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NCT Number: NCT07149246

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of North Norway

Tromsø, 9037, Norway

Location status: Recruiting

Location contact

Anders Benjamin Kildal, MD, PHD

CONTACT

[email protected]

+47 77798928

About this study

The study will recruit patients with critical illness in one of two groups. Group one will receive standard nutrition care following the current local guidelines. Group two will receive frequent follow-up by a clinical dietitian from inclusion and until six months from admission. The dietitian will be responsible for the nutrition administered to the patient during hospital admission and will have consultations with the patients after discharge. The patients in group two will receive individualized nutrition care and recommendations.

In addition to outcome measures regarding nutrition, the patients can choose if they want to perform physical tests and blood tests as well, but that part of the study is optional. In both groups, outcome measures will be collected at day ten, 30, 90 and 180 days after admission to the ICU. The collection of data will occur even though the patients have been discharged from the hospital, either to their home or another health care facility.

The aim is to study the effect of optimal and individualised nutrition to patients with critical illness during the ICU and hospital admission, and until six months after admission. Firstly, the investigators want to describe the usual care and progression of the patients during the first six months after hospital admission. Secondly, the investigators want to see if frequent follow-up by a clinical dietitian can increase nutritional intake during the same period.

The hypothesis is that dietitian-tailored nutrition care will result in a higher mean energy intake compared to usual care, and that this will further impact other aspects, such as quality of life and physical function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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

Exclusion criteria

Patients will be excluded 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 -

Treatment and study plan

Nutrition Intervention

Other

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

Primary outcomes

  1. Mean energy intake

    Time frame: Up to 6 months

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

Secondary outcomes

  1. Protein intake

    Time frame: Up to 6 months

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

  2. Nutrition intake

    Time frame: Day 10, day 30, day 90 and day 180

    Energy and protein intake on each measurement point, Energy and protein intake by location (intensive care unit and ward), Energy and protein intake delivered by nutrition therapy

  3. Nutrition risk during overall follow-up

    Time frame: Baseline, day 10, day 30, day 90 and day 180

    Assessed with Nutrition Risk Screening 2002 (NRS-2002) at all measure time points, where the score 0-2 indicate no nutrition risk, and a score > 3 indicate nutrition risk.

  4. Nutrition risk during ICU admission

    Time frame: ICU admission up to 6 months

    Assessed with the modified Nutrition Risk in Critically Ill (mNUTRIC) score, ranging from a minimum value of 0 and a maximum value of 9. 0-4 points indicate a low malnutrition risk, 5-9 points indicate patients at high nutrition risk which are the most likely to benefit from aggressive nutrition therapy.

  5. Health related quality of life

    Time frame: Day 10, day 30, day 90 and day 180

    Assessed using the European Quality Of Life 5 Dimensions (EQ-5D) descriptive system. Each dimension has 5 levels ranging from no problems (1) to extreme problems (5), there is no overall score.

  6. Self-rated health state

    Time frame: Day 10, day 30, day 90 and day 180

    Self-rated by the participants using the European Quality Of Life Visual Analogue Scale (EQ-VAS). The VAS ranges from "The worst health you can imagine" (0) to "The best health you can imagine" (100).

  7. Frailty

    Time frame: Baseline, day 10, day 30, day 90 and day 180

    Assessed with clinical frailty scale (CFS), which is an ordinal scale with nine steps from very fit (1) to terminally ill (9).

  8. Mobility

    Time frame: ICU admission up to 6 months

    Assessed during intensive care unit (ICU) admission using the 11-category ICU Mobility Scale, with 10 as the maximum value, where 0 indicate no activity and 10 indicate independent walking.

  9. Weight

    Time frame: Baseline, day 10, day 30, day 90 and day 180

    Weight, Changes in weight between measurement points

  10. Physical performance

    Time frame: Day 10, day 30, day 90 and day 180

    Changes in physical performance will be assessed using the Short Physical Performance Battery (SPPB). It consists of three tests; gait speed, balance test and a sit-to-stand test. The scores of the three tests are summarized, and the total score is ranging from 0 points to a maximum of 12 points. The score is divided in three levels of performance: low (0-6 points), medium (7-9 points), and high (10-12 points)

  11. Hand grip strength

    Time frame: Day 10, day 30, day 90 and day 180

    Changes in hand grip strength assessed with a hand dynamometer

  12. Body composition

    Time frame: Day 10, day 30, day 90 and day 180

    Changes in fat-free mass and lean mass assessed with bioelectrical impedance analysis (BIA).

  13. Muscle mass

    Time frame: Baseline, day 10, day 30, day 90 and day 180

    Changes in muscle mass assessed with ultrasound

  14. Resting energy expenditure

    Time frame: Day 10, day 30, day 90 and day 180

    Changes in resting energy expenditure measured with indirect calorimetry

Other outcomes

  1. ICU stay

    Time frame: Up to 6 months

    Duration of intensive care unit (ICU) stay in survivors and non-survivors

  2. Hospital stay

    Time frame: Up to 6 months

    Duration of hospital stay in survivors and non-survivors

  3. Mortality

    Time frame: Up to 6 months

    Intensive care unit (ICU), in hospital and 30-day, 90-day and 6 months mortality

  4. Effect of energy intake above 20 kcal/kg/dag

    Time frame: Day 10, day 30, day 90 and day 180

    Independent of group allocation, an analysis regarding all secondary outcome measures will be performed comparing participants with an energy intake of >20 kcal/kg/day with participants with <20 kcal/kg/day

  5. Effect of energy intake above 25 kcal/kg/day

    Time frame: Day 10, day 30, day 90 and day 180

    Independent of group allocation, two analysis regarding all secondary outcome measures will be performed comparing participants with an energy intake of >25 kcal/kg/day with participants with <25 kcal/kg/day.

  6. Cost per quality-adjusted life year

    Time frame: 6 months

    Cost per quality-adjusted life year (QALY)

  7. Cost per life-year gained

    Time frame: 6 months

    Cost per life-year gained (LYG)

Study contacts

Contact information is provided by the study sponsor or research team.

Anders Benjamin Kildal, MD, PHD

CONTACT

[email protected]

+47 77798928

Tuva Hjetland Løland, MSNC

CONTACT

[email protected]

+4777626385

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Karolinska University Hospital
  • The Northern Norway Health Authority

Registry information

Official study title

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

Acronym: DETAIL

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 29, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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