The Effect of a 6-month Dietitian-tailored Nutrition Intervention to Patients With Critical Illness (DETAIL)

NCT07149246 | Recruiting

• 2 other identifiers: 2025/882796 (REK)HNF1745-25
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This research project aims to study the effect of optimal and individualised nutrition to patients with critical illness during the intensive care unit (ICU) and hospital admission, and until six months after admission. The investigators want to describe and compare the usual care with a dietitian-tailored nutrition care. The hypothesis is that dietitian-tailored nutrition care will result in a higher mean energy intake compared to usual care.

Conditions

ICU Patients; Nutrition Intake; Critical Illness

Keywords

Nutrition; Energy intake; Protein intake; ICU; Dietitian

Outcome Measures

Primary Outcomes (1)

• Mean energy intake

  Mean energy intake from day 10 to the end of follow-up of 6 months.

  Up to 6 months

Secondary Outcomes (14)

• Protein intake

  Up to 6 months

• Nutrition intake

  Day 10, day 30, day 90 and day 180

• Nutrition risk during overall follow-up

  Baseline, day 10, day 30, day 90 and day 180

• Nutrition risk during ICU admission

  ICU admission up to 6 months

• Health related quality of life

  Day 10, day 30, day 90 and day 180

Other Outcomes (7)

• ICU stay

  Up to 6 months

• Hospital stay

  Up to 6 months

• Mortality

  Up to 6 months

Study Arms (2)

Standard care

NO INTERVENTION

Nutrition intervention

EXPERIMENTAL

A 6-month Dietitian-tailored nutrition intervention

Other: Nutrition intervention

Interventions

Nutrition intervention OTHER

Frequent follow-up from a dietitian during ICU and hospital stay, and after discharge, up to 6 months after ICU admission.

Nutrition intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to the intensive care unit for \>48 hours.
• At least 18 years of age
• 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
• Permanent living address in Norway

You may not qualify if:

• 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
• Dialysis dependent chronic renal failure
• Suspected or known pregnancy
• Wheelchair user
• Cognitive impairment in which intervention is considered not appropriate
• Eating disorders -

Sponsors & Collaborators

• University Hospital of North Norway: lead
• The Northern Norway Health Authority: collaborator
• Karolinska University Hospital: collaborator

Study Sites (1)

University Hospital of North Norway

Tromsø, 9037, Norway

RECRUITING

MeSH Terms

Conditions

Critical Illness

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Anders Benjamin Kildal, MD, PHD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders Benjamin Kildal, MD, PHD

CONTACT

+47 77798928; anders.benjamin.kildal@unn.no

Tuva Hjetland Løland, MSNC

CONTACT

+4777626385; tuva.hjetland.loland@unn.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant in Anesthesiology and Intensive Care

Model Details: 2 arms

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 29, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)