Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-06

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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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

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Nutritional Deficiency Cachexia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

The participants and their legally acceptable representative will not be made known of the experimental arms that the participant is allocated to.

Study Groups

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Control Group

Standard care as per current ICU feeding regime.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventional Group

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.

Group Type EXPERIMENTAL

Optimal protein supplementation to achieve 80% protein adequacy.

Intervention Type DIETARY_SUPPLEMENT

Additional protein required and delivered by adding protein powder and given in bolus feeds

Interventions

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Optimal protein supplementation to achieve 80% protein adequacy.

Additional protein required and delivered by adding protein powder and given in bolus feeds

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No