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Higher protein intake after intensive care

Higher versus standard protein targets in post-intensive care unit patients: a randomised, unblinded parallell group feasibility trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14011923
Enrollment
50
Registered
2026-05-22
Start date
2026-05-25
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

The effect of post-intensive care unit nutrition support on recovery after critical illness. Nutritional, Metabolic, Endocrine

Interventions

Patients expected to be discharged from ICU within 72 hours are screened for inclusion. After obtaining informed consent, study subjects are randomised to one of the two treatment arms: - Interventi

Sponsors

Karolinska University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. 18 years or older 2. ICU length of stay >72 hours 3. Received invasive mechanical ventilation for 48 hours or more 4. Received enteral or parenteral nutrition during ICU stay 5. Discharged or expected to be discharged alive from ICU within 72 hours of enrollment

Exclusion criteria

Exclusion criteria: 1. Inability to provide informed consent 2. > 72 hours between ICU discharge and enrollment 3. Inherited or acquired disorders of amino acid metabolism where high protein intake is contraindicated 4. Central nervous system injury (prior to or during hospitalisation) with impaired lower limb motor function expected to interfere with outcome assessment 5. Pre-existing cognitive impairment or language barrier expected to prevent outcome assessment or informed consent 6. Primary neuromuscular disease (e.g. myasthenia gravis, Guillanne Barré, multiple sclerosis with impaired lower limb motor function) 7. Severe lower limb arterial insufficiency expected to prevent outcome assessment 8. Lower extremity impairments (e.g. amputation, fractures, arthritis) preventing outcome assessment 9. Morbid obesity where subcutaneous adipose tissue prevents visualisation on muscle ultrasound 10. Expected dealth during hospitalisation or limitations in treatment to best supportive care 11. CAM-ICU positive on screening (patient can be screened again if delirium resolves) 12. Milk protein allergy 13. Unable to walk independently prior to acute illness resulting in ICU admission (walking aid permitted) 14. Renal insufficiency with eGFR < 45ml/min/1.73m2 15. Decompensated cirrhosis with hepatic encephalopathy 16. Treating physician at receiving ward does not consider randomisation to treatment targets to be in the best interest of the patient 17. Acute or chronic macronutrient malabsorption (i.e. high output ileostomy, intestinal failure) where the physician responsible for the patient's short or long-term care does not consider randomisation to treatment targets to be in the best interest of the patient 18. Pregnancy

Countries

Sweden

Contacts

Public ContactRebecca Lindström
rebecca.j.lindstrom@regionstockholm.se+46 08-12380000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026