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
Phase: NA
Conditions: ICU Patients, Nutrition Intake, Critical Illness
Sponsor: University Hospital of North Norway

​
 
The effect of a 6 month DiEtitian-TAILored nutrition intervention 
compared to usual care in patients with critical illness (DETAIL): a single 
center prospective intervention study.  
 
Study protocol.  
 
Project manager: Anders Benjamin Kildal. 
 
1.0 Background 
Malnutrition is common both in the ICU and the hospital in general (1,2). Thus, 
sufficient nutrition is of great importance to ICU patients, both during ICU stay, but also in 
the wards and after hospital discharge. Several clinical practice guidelines (3,4) have been 
published summarizing evidence from more than hundreds of randomized controlled trials 
(RCTs) to provide evidence-based guidelines regarding nutrition in the ICU.  
However, nutritional research in the ICU has mainly focused on the early, acute period 
of critical illness. Recently, the focus has somewhat shifted to the post-ICU hospitalization 
period. However, the literature on post-ICU nutrition is still scarce (5). As in the ICU, 
competing work priorities is an important consideration, as nutritional therapy is prioritized 
less than other nursing tasks in the wards (6,7). In one of the few studies following the patient 
throughout the hospitalization from ICU to post-ICU ward, the ICU patient does not receive 
the energy and protein delivery recommended in guidelines and this persists after ICU 
discharge (6). Another study of post-ICU patients also found that the energy and protein 
intake was less than the measured energy expenditure and estimated requirements (7). 
Adequacy of nutritional intake in the post-ICU hospitalization period is highly dependent on 
the route of feeding, whereas patients with an oral intake have the poorest energy and protein 
intake (despite food fortification strategies and/or oral nutritional supplements) (8). 
In Europe, we use the guidelines from the European Society of Clinical Nutrition and 
Metabolism (ESPEN) (9). A large systematic scoping review from 2019 found that adherence 
to these guidelines can improve clinical outcomes and quality of life, as well as reduce ICU 
and hospital length of stay and healthcare costs (10). ESPEN guideline on clinical nutrition in 
the intensive care unit state that energy needs could be calculated by using simple 
weight-based equations such as 20-25 kcal/kg/day. A recommendation of <70% (i.e. 
hypocaloric nutrition) of the estimated energy is preferred during the first week of ICU 
admission, with an increase to 80-100% (isocaloric nutrition) from the second week.  
Furthermore, ESPEN recommends that during critical illness, 1.3 g protein/kg/day can be 
delivered progressively (4). However, there is a lack of more specific weekly energy 
recommendations after the first week and during recovery post-ICU. For reference, 
recommendations for the general hospitalized patient are 30 kcal/kg/day and at least 1.2 
g/kg/day (11).  
A recently published cohort study investigated the protein and energy 
intake during the first week of hospital stay and the first year of recovery amongst ICU 
survivors (12). After 12 months, only 10% of 60 patients achieved the advised 1.2 g/kg/day 
protein target, whereas 28% reached the advised 25 kcal/kg/day energy target. Interestingly, 
during recovery, the proportion of patients using supplementation to increase energy and/or 
protein intake was only 15% at 3 months, 12% at 6 months, and 10% at 12 months. Overall, 
patients using dietary supplements had a higher protein intake at 3, 6, and 12 months and a 
higher energy intake after 3 months.  
​
     Apart from this study, no studies have collected information regarding nutritional 
intake in the ICU recovery phase. Additionally, no interventional studies with the purpose of 
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improving nutritional intake up to six months post-ICU admission have been performed. 
However, some studies have been done in other patient populations. A systematic review and 
meta analysis from 2022, including a total of 14 RCTs and 2438 discharged medical patients, 
found that nutrition support, including both oral nutrition supplements and frequent dietetic 
follow up, after hospital discharge increased daily energy and protein intake. It also increased 
body weight, and most importantly, improved survival compared to no follow-up. No 
differences were found in regards to readmissions and physical outcome (13). Additionally, 
the EFFORT II study, a large multicenter RCT is now planned to be conducted investigating 
the effect of continued nutritional therapy with dietetic follow-ups after hospital discharge in 
ward patients (14). 
The aforementioned meta-analysis concluded that nutrition support to medical patients 
after hospital discharge can increase the patient's nutritional intake. However, in ICU patients, 
the effect of interventions to achieve nutritional targets in the recovery phase remains unclear. 
This study aims to address this evidence gap by determining if a standardized dietetic 
consultation during a six month period from ICU admission will result in an increased energy 
intake compared to no planned dietetic consultations.  
 
