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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital of North Norway

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Admitted to the intensive care unit for >48 hours.

At least 18 years of age

Permanent living address in Norway

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Nutrition intervention

    Other intervention

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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Standard careNo intervention 0 interventions
Group B: Nutrition interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean energy intake

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

Time frame
Up to 6 months

Secondary outcomes

1

Protein intake

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

Time frame
Up to 6 months
2

Nutrition intake

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

Time frame
Day 10, day 30, day 90 and day 180
3

Nutrition risk during overall follow-up

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.

Time frame
Baseline, day 10, day 30, day 90 and day 180
4

Nutrition risk during ICU admission

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.

Time frame
ICU admission up to 6 months

Other outcomes

1

ICU stay

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

Time frame
Up to 6 months
2

Hospital stay

Duration of hospital stay in survivors and non-survivors

Time frame
Up to 6 months
3

Mortality

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

Time frame
Up to 6 months
4

Effect of energy intake above 20 kcal/kg/dag

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital of North Norway

Lead sponsor

The Northern Norway Health Authority

Collaborator

Karolinska University Hospital

Collaborator