Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059233) titled 'High-protein nutrition in ICU patients undergoing advanced early mobilization' on Sept. 29.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - Other
Condition:
Condition - ICU patients
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This trial aims to investigate whether combining high-protein nutrition with early mobilization can promote physical and functional recovery.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - In the control group, nutritional administration is targeted at the lower limit of the protein level (1.2 g/kg/day) indicated in each guideline. The intervention group will be fed at 1.8 g/kg/day of protein.
Interventions/Control_2 - In the control group, nutritional administration is targeted at the lower limit of the protein level (1.2 g/kg/day) indicated in each guideline. The intervention group will be fed at 1.8 g/kg/day of protein.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Inclusion criteria were (1) general or emergency (ICU) inpatients aged 18 years or older, (2) independent of ADLs prior to admission, and (3) patients expected to remain on a ventilator for at least 48 hours.
Key exclusion criteria - Exclusion criteria are (1) scheduled surgical patients, (2) patients weighing 200 kg or more (due to device weight capacity of up to 200 kg), (3) patients admitted for neuromuscular disease, (4) patients with leg loss or load limitation due to post-hospitalization surgery, (5) patients transferred after 48 hours of ventilation, (6) patients for whom enteral nutrition is impossible; and (7) patients expected to die within 7 days.
Target Size - 90
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 10 Day
Date of IRB - 2025 Year 09 Month 05 Day
Anticipated trial start date - 2025 Year 09 Month 30 Day
Last follow-up date - 2027 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067751
Disclaimer: Curated by HT Syndication.