Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients

NCT05603585 | Unknown DMC

• 1 other identifier: 2021/00201
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Deficiency; Cachexia

Outcome Measures

Primary Outcomes (1)

• Functional Status Score for ICU (FSS-ICU)

  It is an ordinal score consisting of 5 activities (namely, Rolling in bed, Supine to Sit Transfer, Sit to Stand Transfer, Sitting Edge of Bed, Walking); each activity is scored from 0 to 7 to a total of 35. A higher score indicates a better functioning. It closely resembles Activities of Daily Living (ADL) and it is possible to even measure the pre-admission score. The FSS-ICU is measured at day 1 upon recruitment and compared to a one week period and to the time of discharge in intensive care to determine functional improvements at these time points.

  Day 1 of Randomisation; Day 7 of Randomisation; Day of ICU Discharge , approximately 14 days after ICU admission

Secondary Outcomes (5)

• Rectus Femoris Cross-Sectional Area (RFCSA) and anterior thigh and rectus femoris thickness

  Day 1 of Randomisation; Day 4 of Randomisation; Day 7 of Randomisation; Day of ICU Discharge , approximately 14 days after ICU admission

• Six-Minute Walk Test (6MWT)

  3 months post hospital discharge

• Clinical Frailty Index (CFI)

  Day 1 of Randomisation; Day of ICU Discharge , approximately 14 days after ICU admission

• Blood Biomarkers

  Day 1 of Randomisation; Day 4 of Randomisation

• Indirect calorimetry (IC)

  Day 1 to Day 7 of Randomisation (daily or till extubation)

Study Arms (2)

Control Group

NO INTERVENTION

Standard care as per current ICU feeding regime.

Interventional Group

EXPERIMENTAL

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.

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

Interventions

Optimal protein supplementation to achieve 80% protein adequacy. DIETARY_SUPPLEMENT

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

Interventional Group

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

MeSH Terms

Conditions

Malnutrition; Cachexia

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Geetha Kayambu

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geetha Kayambu

CONTACT

6779 5555; geetha_kayambu@nuhs.edu.sg

Lian Ting Wong

CONTACT

lian_ting_wong@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants and their legally acceptable representative will not be made known of the experimental arms that the participant is allocated to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: November 2, 2022
• Study Start: September 6, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 1, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)