TY - JOUR
T1 - The impact of high versus standard enteral protein provision on functional recovery following intensive care admission (PRECISE trial)
T2 - study protocol for a randomized controlled, quadruple blinded, multicenter, parallel group trial in mechanically ventilated patients
AU - van Gassel, Rob J. J.
AU - Bels, Julia L. M.
AU - Tartaglia, Katrien
AU - van Bussel, Bas C. T.
AU - van Kuijk, Sander M. J.
AU - Deane, Adam M.
AU - Puthucheary, Zudin
AU - Weijs, Peter J. M.
AU - Vloet, Lilian
AU - Beishuizen, Bert
AU - De Bie Dekker, Ashley
AU - Fraipont, Vincent
AU - Lamote, Stoffel
AU - Ledoux, Didier
AU - Scheeren, Clarissa
AU - De Waele, Elisabeth
AU - van Zanten, Arthur R. H.
AU - Mesotten, Dieter
AU - van de Poll, Marcel C. G.
PY - 2023/6/19
Y1 - 2023/6/19
N2 - Background Critically 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.Methods The 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.
AB - Background Critically 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.Methods The 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.
KW - Enteral nutrition
KW - Nutrition therapy
KW - Dietary protein
KW - Critical illness
KW - Functional outcomes
KW - CRITICALLY-ILL
KW - IMPORTANT DIFFERENCE
KW - NUTRITION
KW - OUTCOMES
KW - EQUATIONS
KW - THERAPY
KW - SUPPORT
KW - ADULTS
KW - VOLUME
KW - INDEX
U2 - 10.1186/s13063-023-07380-3
DO - 10.1186/s13063-023-07380-3
M3 - Article
C2 - 37337234
SN - 1745-6215
VL - 24
JO - Trials
JF - Trials
IS - 1
M1 - 416
ER -