An interventional study of Optimal protein supplementation to achieve 80% protein adequacy. in Nutritional Deficiency and Cachexia, sponsored by National University Hospital, Singapore. Status unknown at 1 site in Singapore. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Prevention
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.
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.
1,619 studies on the registry are indexed under Malnutrition; 241 are open to participants now.
This study's planned enrollment of 150 is above the median of 90 across 1,152 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →National University Hospital, Singapore is the lead sponsor of 451 studies on the registry; 96 are open to participants now.
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Exclusion Criteria:
Standard care as per current ICU feeding regime.
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.
Additional protein required and delivered by adding protein powder and given in bolus feeds
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.
Time frame: Day 1 of Randomisation; Day 7 of Randomisation; Day of ICU Discharge , approximately 14 days after ICU admission
Rectus Femoris Cross-Sectional Area (RFCSA) and anterior thigh and rectus femoris thickness
RFCSA correlates well with quadriceps strength, measured by B-mode ultrasonography using linear transducer array. Pennation angle will also be calculated. The rectus femoris RFCSA and thigh thickness and pennation angle is measured at day 1 upon recruitment and compared to day 4 and then day 7 of study recruitment to determine changes in muscle loss.
Time frame: 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)
Feasible standard measure of exercise capacity
Time frame: 3 months post hospital discharge
Clinical Frailty Index (CFI)
The CFI scoring is a scale from 1 to 9, 1 being very fit (best outcome) while 9 being terminally ill (worst outcome). The CFI is measured at day 1 upon recruitment and compared to point of ICU discharge to determine changes in frailty.
Time frame: Day 1 of Randomisation; Day of ICU Discharge , approximately 14 days after ICU admission
Blood Biomarkers
The following cytokines; IL-6, IL-10, IL-12 and TNF-1α and MCP1, HMGB1 will be analysed via blood test to monitor inflammatory reactions
Time frame: Day 1 of Randomisation; Day 4 of Randomisation
Indirect calorimetry (IC)
Gold standard for measurement of energy expenditure (EE)
Time frame: Day 1 to Day 7 of Randomisation (daily or till extubation)
Plan to share: No — Participants ID will be coded as study participant ID. Only the PI and the study administrator will have access to the key between the code and participant ID.
No publications or documents are linked to this record.
Started Sep 2022 (actual). Primary completion is estimated for Sep 2023, 12 months after the start.
Of 438 non-industry interventional studies with no phase under Malnutrition, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's planned 12 months is below that.
Counting every sponsor, half of 469 studies reached it within 20 months; a quarter within 10 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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