2.0 Aim and outcomes 
This study will document standard nutritional care of patients admitted to the ICU 
during the whole ICU and hospital stay, as well as their nutritional intake after discharge. 
Furthermore, providing frequent consultations with a registered clinical dietitian, the aim will 
be to improve nutritional intake during the same period. 
 
2.1 Primary outcome 
Mean energy intake in kcal/kg/day from day ten until six months (on four time points) 
after ICU-admission.  
 
2.2 Secondary outcomes 
●​ 10-day, 30-day, 90-day and 180-day outcomes: 
○​ Nutrition intake 
■​ Protein intake 
■​ The amount of oral nutrition supplements, enteral and parenteral 
nutrition used 
○​ Nutritional risk including changes in weight (assessed by mNUTRIC score in 
the ICU and NRS-2002 in the wards and post-hospital) 
○​ Symptoms affecting nutritional intake and self-assessment of physical activity 
(assessed by the PG-SGA Short form) 
○​ Health-related quality of life (assessed by the EuroQol EQ-5D-5L and EQ 
VAS) 
○​ Frailty (assessed by the Clinical Frailty Score) 
○​ Resting energy expenditure and respiratory quotient (assessed by indirect 
calorimetry)      
○​ Physical performance (assessed by the Short Physical Performance Battery and 
the hand grip strength test) 
○​ Muscle mass (assessed by ultrasound) 
○​ Body composition (assessed by bioelectrical impedance analysis) 
○​ Mobility  (assessed by ICU Mobility Scale) 
●​ Energy and protein intake by location (ICU, ward and post-hospital discharge) 
●​ Duration hospital stay (survivors and non-survivors) 
●​ 6 months survival 
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●​ Cost per quality-adjusted life year (QALY) 
●​ Cost per life year gained (LYG) 
 
Additional analysis independently of which group the patients were allocated to will be 
performed on outcomes based on dividing the patients' regards to mean energy intake in 
kcal/kg/day from day ten until six months (on four time points) after ICU admission.  
 
3.0 Methods 
3.1 Trial design, setting and population 
This study is a single-center prospective, unblinded interventional study and will 
include 300 critically ill patients from the general ICU at the University Hospital of North 
Norway in Tromsø. Recruitment will start in 2025 with tentative completion of recruitment 
expected in 2027. The study research team comprises dietitians, a research nurse, ICU nurse, 
intensivists and a gastric surgeon. 
 
3.2 Sample size 
Sample size calculation is based on earlier studies conducted in the same fashion with 
similar primary endpoint (15). Further, earlier studies in our own ICU confirm a comparable 
and acceptable confidence interval of 95% and coefficient of variation, in comparison to the 
referred study. This study calculated a necessary sample size of 120 patients in each group 
inflated with 20% to account for potential dropouts. Due to the slightly longer follow-up in 
our study, we calculate with 150 patients in each group to ensure a sufficient study size with 
up to 50% dropout assumed to be overestimated. With 300 subjects in total, this study has 
95% power (two-sided p-value of 0.05) to an assumed acceptable difference of 15% 
difference in estimated average daily energy intake considered at the study’s primary 
endpoint.   
 
3.3 Eligibility, recruitment and consent 
Patients aged ≥18 years who have been admitted to our ICU will be screened for 
eligibility. Absolute inclusion criteria is informed written consent. See detailed inclusion and 
exclusion criteria below.  
 
