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Recruiting NCT05603585

Optimal Protein Supplementation and Early Exercise In Mechanically Ventilated Patients

Conditions: Nutritional Deficiency, Cachexia

Sex: All
Ages: 21 Years – 99 Years
Phase: NA
Enrollment: 150
Sponsor: National University Hospital, Singapore

Location: Singapore

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.

Eligibility Criteria

Inclusion Criteria:Age 21 years and above.Expected mechanical ventilation duration ≥ 72hours (to allow for inclusion of those with ICU stay of at least 3 days as increased MV dependence might increase global weakness).Expected to stay in hospital for ≥ 7days (to allow for inclusion of those with bedrest of more than 7 days as would increase the likelihood of muscle loss).Exclusion Criteria:Pregnant woman.Amputation of either lower limbs.Surgery of lower limb during the current admission.Any neurological/rheumatologic/orthopaedic/burn problem that may impact or confound rehabilitation.Patient not able to feed by 48 hours AND not given parenteral feeding.Patients on Continuous Renal Replacement Therapy.Sepsis with poor prognosis.Moribund within 48hours.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05603585). StuddyBuddy aggregates publicly available trial information.