Higher protein intake after intensive care
| ISRCTN | ISRCTN14011923 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14011923 |
| Sponsor | Karolinska University Hospital |
| Funders | Dr Per Håkanssons stiftelse, Stockholms Läns Landsting |
- Submission date
- 27/03/2026
- Registration date
- 22/05/2026
- Last edited
- 22/05/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Critically ill patients experience severe and rapid muscle loss during intensive care unit (ICU) stay. The optimal nutrition support strategy after ICU discharge to support recovery of physical function is unknown. This study aims to investigate the effect of higher protein intake on muscle mass and physical function after intensive care.
Who can participate?
Patients admitted to the study center's ICU who remain in the ICU for at least 3 days, and receive invasive mechanical ventilation for 2 days. Study participants are enrolled on ICU discharge.
What does the study involve?
Participants are randomized to a protein target of either 2.0 grams/kg/day or 1.2 grams/kg/day, with similar energy targets. During hospital stay, an ICU dietitian will review the patient's nutrition 2-3 times per week and support the ward in achieving the allocated protein target. After hospital discharge, participants in both groups will receive telephone counseling by the study dietitian every 1-2 weeks. Participants in the high protein group also get home deliveries of high protein supplements to augument protein intake. Around 90 days after ICU discharge, participants are followed up with an assessment of muscle mass, physical function tests and self-rated health.
What are the possible benefits and risks of participating?
Participants in both trial arms will receive frequent dietitian counseling which is expected to result in better overall adherence to energy and protein targets compared to standard care. Similar strategies have been demonstrated to improve morbidity and survival in non-critically ill, hospitalized patients. Potential risks involve adverse medical effects of a higher-than-normal protein intake, which may be harmful for renal functions in some circumstances. To minimize this risk, patients with moderate-severe renal impairment are excluded from study participation.
Where is the study run from?
The study sponsor is Region Stockholm (Stockholm County Council, a government body in Sweden). The study will be performed at Karolinska University Hospital Huddinge, in Stockholm Sweden.
When is the study starting and how long is it expected to run for?
May 2026 to June 2027.
Who is funding the study?
The study is funded by an unrestricted grant from Dr. P Håkansson's Stiftelse. The primary investigator's research time is also funded by a salary grant from Region Stockholm.
Who is the main contact?
The main contact for the study is the primary investigator, Martin Sundström Rehal, martin.sundstrom-rehal@regionstockholm.se
Contact information
Public
ME Klinisk Nutrition, Karolinska University Hospital Huddinge, Hälsovägen 13
Stockholm
14186
Sweden
| Phone | +46 08-12380000 |
|---|---|
| rebecca.j.lindstrom@regionstockholm.se |
Scientific, Principal investigator
Funktion PMI, K32, Karolinska University Hospital Huddinge, Hälsovägen 13
Stockholm
14186
Sweden
| Phone | +46 08-12380000 |
|---|---|
| martin.sundstrom-rehal@regionstockholm.se |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Dose comparison |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Higher versus standard protein targets in post-intensive care unit patients: a randomised, unblinded parallell group feasibility trial |
| Study acronym | HiPPIe |
| Study objectives | The main study objective is to determine the feasibility of a randomized controlled trial investigating a high versus standard protein target for up to 90 days after ICU discharge. Secondary objectives include documenting the effects of a higher versus standard protein target after ICU discharge on physical function, nutritional status and other patient-centered outcome measures. |
| Ethics approval(s) |
Approved 27/10/2025, Swedish Ethical Review Authority (Etikprövningsmyndigheten Box 2110, Uppsala, 750 02, Sweden; +46 010-475 08 00; registrator@etikprovning.se), ref: 2025-05679-01 |
| Health condition(s) or problem(s) studied | The effect of post-intensive care unit nutrition support on recovery after critical illness. |
| Intervention | 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: - Intervention: Daily protein target of 2.0 g/kg for up to 90 days after ICU discharge. - Control: Daily protein target of 1.2 g/kg for up to 90 days after ICU discharge. The trial assignment is open label. Guidelines for energy targets are equivalent between groups. All participants will be assessed by a study dietitian to determine the optimal route and composition of feeding to achieve nutritional targets. Within 72 hours from ICU discharge, body composition will be determined by weight (kg), an ultrasonographic measurement of quadriceps muscle layer thickness (cm) and bioimpedance analysis. Medical Research Council Sum Score and grip strength by hand dynamometry will also be tested at baseline. During hospitalization, nutritional intake (oral, enteral and parenteral) will be documented daily and reviewed by the study dietitian two to three times weekly to determine the adequacy of current feeding strategies, with revised recommendations as appropriate. Biochemical markers of inflammation and renal function will be monitored at a frequency consistent with usual care on the admitting ward and documented in the eCRF. After hospital discharge, participants will receive telephone consultations with the study dietitian every 1-2 weeks to review the adequacy of protein and energy intake. Participants in the high-protein group will also receive home deliveries of high protein oral nutrition supplements corresponding to a daily intake of 0.8 g/kg. A more extensive review of home intake is performed 2-3 times during outpatient follow-up with a 3-day food diary. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/06/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 25/05/2026 |
| Date of final enrolment | 30/06/2027 |
Locations
Countries of recruitment
- Sweden
Study participating centre
-
-
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
08/04/2026: Study's existence confirmed by the Swedish Ethical Review Authority.