3.3.1 Inclusion criteria 
Patients in intensive care who 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 
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iii.​ Currently receiving renal replacement therapy)  
d.​ Currently has an intracranial pressure monitor or ventricular drain in situ 
e.​ Permanent living address in Norway 
 
3.3.2 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 
 
3.3.3 Screening and recruitment 
Patients will be screened for eligibility through patient journals during the first 48 hours of 
admission to the intensive care unit. Screening will be performed by selected project staff 
members. Apart from the project manager, the members performing the screening are not 
affiliated with the ICU, and a dispensation for confidentiality to screen patient journals is 
needed.  
 
We want to start data collection and the intervention in group 2 (described below) as soon 
after 48 hours of admission as possible, since optimal nutritional care in the early phase of 
critical illness may be of importance for the short- and long-term recovery. To achieve this, 
we want to screen the patients before 48 hours of admission. Since one inclusion criteria is an 
ICU stay of >48 hours, the estimated length of stay will be discussed with the treating 
physician. Eligible patients with an estimated stay of more than 48 hours will be given 
information orally and in written form within the first 48 hours after admission. Due to the 
plan of starting the data collection as soon as possible, the patients or next of kin get 24 hours 
to decide about participation. Information is given and consent obtained by one of two 
selected project members who are not involved in the patients’ treatment.  
 
If the patient itself is in a state in which an informed written consent is not possible to obtain, 
next of kin will be asked to consent on behalf of the patient. If the next of kin has given 
consent on behalf of the patient, the patient will be given information about the study and 
asked for a delayed consent as soon as possible. If delayed consent is not given by the patient, 
data collection will stop, and all data can be deleted if requested. The signed consent form of 
the next of kin will thus no longer be valid. If the patient dies without being able to give 
consent, the consent from the next of kin will stay valid. Both the patient and next of kin can 
withdraw from participation at any time.  
 
3.4 Study plan  
This study consists of one observational period followed by one interventional period 
with a non-randomized recruitment. The patients will be recruited to one specific group, either 
the observational group or the intervention group. Firstly, patients will be recruited to the 
observational group until 150 patients are recruited. Consecutively, patients will be recruited 
to the interventional group until another 150 patients are recruited. Follow-up time in both 
groups is six months from admission time, independent of ICU and hospital length of stay. 
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In the observational group we will collect data regarding the standard, usual nutritional 
care in the ICU, post-ICU in the wards, as well as post-ICU discharge. In the interventional 
group, the patients will receive dietitian-tailored nutritional treatment and guidance during 
ICU admission, in the wards and after discharge. We have chosen to not conduct an RCT due 
to the interest in collecting data regarding the standard care before implementing an 
intervention. A trial may increase the focus on the nutrition in standard care, giving a wrong 
impression of the actual standard care as of today.  
 
Group 1: Observational group receiving standard care. 
Group 2: Interventional group receiving dietitian-tailored nutrition. 
 
3.4.1 Study levels 
Independent of which group the participants are a part of, they can choose between 
three “levels” of participation (consent), whereas level A consists of registration of nutritional 
intake and assessments with screening tools and questionnaires, level B consists of physical 
tests and level C consists of blood tests. Level A is obligatory for participating in the study, 
while participation in levels B and C is voluntary. See detailed description of the included 
assessments and tests in each level in the “Data collection”-section. The participants can 
choose to participate in A, A+B, A+C or A+B+C.  
 
3.4.2 Standard care 
In the ICU at UNN Tromsø, a local nutrition protocol has been implemented prior to 
this study to ensure that nutritional intake is as recommended during the ICU admission. The 
protocol is developed according to ESPEN guidelines on Clinical nutrition in the intensive 
care unit (4), with the following recommendations on nutritional intake: 
 
Recommended energy intake/supply 
-​
The first week: a goal of 18 kcal/kg/day with the recommended daily increase: 
-​
First day: 10 kcal/kg/day 
-​
Second day: 14 kcal/kg/day 
-​
Third to seventh day: 18 kcal/kg/day 
-​
From the second week: ≥ 25 kcal/kg/day 
 
Recommended protein intake/supply: 
-​
1.3 g/kg/day with a progressively increase during the first three days in the ICU. 
 
