Critical IllnessPhase 4EAT-ICUNCT01372176

Early Goal-Directed Nutrition in ICU Patients - EAT-ICU Trial

A Phase 4 study testing Early Goal-Directed Nutrition and ASPEN-guidelines in people with Critical Illness and Intensive Care (ICU) Myopathy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

An increasing number of patients survive critical illness and intensive care, but describe having impaired physical function several years after discharge as a consequence of extensive loss of muscle mass. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Critical Illness, Intensive Care (ICU) Myopathy, Muscle Wasting
What is being tested?: Early Goal-Directed Nutrition and ASPEN-guidelines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 203 participants
Where: 1 siteDenmark
Study dates: Jun 2013to Nov 2016
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Acutely admitted to the ICU
Expected length of stay in ICU > 3 days
Mechanically ventilated, which enables indirect calorimetry
Have central venous catheter wherein TPN can be administered
Written proxy consent obtained (proxy consent defined as consent from two doctors, who are independent of the trial)
Must be able to understand Danish

Who cannot join

Contraindications to use enteral nutrition
Contraindications to use parenteral nutrition, eg. hypersensitivity towards fish-, egg or peanut protein, or any of the active substances in the PN products
Receiving a special diet
Burns > 10% total body surface area
Severe hepatic failure (Child-Pugh class C) or severe hepatic dysfunction: Bilirubin ≥ 50 µmol/l (3 mg/dl) + alanine aminotransferase ≥ 3 times upper reference value
Traumatic brain injury

Show all 12Show fewer

Diabetic ketoacidosis
Hyperosmolar non-ketotic acidosis
Known or suspected hyperlipidemia
BMI below 17 or severe malnutrition
Pregnancy
The clinician finds that the patient is too deranged (circulation, respiration, electrolytes etc.) or that death is imminent

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Department of Intensive Care, Rigshospitalet
Copenhagen, 2100

Other trials in Denmark

About this study

This randomised trial will investigate the effect of an optimised nutrition therapy during intensive care, on short term clinical outcome and physical quality of life. We hypothesise, that early nutritional therapy, directed towards patient-specific goals for energy and protein requirements, will improve both short- and long-term outcomes.

Conditions: Critical Illness, Intensive Care (ICU) Myopathy, Muscle Wasting, Loss of Physical Function, Mechanical Ventilation
Being tested: Early Goal-Directed Nutrition, ASPEN-guidelines
Keywords: Intensive care unit, Critical illness, Mortality, Reduced quality of life, Loss of lean body mass, Loss of physical function, Optimised nutritional support, Early initiation of nutrition, Indirect calorimetry
Medical subject headings: Critical Illness, Muscular Diseases, Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Early Goal-Directed NutritionOther
1. Initiation of early supplementary parenteral nutrition (≤ 24 hours of admission).
2. Measurement of requirements (indirect calorimetry, 24-hour urinary urea) leading to patient-specific, individualised and goal-directed nutritional therapy.
3. Intervention goal: delivering 100% of patient-specific requirements, measured or calculated throughout entire admission (EN+PN).
ASPEN-guidelinesOther
EN will be the preferred route of nutrition, and will be initiated within the first 24 hours of ICU admission, in accordance with best evidence. The amount is gradually increased over the first days of admission as tolerated by the patient (assessed from gastric aspirates). If EN fails to reach calculated goals at day 7, supplementary PN will be initiated at admission day 8 to reach goals. Protein and energy goals will be calculated as 25 kcal/kg/day and 1.2 g protein/kg/day.

Study groups in NCT01372176
Study group	Role	What they receive
Early Goal-Directed Nutrition	Experimental	Not described Receives: Other: Early Goal-Directed Nutrition
ASPEN-guidelines	Active comparator	Not described Receives: Other: ASPEN-guidelines

What is being measured

The primary outcome is the main question the study is designed to answer.

Physical function
Physical function 6 months after randomisation (physical component summary (PCS)-score of SF-36, conducted as phone-interview by a person blinded to the intervention
Measured: 6 months after randomisation

Secondary outcomes (17)

Mortality
Measured: 28 days
Mortality
Measured: 90 days
Mortality
Measured: 6 months
Survival status for all patients
Measured: 6 months
New organ failure in the ICU
SOFA score above 3 in every category ex. Glasgow Coma Scale Score
Measured: Followed until ICU discharge, an expected average of 21 days
Metabolic control
Accumulated insulin administration to maintain B-glucose ≤10 mmol/l and rates of severe hyper- and hypoglycaemia (B-glucose >15 mmol/l or ≤2.2 mmol/l, respectively)
Measured: Followed until ICU discharge, an expected average of 21 days
New onset of renal replacement therapy
Measured: Followed until ICU discharge, an expected average of 21 days
Accumulated energy- and protein balance
Measured: Followed until ICU discharge, an expected average of 21 days
Length of stay in ICU
Among survivors
Measured: Up to 52 weeks
Length of stay in hospital
Among survivors
Measured: Up to 52 weeks
Serious adverse reactions in ICU
Severe allergic reactions or elevated levels of liver enzymes in plasma
Measured: Up to 52 weeks
Health related quality of life
Assessed by SF-36 questionnaire
Measured: 6 months after randomisation
Rate of nosocomial infections
Defined in six subcategories by a person blinded for the intervention
Measured: Followed until ICU discharge, an expected average of 21 days
Percent days alive without inotropic/vasopressor support at day 90
Measured: Up to 90 days
Percent days alive without renal replacement therapy at day 90
Measured: Up to 90 days
Percent days alive without mechanical ventilation at day 90
Measured: Up to 90 days
Cost analyses
Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Nov 2016

First posted13 Jun 2011 (estimated)
Study startJun 2013
Primary completionNov 2016
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Critical IllnessStudies of the same condition, open and under way.
More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 203 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01372176
Sponsor's protocol ID: 2011-002547-94
Acronym: EAT-ICU
Status last verified: Jan 2017
First submitted: 6 Jun 2011
Last updated: 5 Jan 2017
Results posted: No
Data monitoring committee: Yes

Publications

Allingstrup MJ, Kondrup J, Wiis J, Claudius C, Pedersen UG, Hein-Rasmussen R, Bjerregaard MR, Steensen M, Jensen TH, Lange T, Madsen MB, Moller MH, Perner A. Early goal-directed nutrition versus standard of care in adult intensive care patients: the single-centre, randomised, outcome assessor-blinded EAT-ICU trial. