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NCT05603585
Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients
NA trial testing Optimal protein supplementation to achieve 80% protein adequacy. in Nutritional Deficiency in 150 participants. Status unknown.
30 September 2023
Quick facts
| Lead sponsor | National University Hospital, Singapore |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 150 |
| Start date | 6 September 2022 |
| Primary completion | 30 September 2023 |
| Estimated completion | 30 September 2023 |
| Sites | 1 location across Singapore |
Drugs / interventions tested
- Optimal protein supplementation to achieve 80% protein adequacy.
Conditions studied
- Nutritional Deficiency — all drugs for Nutritional Deficiency →
- Cachexia — all drugs for Cachexia →
Sponsor
National University Hospital, Singapore
Who can join
Adults 21 to 99, any sex, with Nutritional Deficiency or Cachexia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05603585
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05603585 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National University Hospital, Singapore
- Last refreshed: 1 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05603585.
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