No specific nutrition plan is drafted when the patients are transferred to the wards. 
Further nutritional needs or plans are estimated/decided by the treating health personnel in the 
specific ward. 
 
3.4.3 Intervention 
In group 2, the dietitian will make an individual nutrition plan at study inclusion and 
follow-up every 24-48 hours throughout the hospital stay. After hospital discharge, the 
patients will be followed by telephone/video consult every 2-4 weeks by the study dietitian. 
The aim is to achieve an energy intake of at least 25 kcal/kg/day and a protein intake of at 
least 1.3 g/kg/day during the follow-up period. 
 
3.5 Data collection 
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Data collection of all parameters will be performed on day ten, day 30, 3- and 6-month 
following ICU admission, independent of if the patient is still admitted in the ICU, has been 
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transferred to the ward or has been discharged. Patients transferred to other hospitals in the 
region will also be followed-up. Data collection will be performed in the same manner in both 
groups, regardless of location.  
At enrolment, demographic data and information regarding the ICU admission and 
treatment will be collected. Furthermore, information of the nutritional intake and any use of 
medical nutrition therapy (oral nutrition supplements, enteral and parenteral nutrition) during 
the whole hospital admission will be collected. A detailed list of data that will be collected is 
attached to this REK-application in the file “Worksheet”. 
During admission, data will be collected through the digital patient journal system 
DIPS Arena and the electronic medical chart MetaVision. Direct information from the treating 
health personnel and the patient will also occur if there is missing data in these systems and 
when the patient eats itself. After discharge, the patients will provide the information during 
consultations either in the outpatient clinic or by telephone/video. The hospital’s 
video-solution Whereby will be used for video interactions. 
Below follows a description of the methods used to collect data regarding the primary 
and secondary outcomes. The descriptions are separated in the three levels as described 
previously (level A, B and C). See Table 1 for an overview of the methods used and the 
estimated time used on each method.  
 
3.5.1 Registration of nutritional intake (level A) 
From ICU admission until hospital discharge, the daily amount of energy and protein 
provided from oral nutrition, oral nutrition supplements, enteral and parenteral nutrition, as 
well as non-nutritional calories from glucose and propofol will be collected. Repeated 24-hour 
recall interviews will be conducted to gather information regarding oral nutritional intake on 
each collection time point (day 10, day 30, 3 or 6 months). At least two separate interviews 
will be conducted within a time frame of one to three weeks depending on the collection time 
point. If the variance of energy intake is greater than 10% between the two interviews, a third 
interview will be performed.  
 
Estimated time on level A: 45-60 minutes on each measurement point. Patients can be 
followed both at the outpatient clinic or by video/telephone.  
 
Table 1 Overview of the methods that will be used in the study  
Level 
 
Data collection 
All 
locations/time 
points 
 
Admission/inclusi
on 
 
ICU 
only 
Estimated time use 
for the study 
participant 
(minutes) 
 
 
 
 
 
A 
24-hour recall 
x 
 
 
30 
mNUTRIC Score 
 
x 
x 
0 
NRS-2002 
x 
x 
 
2 
PG-SGA Short form 
x 
 
 
3 
ICU Mobility Scale 
x 
x 
 
0 
Clinical Frailty Scale 
x 
x 
 
0 
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Health-related Quality of 
Life (EQ-5D-5L) 
x 
 
 
5 
 
 
 
 
 
