartaglia K, Deane AM, Demuydt F, Puthucheary Z, Vloet LCM, Weijs PJM, van Kuijk SMJ, van de Poll MCG, Mesotten D; PRECISe study team. Effect of high versus standard protein provision on functional recovery in people with critical illness (PRECISe): an investigator-initiated, double-blinded, multicentre, parallel-group, randomised controlled trial in Belgium and the Netherlands. Lancet. 2024 Aug 17;404(10453):659-669. doi: 10.1016/S0140-6736(24)01304-7.

    PubMed 39153816

  • van Gassel RJJ, Bels JLM, Tartaglia K, van Bussel BCT, van Kuijk SMJ, Deane AM, Puthucheary Z, Weijs PJM, Vloet L, Beishuizen B, De Bie Dekker A, Fraipont V, Lamote S, Ledoux D, Scheeren C, De Waele E, van Zanten ARH, Mesotten D, van de Poll MCG. 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. Trials. 2023 Jun 19;24(1):416. doi: 10.1186/s13063-023-07380-3.

    PubMed 37337234

Questions about this trial

What is this clinical trial studying?

A study testing PRECISe protocol EN 8g protein/100kcal and PRECISe protocol EN 5g protein/100kcal in people with Critical Illness and Intensive Care Unit Acquired Weakness, run by Maastricht University Medical Center at 10 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 5 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: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health Related Quality of Life (HRQL) (time frame: Day 0, Day 30, 90 and 180 after index ICU admission.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04633421, which also lists 4 linked publications.

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 22 Jan 2024.

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