Nutritional DeficiencyNCT05603585
Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients
A study testing Optimal protein supplementation to achieve 80% protein adequacy. in people with Nutritional Deficiency and Cachexia, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Nutritional Deficiency, Cachexia
- What is being tested?
- Optimal protein supplementation to achieve 80% protein adequacy.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSingapore
- Study dates
- 6 Sep 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 years and above.
- Expected mechanical ventilation duration ≥ 48 hours.
- Expected to stay in hospital for ≥ 4 days.
Who cannot join
- Pregnant woman.
- Amputation of either lower limbs.
- Surgery of lower limb during the current admission.
- 4. 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.
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- Patients on Continuous Renal Replacement Therapy.
- Sepsis with poor prognosis.
- Competing trial
- Moribund within 48hours.
- COVID-19 patients.
- Declined to participate the study
Trial locations and contacts
1 site in 1 country.
Lian Ting Wong contact
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Geetha Kayambu, geetha_kayambu@nuhs.edu.sg
Lian Ting Wong, lian_ting_wong@nuhs.edu.sg
About this study
Official title: Attenuation of Sarcopenia Using Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients: A Pilot Randomized Controlled Trial (PIVOT)
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.
Read more
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.
Read the detailed 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.
- Conditions
- Nutritional Deficiency, Cachexia
- Being tested
- Optimal protein supplementation to achieve 80% protein adequacy.
- Medical subject headings
- Malnutrition, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal protein supplementation to achieve 80% protein adequacy.Dietary supplement
Additional protein required and delivered by adding protein powder and given in bolus feeds
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Optimal protein supplementation to achieve 80% protein adequacy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Day 1 of Randomisation; Day 4 of Randomisation
Indirect calorimetry (IC)
Gold standard for measurement of energy expenditure (EE)
Measured: Day 1 to Day 7 of Randomisation (daily or till extubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start6 Sep 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional DeficiencyStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Geetha Kayambu, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603585
- Sponsor's protocol ID
- 2021/00201
- Status last verified
- Nov 2022
- First submitted
- 19 Sep 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attenuation of Sarcopenia Using Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients: A Pilot Randomized Controlled Trial (PIVOT)
- ClinicalTrials.gov ID
- NCT05603585
- Acronym / sponsor ID
- 2021/00201
- Conditions
- Nutritional Deficiency, Cachexia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Standard care as per current ICU feeding regime. |
| Interventional Group | Experimental | Dietary Supplement: Optimal protein supplementation to achieve 80% protein adequacy.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. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 21 years and above.
- Expected mechanical ventilation duration ≥ 48 hours.
- Expected to stay in hospital for ≥ 4 days.
Key exclusion criteria (12 listed)
- Pregnant woman.
- Amputation of either lower limbs.
- Surgery of lower limb during the current admission.
- 4. Any neurological/rheumatologic/orthopaedic/burn/trauma/physiological problem with feeding difficulties during 48h of intubation
- Wheelchair-bound, walking aids and ADL-dependent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimal protein supplementation to achieve 80% protein adequacy.Additional protein required and delivered by adding protein powder and given in bolus feeds | Dietary supplement | Interventional Group |
Primary outcome
Functional Status Score for ICU (FSS-ICU)
Time frame: Day 1 of Randomisation; Day 7 of Randomisation; Day of ICU Discharge , approximately 14 days after ICU admission
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.
5 secondary outcomes
Rectus Femoris Cross-Sectional Area (RFCSA) and anterior thigh and rectus femoris thickness
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)
Time frame: 3 months post hospital discharge
Clinical Frailty Index (CFI)
Time frame: Day 1 of Randomisation; Day of ICU Discharge , approximately 14 days after ICU admission
Blood Biomarkers
Time frame: Day 1 of Randomisation; Day 4 of Randomisation
Indirect calorimetry (IC)
Time frame: Day 1 to Day 7 of Randomisation (daily or till extubation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lian Ting Wong contact
Geetha Kayambu principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal protein supplementation to achieve 80% protein adequacy. in people with Nutritional Deficiency and Cachexia, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geetha Kayambu (6779 5555, geetha_kayambu@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Status Score for ICU (FSS-ICU) (time frame: Day 1 of Randomisation; Day 7 of Randomisation; Day of ICU Discharge , approximately 14 days after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.