B 
Short Physical 
Performance Battery 
x 
 
 
15 
Hand grip strength test 
x 
 
 
5 
Indirect calorimetry 
x 
 
 
20 
Bioelectrical impedance 
analysis 
x 
 
 
5 
Ultrasound 
x 
x 
 
5 
C 
Blood tests 
x 
x 
 
15 
 
3.5.2 Screenings and questionnaires (level A) 
Screening tools and questionnaires will be used to assess the patient’s nutritional 
status, clinical frailty, mobility status and quality of life. Nutrition risk will be assessed with 
Nutrition Risk Screening-2002 (NRS-2002) in all patients. This tool assesses changes in 
weight, body mass index, sickness and energy intake (16). Weight will be measured at least 
one till two times during the hospital stay in addition to the four collection time points. At 
follow-up after discharge, the weight will be measured in the outpatient clinic, or at home by 
the patients themselves. Additionally, mNUTRIC score will be used at inclusion and if the 
patient is in the ICU at the data collection time points. Both are validated tools in the hospital 
setting, the latter one is specifically validated for critically ill patients (16,17). The mNUTRIC 
Score includes SOFA and APACHE II scores which are screening tools aiming to predict ICU 
mortality (18).  
The patient's mobility status will be assessed with the ICU Mobility Scale (19). Frailty 
will be assessed using the Clinical Frailty Scale, which is a validated tool to assess frailty 
based on factors such as physical activity and function. It is an ordinal scale with nine steps 
from very fit to terminally ill (20). Clinical frailty score pre-ICU admission will also be 
collected. A Norwegian translation of the validated questionnaire EQ-5D-5L (obtained by 
EuroQol), commonly used in the ICU patient group (21), will be used to assess health-related 
quality of life. The questionnaire consists of two parts; a screening of general health (physical 
and mental) and a VAS-scale to grade self-perceived health. 
 PG-SGA Short form will be used to assess the patient’s symptoms related to food 
intake, as well as their physical activity level (22).  
 
3.5.3 Physical measurements (level B) 
            Measurement of resting energy expenditure (REE;kcal) will be determined using 
indirect calorimetry. Indirect calorimetry is a non-invasive method considered the gold 
standard for determining REE (23). Measurements of REE with IC will be performed in 
mechanically ventilated patients by connecting the device to the mechanical ventilator circuit, 
and spontaneously breathing patients by using a canopy hood placed over the patient’s head 
(24). We will use the Q-NRG® Portable Metabolic Monitor (Cosmed, Italy). The measured 
carbon dioxide production (VCO2) and oxygen consumption (VO2) obtained from the 
calorimeter will be used to calculate REE using Weir’s equation. The respiratory quotient, 
which is the ratio between VCO2 and VO2, will also be calculated (24).  
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Physical performance will be assessed using the Short Physical Performance Battery 
test, consisting of a balance test, a chair stand test and a gait speed test (25). Additionally, the 
hand grip strength test will assess arm muscle function, and will be performed using a 
hand-held dynamometer (26). To assess muscle mass we will measure body composition and 
muscle mass using bioelectrical impedance analysis (27) and ultrasound, respectively. The 
first one will only be measured when the participant is able to stand and meet at the outpatient 
clinic where the device is. The analysis is done according to the device, inserting weight, 
height and age. Regarding the ultrasound, this can be measured by the bed-side and we will 
measure only one point at the thigh, according to a validated protocol (USVALID) (28).  
 
Estimated time on level B: 45-60 minutes on each measurement point. Requires meet-up in 
the outpatient clinic.  
 
3.5.4 Blood tests (level C) 
Blood tests will be taken in  both groups (if given specific consent) at the four main 
measurement points, as well as at inclusion. About 50 ml of blood will be taken on each blood 
test. In group one, the tests will be taken and analyzed on the same day as follow-up with the 
dietitian, , but the researchers will be blinded, thus not knowing the results until after the 
follow-up period of each patient. Only the affiliated bioengineers analyzing the tests will 
know the results, and will collect these results in a separate excel-file with study ID-numbers. 
After the follow-up period has ended,  the patient and general practitioner will be contacted if 
there are any deviations from normal range. In group two, the clinical blood tests will also be 
taken and analyzed the same day as follow-up with the dietitian, but will not be blinded as the 
results will be a part of the assessment. 
 
