PRotEin Provision in Critical IllneSs

NCT04633421 | Completed DMC

• 2 other identifiers: NL73247.068.2080-85200-98-18574
• Study Type: interventional
• Target: 935
• Locations: 2 countries
• Sites: 10

Brief 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. 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.

Conditions

Critical Illness; Intensive Care Unit Acquired Weakness

Keywords

Enteral Nutrition; Dietary Proteins; Respiratory failure; Catabolism

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (9)

• Overall survival

  Day 30, 90 and 180 after ICU admission

• Health-related Quality of Life - SF-36

  Day 30, 90 and 180 after ICU admission

• Mental health status - anxiety/depression

  Day 30, 90 and 180 after ICU admission

• Pain intensity

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

• Self-reported health

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

Other Outcomes (25)

• Duration of mechanical ventilation

  During index ICU stay, up to 90 days.

• Duration of index ICU stay

  During index ICU stay, up to 90 days.

• Duration of index hospital stay

  From date of randomization until the date of index hospital discharge, assessed up to 6 months.

Study Arms (2)

PRECISe protocol EN (8g protein/100kcal)

EXPERIMENTAL

Enteral (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.

Dietary Supplement: PRECISe protocol EN 8g protein/100kcal

PRECISe protocol EN (5g protein/100kcal)

ACTIVE COMPARATOR

Enteral (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.

Dietary Supplement: PRECISe protocol EN 5g protein/100kcal

Interventions

PRECISe protocol EN 8g protein/100kcal DIETARY_SUPPLEMENT

Enteral feed containing 8g protein/100kcal

PRECISe protocol EN (8g protein/100kcal)

PRECISe protocol EN 5g protein/100kcal DIETARY_SUPPLEMENT

Enteral feed containing 5g protein/100kcal

PRECISe protocol EN (5g protein/100kcal)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Ziekenhuis Oost-Limburg: collaborator
• Zuyderland Medisch Centrum: collaborator
• Gelderse Vallei Hospital: collaborator
• Medisch Spectrum Twente: collaborator
• Centre Hospitalier Universitaire de Liege: collaborator
• Centre Hospitalier Régional de la Citadelle: collaborator
• Universitair Ziekenhuis Brussel: collaborator
• General Hospital Groeninge: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator

Study Sites (10)

UZ Brussel

Brussels, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

AZ Groeninge

Kortrijk, Belgium

Location

CHR de la Citadelle

Liège, Belgium

Location

CHU Liège

Liège, Belgium

Location

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Gelderse Vallei Ede

Ede, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Zuyderland Medisch Centrum

Heerlen, Netherlands

Location

Maastricht Universtair Medisch Centrum

Maastricht, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 28537429 BACKGROUND

• 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.

  PMID: 40215884 DERIVED

• 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.

  PMID: 39153816 DERIVED

• 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.

  PMID: 37337234 DERIVED

MeSH Terms

Conditions

Critical Illness; Respiratory Insufficiency

Interventions

Proteins

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Marcel CG van de Poll, MD, PhD

  Maastricht UMC+

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study feeds will be blinded. Dosing of intervention will be volume based, with the same volume targets for both groups. Differences in composition of study feeds will result in differences in protein intake at similar volume administration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 18, 2020
• Study Start: November 19, 2020
• Primary Completion: October 3, 2023
• Study Completion: October 3, 2023
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

NL (5); BE (5)