An interventional study of low-calorie low-protein and standard-calorie/standard-protein in Critical Illness, Shock and Mechanical Ventilation, sponsored by Nantes University Hospital. Completed at 59 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Supportive care
Among critically ill patients requiring mechanical ventilation and catecholamines for shock, nearly 40% to 50% die, and functional recovery is often delayed in survivors. International guidelines include early nutritional support (≤48 h after admission), 20-25 kcal/kg/d at the acute phase, and 1.2-2 g/kg/d protein. These targets are rarely achieved in patients with severe critically illnesses. Recent data challenge the wisdom of providing standard amounts of calories and protein during the acute phase of critical illness. Studies designed to improve enteral nutrition delivery showed no outcome benefits with higher intakes. Instead, adding parenteral nutrition to increase intakes was associated with longer ICU stays and more infectious complications. Studies suggest that higher protein intakes during the acute phase may be associated with greater muscle wasting and ICU-acquired weakness. The optimal calorie and protein supply at the acute phase of severe critical illness remains unknown. NUTRIREA-3 will be the first trial to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding potentially associated with improved muscle preservation, translating into shorter mechanical ventilation and ICU-stay durations, lower ICU-acquired infection rates, lower mortality, and better long-term clinical outcomes. This multicentre, randomized, controlled, open trial will compare, in patients receiving mechanical ventilation and treated with vasoactive agent for shock two strategies for initiating nutritional support at the acute phase of ICU management (D0-D7): early calorie/protein restriction (6 kcal/kg/d/0.2-0.4 g/kg/d, Low group) or standard calorie/protein targets (25 kcal/kg/d/1.0-1.3 g/kg/d, Standard group). Patients in both groups will receive enteral or parenteral nutrition appropriate for their critical illness. Two alternative primary end-points will be evaluated: all-cause mortality by day 90 and time to discharge alive from the ICU. Second end-points will be calories and proteins delivered, nosocomial infections, gastro-intestinal complications, glucose control, liver dysfunctions, muscle function at the time of readiness for ICU discharge and quality of life at 3 months and 1 year after study inclusion.
487 studies on the registry are indexed under Shock; 107 are open to participants now.
This study's enrollment of 3,044 is above the median of 100 across 229 interventional studies indexed under Shock.
Browse Shock studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
Compared within Shock, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients randomized in the "low group" will receive a low-calorie low-protein nutrition regimen during the acute phase.
Procedure: low-calorie low-protein
Patients randomized in the "standard group" will receive a standard-calorie/standard-protein nutrition regimen during the acute phase.
Procedure: standard-calorie/standard-protein
In the low-calorie low-protein (Low) group, the calorie target will be 6 kcal/kg/day and the protein target 0.2-0.4 g/kg/d during the acute phase, i.e. from D0 to D7. On D8, the calorie target will be 30 kcal/kg/d and the protein target 1.2-2.0 g/kg/d.
In the standard-calorie/standard-protein (Standard) group, the first-line calorie target calculated based on body weight is 25 kcal/kg/day and the protein target 1.0-1.3 g/kg/d during the acute phase, i.e. from D0 to D7. On D8, the calorie target will be 30 kcal/kg/d and the protein target 1.2-2.0 g/kg/d.
Time to discharge alive from the ICU.
A patient will be considered ready for ICU discharge by the bedside physicians as soon as all predefined clinical conditions for ICU discharge are fulfilled, regardless of ward-bed availability.
Time frame: From date of ICU admission until the date of first documented date when predefined clinical conditions for ICU discharge are fulfilled, an average of 10 days.
D-90 mortality
All-cause mortality by day 90
Time frame: 90 days
Number of calories (in kcal) delivered daily enterally and/or parenterally
Time frame: from day 0 to day 7
Ratio of prescribed over calories delivered
Ratio (as a %) of prescribed over calories delivered daily enterally and/or parenterally
Time frame: from day 0 to day 7
Proportion of patients who achieved their calorie target
Proportion of patients who achieved their calorie target
Time frame: from day 0 to day 7
Protein supply
Protein supply (g) given daily enterally and/or parenterally
Time frame: from day 0 to day 7
Volume of fluids
Volume of fluids (in mL) received daily
Time frame: from day 0 to day 7
Changes in Sequential Organ Failure Assessment (SOFA) score
SOFA scores can range from 0 (no organ failure) to 24 (most severe level of multi-organ failure).
