Clinical trial NCT05603585: Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients
Official title: Attenuation of Sarcopenia Using Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients: A Pilot Randomized Controlled Trial (PIVOT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutritional Deficiency
Cachexia
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
First posted: 2022-11-02
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomly assigned to receive either standard feeding or optimised protein feeding based on random permuted blocks with age (≥65 years or \< 65 years) and ICU site of recruitment as the stratification factors. The primary endpoint is difference in FSS between the two groups at Day 7.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age 21 years and above.
2. Expected mechanical ventilation duration ≥ 48 hours.
3. Expected to stay in hospital for ≥ 4 days.

Exclusion Criteria:

1. Pregnant woman.
2. Amputation of either lower limbs.
3. Surgery of lower limb during the current admission.
4. 4. Any neurological/rheumatologic/orthopaedic/burn/trauma/physiological problem with feeding difficulties during 48h of intubation
5. Wheelchair-bound, walking aids and ADL-dependent.
6. Patient not able to feed by 48 hours AND not given parenteral feeding.
7. Patients on Continuous Renal Replacement Therapy.
8. Sepsis with poor prognosis.
9. Competing trial
10. Moribund within 48hours.
11. COVID-19 patients.
12. Declined to participate the study

Primary outcomes:
measure: Functional Status Score for ICU (FSS-ICU)
timeFrame: Day 1 of Randomisation; Day 7 of Randomisation; Day of ICU Discharge , approximately 14 days after ICU admission
Secondary outcomes:
measure: Rectus Femoris Cross-Sectional Area (RFCSA) and anterior thigh and rectus femoris thickness
timeFrame: Day 1 of Randomisation; Day 4 of Randomisation; Day 7 of Randomisation; Day of ICU Discharge , approximately 14 days after ICU admission
measure: Six-Minute Walk Test (6MWT)
timeFrame: 3 months post hospital discharge
measure: Clinical Frailty Index (CFI)
timeFrame: Day 1 of Randomisation; Day of ICU Discharge , approximately 14 days after ICU admission
measure: Blood Biomarkers
timeFrame: Day 1 of Randomisation; Day 4 of Randomisation
measure: Indirect calorimetry (IC)
timeFrame: Day 1 to Day 7 of Randomisation (daily or till extubation)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Geetha Kayambu
role: PRINCIPAL_INVESTIGATOR
References: