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The impact of combined ß-Hydroxy-ß-methylbutyrate (HMB) and protein supplement on physical function in post-discharge ICU survivors: a pragmatic, randomized controlled trial (The ABLE trial)

The impact of combined ß-Hydroxy-ß-methylbutyrate (HMB) and protein supplement on physical function in post-discharge ICU survivors: a pragmatic, randomized controlled trial (The ABLE trial)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080867
Enrollment
Unknown
Registered
2024-02-09
Start date
2024-02-15
Completion date
Unknown
Last updated
2024-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical illness

Interventions

Experimental group:Receive an additional daily 3 g of HMB + 60 g of protein supplementation for 90 days
Control group:No additional nutritional support is provided

Sponsors

Jinling Hospital Affiliated to Nanjing University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Obtain informed consent 2. Age = 18 years old 3. It is expected to be out of the ICU within 24 hours 4. Mechanical ventilation for at least 48 hours during the ICU stay 5. Have been admitted to ICU for at least 8 days, but not more than 28 days

Exclusion criteria

Exclusion criteria: 1. Patients who are expected to die or stop life support treatment within 48 hours after being discharged from the ICU 2. Patients who are expected to need to be readmitted to the ICU within 1 week after being discharged from the ICU 3. Severe liver failure (Child-Pugh grade C) at the time of discharge from the ICU 4. Chronic kidney disease (creatinine clearance rate< 40mL/min) 5. Patients who are pregnant or breastfeeding 6. Unable to walk independently before admission to the ICU (if you can walk independently with a walking aid, you can be included) 7. There are contraindications to the use of protein supplements or HMB products (e.g., severe renal insufficiency requiring regular hemodialysis, allergy to whey protein, etc.) 8. Patients with known cognitive dysfunction, lower limb injury, systemic neuromuscular disease, and cranial or spinal problems and other problems that affect the evaluation of study results

Design outcomes

Primary

MeasureTime frame
6 minutes walking distance ;

Secondary

MeasureTime frame
blood urea nitrogen;Serum creatinine;Prealbumin;Albumin;C-reaction protein;lymphocyte;Mortality;Proportion of ICU readmission;Days of non-hospitalization and survival;Readmission hospital rate;gait reconstruction data analysis;Hand grip strength measurement;Barthel Index;Clinical Frailty Scale;Nutritional support;Subjective globe assessment;EuroQol five dimensions five-level questionnaire;Body composition analysis;

Countries

China

Contacts

Public ContactLi Weiqin

Jinling Hospital Affiliated to Nanjing University School of Medicine

ctgchina@medbit.cn+86 139 5183 9654

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026