Time frame: from day 0 to day 7
Changes in daily maximum blood glucose levels
Time frame: from day 0 to day 7
Proportion of patients with hypoglycaemia
Time frame: from day 0 to day 7
insulin dose
Total insulin dose received daily
Time frame: from day 0 to day 7
insulin treatment
Days on insulin treatment
Time frame: from day 0 to readiness for ICU discharge, an average of 10 days
Proportion of patients with at least one ICU-acquired infection.
Time frame: from day 0 to readiness for ICU discharge, an average of 10 days
Proportion of patients with each type ICU-acquired infection
e.g. (Ventilator-associated pneumonia, bacteremia, Central venous catheter-related infections, Urinary tract infections, soft tissue infections).
Time frame: from day 0 to readiness for ICU discharge, an average of 10 days
Proportion of patients with at least one episode of vomiting or regurgitation while on mechanical ventilation
Time frame: from day 0 to extubation, an average of 7 days
Proportion of patients with at least one episode of liver dysfunction during follow-up
Time frame: from day 0 to readiness for ICU discharge, an average of 10 days
Proportion of patients with at least one episode of diarrhoea
defined as liquid stools in a volume greater than 300 mL/24 hours in patients with a faecal collector or as more than four loose stools/24 hours
Time frame: from day 0 to extubation, an average of 7 days
Proportion of patients with at least one episode of constipation
no stool for more than 6 days
Time frame: from day 0 to extubation, an average of 7 days
Proportion of patients with at least one documented episode of bowel ischaemia
Time frame: from day 0 to readiness for ICU discharge, an average of 10 days
Mean changes in serum albumin
measured at baseline, at the end of mechanical ventilation, on day 7 (in patients on mechanical ventilation for more than 7 days), and at ICU discharge
Time frame: from day 0 to day 7 and readiness for ICU discharge, an average of 10 days
Mean changes in serum pre-albumin
measured at baseline, at the end of mechanical ventilation, on day 7 (in patients on mechanical ventilation for more than 7 days), and at ICU discharge
Time frame: from day 0 to day 7 and readiness for ICU discharge, an average of 10 days
Changes in serum C-reactive protein (CRP)
measured at baseline, at the end of mechanical ventilation, on day 7 (in patients on mechanical ventilation for more than 7 days), and at ICU discharge
Time frame: from day 0 to day 7 and readiness for ICU discharge, an average of 10 days
Changes in mean body weight
determined at baseline, on day 7, and at ICU discharge
Time frame: from day 0 to day 7 and readiness for ICU discharge, an average of 10 days
Hospital stay
Hospital stay length (days in hospital)
Time frame: from day 0 to hospital discharge, an average of 23 days
Duration of mechanical ventilation
Days on mechanical ventilation
Time frame: from day 0 to extubation, an average of 7 days
ICU mortality
Proportions of patients dead during the ICU stay
Time frame: from day 0 to ICU discharge, an average of 23 days
Mortality at day 28
Proportions of patients dead until day 28 after randomization
Time frame: from day 0 to day 28
Hospital mortality
Proportions of patients dead during the hospital stay
Time frame: from day 0 to hospital discharge, an average of 23 days
Proportions of patients mobilized
Evaluation of mobilisation during the ICU stay using predetermined criteria.
Time frame: from day 0 to day 7
Total number of active mobilizations
Evaluation of mobilisation during the ICU stay using predetermined criteria.
Time frame: from day 0 to day 7
Muscle function
Muscle function at the time of readiness for ICU discharge as assessed with the Medical Research Council (MRC) score. The MRC score ranges from 0 (no muscle activity) to 60 (normal muscle function).
Time frame: On the day of readiness for ICU discharge, an average of 10 days
Proportion of patients with at least one criterion for persistent altered health status
at the time of readiness for ICU discharge
Time frame: On the day of readiness for ICU discharge, an average of 10 days
SF-36 score
The Short Form (SF)-36 is a multipurpose health survey with 36 questions. Questionnaires will be completed during a phone call to the patient by an independent blinded research nurse or psychologist.
Time frame: 3 months and 1 year after study inclusion
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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