Estimated time on level C: 15 minutes on each measurement point, including waiting time. 
Requires meet-up in the outpatient clinic.  
 
3.6 Statistics  
For endpoints with several time points, statistics will be evaluated as the difference of 
repeated measures over time between the groups, applying a mixed model for repeated 
measures. Where appropriate, differences will be investigated with Student’s t-test for 
normally distributed outcomes, and Wilcoxon rank-sum tests otherwise. As mentioned p<0.05 
will be considered statistically significant. Calculations will be performed with Microsoft 
Excel and Statistics will be performed with Graphpad Prism (version 10).  
 
3.7 Data management  
All collected data will be stored on a dedicated data server at UNN. All study 
participants will receive an ID-number (linkage key) kept in a separate file from the collected 
data, securing de-identification. The project manager and project members responsible for 
data collection, will have access to the linkage key. Study inclusion will be documented for 
each study participant in the electronic journal system Dips. Additionally, in the intervention 
group, information regarding the treatment and advice given will also be documented in Dips.  
Data may be transferred to our project collaborator in Sweden.  These data will be 
deleted when the project ends. The linkage key will not be shared. 
 
3.8 Communication and presentation 
The results of the project are outlined to be published in two publications in 
international renowned open access journals. All publication will be done according to the 
guidelines of Open Access publication and Plan S. We further aim to present the results at 
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international congresses such as the congress for ESPEN as well as national congresses for 
anesthesiology, surgery, internal medicine, primary care, dietitians and nurses. Furthermore, 
we want the results to be communicated to the Norwegian Directorate of Health and the 
Norwegian Institute of Public Health, in which project members can contribute to future 
national groups working on nutrition recommendations of critically ill patients both during 
hospital stay and after hospital discharge. In collaboration with our user participant, we will 
choose the channels of communicating the results to the media and organizations for patients 
and next of kin. 
 
4.0 Financing  
The PhD-project is financed by Helse Nord RHF from 2025-2028 (project number 
HNF1745-25).  
5.0 Ethical considerations 
Informed consent will be gathered from all participants. In these studies, the 
participants have critical illness and most often temporarily reduced consent. It can be 
burdensome for next of kin to decide on questions about research participation in the acute 
phase. However, experience from previous studies shows that the vast majority of relatives 
are positive about research in the ICU. Substitute consent for persons with reduced consent 
competence follows the guidelines from the Norwegian national research ethics committee for 
medicine. Participation is voluntary and withdrawal is allowed at all times during follow-up, 
without further obligation.  
Furthermore, there will be additional specific consent for both blood tests and 
additional physical measurements and tests. 
 
5.1 Risk-benefit analysis  
Participants in group one will have no direct benefits of participating in this study. 
They will receive standard treatment as other patients in the hospital. However, they will 
contribute with useful information that may improve the nutritional treatment of future 
critically ill patients.  
Participants consenting to blood tests will be informed if these show abnormal results. In such 
cases, we will also inform their general practitioner about these findings. Participants in group 
two will receive individualized nutrition treatment and counseling from a registered clinical 
dietitian. These participants may improve their nutritional intake, physical function and 
health-related quality of life by participating.  
We see few risks by participating in this project, apart from the burden that the 
participants may experience due to frequent follow-up and physical tests. Participants 
consenting to the physical tests and measurements have to meet in a fasting state (no food or 
drink intake that day). The appointment will be early in the day to prevent a long period of 
fasting. The physical tests may be exhausting. There will be an assessment whether it is safe 
to perform the test in advance, and the participants are free to abort the test if needed. 
Measurements of resting energy expenditure may feel claustrophobic for some participants. 
Thorough information of the measurement will be given to the participants prior to the 
measurements, and the measurement will not be performed if the participant is unwilling. The 
measurement can be stopped at any time point. Blood work may give pain in the incision site. 
All measurements, physical tests and blood work are performed by trained health personnel.  
 
 
References 
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