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Completed

NCT Number: NCT04633421

PRotEin Provision in Critical IllneSs

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.

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Key information

Conditions

Critical Illness Disease Attributes Intensive Care Unit Acquired Weakness Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

PRECISe protocol EN 8g protein/100kcal

Dietary Supplement

Enteral feed containing 8g protein/100kcal

PRECISe protocol EN 5g protein/100kcal

Dietary Supplement

Enteral feed containing 5g protein/100kcal

Primary outcomes

  1. Health Related Quality of Life (HRQL)

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

    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.

Secondary outcomes

  1. Overall survival

    Time frame: Day 30, 90 and 180 after ICU admission

    Overall survival

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

    Time frame: Day 30, 90 and 180 after ICU admission

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

  3. Mental health status - anxiety/depression

    Time frame: Day 30, 90 and 180 after ICU admission

    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.

  4. Pain intensity

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

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

  5. Self-reported health

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

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

  6. Mental health status - post-traumatic stress

    Time frame: Day 30, 90 and 180 after ICU admission.

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

  7. Physical function - 6-minute walk test

    Time frame: Day 30, 90 and 180 after ICU admission

    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.

  8. Muscle and nerve function - MRC-sum score

    Time frame: Day 30, 90 and 180 after ICU admission

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

  9. Muscle and nerve function - handgrip strength

    Time frame: Day 30, 90 and 180 after ICU admission.

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

Other outcomes

  1. Duration of mechanical ventilation

    Time frame: During index ICU stay, up to 90 days.

    Number of days on invasive mechanical ventilation.

  2. Duration of index ICU stay

    Time frame: During index ICU stay, up to 90 days.

    Number of days in ICU.

  3. Duration of index hospital stay

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

    Number of days in hospital.

  4. Hospital mortality

    Time frame: From index ICU admission until index hospital discharge, assessed up to 6 months.

    Hospital mortality

  5. 30-day mortality

    Time frame: From index ICU admission until day 30.

    Mortality at 30 days after ICU admission.

  6. 60-day mortality

    Time frame: From index ICU admission until day 60.

    Mortality at 60 days after ICU admission.

  7. 90-day mortality

    Time frame: From index ICU admission until day 90.

    Mortality at 90 days after ICU admission.

  8. Time-to-discharge-alive

    Time frame: From index ICU admission until index hospital discharge, assessed up to 6 months.

    Days until live hospital discharge

  9. Days alive and at home at day 90

    Time frame: From index ICU admission until day 90.

    Number of days alive and at home at day 90 after ICU admission.

  10. Nutritional adequacy

    Time frame: From index ICU admission until index ICU discharge, assessed up to 6 months.

    Ratio between total amount of calories and grams of protein actually received by patients and prescribed during treatment period.

  11. Administration of prokinetics

    Time frame: During index ICU stay, up to 90 days.

    Number of patients who received a prokinetic and number of days on it.

  12. Incidence of gastrointestinal intolerance/symptoms

    Time frame: During index ICU stay, up to 90 days.

    Number of patients that experienced gastrointestinal intolerance or symptoms at any time during index ICU stay, i.e. vomiting, ischemia, diarrhea, abdominal distention, gastric paresis, bleeding/ulcer.

  13. Incidence of ICU-readmission

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

    Number of patients readmitted to the ICU during index hospital stay and number of readmissions per patient.

  14. Incidence of ICU-acquired infections

    Time frame: During index ICU stay, up to 90 days.

    Number of patients who contracted an ICU-acquired infection.

  15. Incidence of acute kidney injury

    Time frame: During index ICU stay, up to 90 days.

    Number of patients with Acute Kidney Injury (AKI), defined as a serum creatinine level higher than 2 times baseline level.

  16. Incidence and duration of renal replacement therapy

    Time frame: During index ICU stay, up to 90 days.

    Number of patients who received renal replacement therapy and days on it.

  17. Incidence of hepatic dysfunction

    Time frame: During index ICU stay, up to 90 days.

    Number of patients with hepatic dysfunction, defined as a total bilirubin level > 3mg/dL.

  18. Maximum and mean SOFA score

    Time frame: During index ICU stay, up to 90 days.

    Sequential Organ Failure Assessment score (SOFA), ranging from 0 to 24. A higher score indicates more severe multi-organ failure.

  19. Difference in mobilization treatment

    Time frame: During index ICU stay, up to 90 days.

    Number of days and degree of daily mobilization (passive/active, in-bed cycling etc).

  20. Difference in frailty

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

    Rockwood Clinical Frailty Scale, ranging from 1 to 9, corrected for baseline. A higher score indicates a more severe degree of frailty.

  21. Domain data EQ-5D

    Time frame: Day 30, 90 and 180 after ICU admission.

    Scores of subdomains of EQ-5D, ranging from 1 to 5. A higher score indicates a higher severity level on that subdomain.

  22. Destination of hospital discharge

    Time frame: Follow-up until 180 days after index ICU admission.

    Destination of hospital discharge (home, rehabilitation center, care facility etc).

  23. Length of stay at rehabilitation facility

    Time frame: Follow-up until 180 days after index ICU admission.

    Number of days at rehabilitation center.

  24. Time to return to work

    Time frame: Follow-up until 180 days after index ICU admission.

    Number of days between ICU admission and return to work.

  25. Health economic analysis

    Time frame: From index ICU admission until 180 days.

    Total health care costs.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Catharina Ziekenhuis Eindhoven
  • Centre Hospitalier Régional de la Citadelle
  • Centre Hospitalier Universitaire de Liege
  • Gelderse Vallei Hospital
  • General Hospital Groeninge
  • Medisch Spectrum Twente
  • Universitair Ziekenhuis Brussel
  • Ziekenhuis Oost-Limburg
  • Zuyderland Medisch Centrum

Registry information

Official study 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

Acronym: PRECISe

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2020
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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