NCT05603585

Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients

Attenuation of Sarcopenia Using Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients: A Pilot Randomized Controlled Trial (PIVOT)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

A Pilot Randomized Controlled Trial (RCT) will be conducted where where mechanically ventilated patients will be randomized to optimal protein (Achieve 80% protein supplementation adequacy with daily titration) versus standard protein feeding. Both groups will receive standard usual early exercise therapy. Specific aim 1: To determine if optimal protein supplementation improves functional outcome of patients as measured by Functional Status Score (FSS) on Day 7. Specific aim 2: To determine if optimal protein supplementation reduces muscle loss of patients at Day 7 as measured by the Rectus Femoris thickness and cross-sectional area (RFCSA) using skeletal muscle ultrasound. Specific aim 3: To determine difference in functional recovery between groups using quality of life (QOL) scores and 6-minute walk distance at 3 months after hospital discharge. The hypothesis is protein inadequacy can be overcome with optimized protein supplementation to reduce muscle loss/sarcopenia and functional impairment in ICU survivors.

Detailed description

This study will be a prospective pilot randomized controlled trial. Collaboration will be between the National University Hospital (Medical, Surgical and Cardiothoracic ICUs), Centre for Healthy Aging, National University Health System (NUHS) and Physical Education \& Sports Science, National Institute of Education (NIE). Patients admitted into these ICUs will be screened and those meeting the inclusion criteria will be approached for consent. If the patient is unable to consent, his/her legally acceptable representatives will be approached. This approach is routinely done in ICU studies. As with other ICU studies, potential difficulties in consenting and recruiting patients will be expected. To overcome this, all adult ICU patients at NUH will be included in the current study.

Conditions

• Nutritional Deficiency
• Cachexia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Optimal protein supplementation to achieve 80% protein adequacy.	Additional protein required and delivered by adding protein powder and given in bolus feeds

Timeline

• Start date: 2022-09-06
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2022-11-02
• Last updated: 2023-08-01

Locations

1 site across 1 country: Singapore