Attenuation of Sarcopenia Using Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients: A Pilot Randomized Controlled Trial (PIVOT)
Sponsor study identifier
interventional
150
1 country
1
Study Start
September 6, 2022
Actual (reported)Primary Completion
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 6, 2022
Actual (reported)September 19, 2022
Actual (reported)November 2, 2022
Actual (reported)September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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)
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.
Additional protein required and delivered by adding protein powder and given in bolus feeds
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
National University Hospital
Singapore, 119074, Singapore
Geetha Kayambu
National University Hospital, Singapore
First Submitted
September 19, 2022
First Posted
November 2, 2022
Study Start
September 6, 2022
Contact the study team to confirm eligibility.
Primary Completion
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 1, 2023
Record last verified: 2022-11
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: