University Hospital of North Norway
Tromsø, 9037, Norway
Location status: Recruiting
NCT Number: NCT07149246
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Tromsø, 9037, Norway
Location status: Recruiting
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.
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:
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
Exclusion criteria
Patients will be excluded if:
Frequent follow-up from a dietitian during ICU and hospital stay, and after discharge, up to 6 months after ICU admission.
Time frame: Up to 6 months
Mean energy intake from day 10 to the end of follow-up of 6 months.
Time frame: Up to 6 months
Mean protein intake from day 10 to the end of follow-up of 6 months.
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
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.
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.
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.
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).
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).
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.
Time frame: Baseline, day 10, day 30, day 90 and day 180
Weight, Changes in weight between measurement points
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)
Time frame: Day 10, day 30, day 90 and day 180
Changes in hand grip strength assessed with a hand dynamometer
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).
Time frame: Baseline, day 10, day 30, day 90 and day 180
Changes in muscle mass assessed with ultrasound
Time frame: Day 10, day 30, day 90 and day 180
Changes in resting energy expenditure measured with indirect calorimetry
Time frame: Up to 6 months
Duration of intensive care unit (ICU) stay in survivors and non-survivors
Time frame: Up to 6 months
Duration of hospital stay in survivors and non-survivors
Time frame: Up to 6 months
Intensive care unit (ICU), in hospital and 30-day, 90-day and 6 months mortality
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
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.
Time frame: 6 months
Cost per quality-adjusted life year (QALY)
Time frame: 6 months
Cost per life-year gained (LYG)
Contact information is provided by the study sponsor or research team.
Anders Benjamin Kildal, MD, PHD
CONTACT
Tuva Hjetland Løland, MSNC
CONTACT
University Hospital of North Norway
Other
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
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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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