Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients

National University Health System (NUHS)

Status: Enrolling

Conditions: Cachexia; Nutritional Deficiency

Treatments: Dietary Supplement: Optimal protein supplementation to achieve 80% protein adequacy.

Study type: Interventional

Funder types: Other

Identifiers

NCT05603585

2021/00201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Control Group

No Intervention group

Description:

Standard care as per current ICU feeding regime.

Interventional Group

Experimental group

Description:

Optimal protein supplementation to achieve 80% protein adequacy through optimised protein supplementation. The protein supplementation will be increased/decreased based on the previous day's intake to achieve 80% adequacy each day by the dietician.

Treatment:

Dietary Supplement: Optimal protein supplementation to achieve 80% protein adequacy.