6-month dietitian-guided nutrition program for patients recovering from critical illness

The Effect of a 6-month DiEtitian-TAILored Nutrition Intervention Compared to Usual Care in Patients With Critical Illness. A Single Center Prospective Intervention Study

This project will try giving ICU patients individualized nutrition care from a clinical dietitian during their hospital stay and for six months after to see if they consume more calories and protein than with usual care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital of North Norway (other)
• Locations: 1 site (Tromsø)
• Trial ID: NCT07149246 on ClinicalTrials.gov

What this trial studies

This interventional study will enroll adults admitted to the ICU for more than 48 hours with one or more organ failures. Participants are assigned to either standard local nutrition care or to a dietitian-tailored program with frequent follow-up from inclusion through six months after admission. The dietitian group receives individualized nutrition prescriptions during hospitalization and scheduled consultations after discharge, with energy and protein intake and other outcomes collected at days 10, 30, 90, and 180. Physical performance tests and blood sampling are optional, and follow-up data are collected regardless of discharge location.

Who should consider this trial

Good fit: Adults (≥18) admitted to the ICU for >48 hours with at least one organ failure who can give informed consent and have a permanent address in Norway are ideal candidates.

Not a fit: Patients with imminent death within 96 hours, those unable to consent, or people without a permanent Norwegian address or reliable follow-up are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, individualized dietitian-led care could increase calorie and protein intake during and after ICU stays and may improve recovery and physical function.

How similar studies have performed: Previous dietitian-led nutrition programs have sometimes increased energy and protein intake in ICU patients, but evidence for clear long-term functional benefits is mixed.

Eligibility criteria

Inclusion Criteria: Patients in intensive care who gives an informed consent and meet all of the following will be eligible:

1. Admitted to the intensive care unit for \>48 hours.
2. At least 18 years of age
3. Have one or more organ system failure (respiratory,cardiovascular or renal) related to their acute illness defined as:

   a. PaO2/FiO2≤300 mm Hg) b. Currently on one or more continuous inotrope/vasopressor infusion which were started at least 4 hours ago at a minimum dose of: i. Norepinephrine≥0.1 mcg/kg/min ii. Epinephrine≥0.1 mcg/kg/min iii. Any dose of vasopressin iv. Milrinone\>0.1 mcg/kg/min) c. Renal dysfunction defined as: i. Serum creatinine 2.0-2.9 times baseline or ii. Urine output 0.5 mL/kg/hour for ≥12 hours or iii. Currently receiving renal replacement therapy) d. Currently has an intracranial pressure monitor or ventricular drain in situ
4. Permanent living address in Norway

Exclusion Criteria: Patients will be excluded if:

1. Death is imminent in the next 96 hours or there is a current treatment limitation in place or the patient is unlikely to survive to 180 days due to underlying/chronic illness
2. Dialysis dependent chronic renal failure
3. Suspected or known pregnancy
4. Wheelchair user
5. Cognitive impairment in which intervention is considered not appropriate
6. Eating disorders -

Where this trial is running

Tromsø

• University Hospital of North Norway — Tromsø, Norway (RECRUITING)

Study contacts

• Principal investigator: Anders Benjamin Kildal, MD, PHD — University Hospital of North Norway
• Study coordinator: Anders Benjamin Kildal, MD, PHD

Conditions: ICU Patients, Nutrition Intake, Critical Illness, Nutrition, Energy intake, Protein intake, ICU, Dietitian