PRotEin Provision in Critical IllneSs
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
| Sponsors |
Lead Sponsor: Maastricht University Medical Center Collaborator:
Ziekenhuis Oost-Limburg
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| Source | Maastricht University Medical Center |
| 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 824 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. |
| 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. |
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| Overall Status | Recruiting | ||||||||||||||||||||
| Start Date | 2020-11-19 | ||||||||||||||||||||
| Completion Date | 2023-05-01 | ||||||||||||||||||||
| Primary Completion Date | 2023-05-01 | ||||||||||||||||||||
| Phase | N/A | ||||||||||||||||||||
| Study Type | Interventional | ||||||||||||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 824 |
| Condition | |
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| Intervention |
Intervention Type: Dietary Supplement Intervention Name: PRECISe protocol EN 8g protein/100kcal Description: Enteral feed containing 8g protein/100kcal Arm Group Label: PRECISe protocol EN (8g protein/100kcal) Intervention Type: Dietary Supplement Intervention Name: PRECISe protocol EN 5g protein/100kcal Description: Enteral feed containing 5g protein/100kcal Arm Group Label: PRECISe protocol EN (5g protein/100kcal) |
| Eligibility |
Criteria:
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 Gender: All Minimum Age: 18 Years Maximum Age: N/A Healthy Volunteers: No |
| Overall Official |
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| Overall Contact |
Last Name: Julia LM Bels, MD Phone: 06 30480685 Phone Ext.: +31 Email: [email protected] |
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| Location |
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| Location Countries |
Belgium Netherlands |
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| Verification Date |
2021-03-01 |
| Responsible Party |
Type: Sponsor |
| Keywords | |
| Has Expanded Access | No |
| Condition Browse | |
| Number Of Arms | 2 |
| Arm Group |
Label: PRECISe protocol EN (8g protein/100kcal) Type: Experimental Description: 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. Label: PRECISe protocol EN (5g protein/100kcal) Type: Active Comparator Description: Enteral (EN) feed with 5 grams protein per 100 kcal (1.2 g/kg/day protein when on target). The caloric goal is 25 kcal/kg/day to be reached on day 4 of ICU admission. |
| Acronym | PRECISe |
| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: 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. |
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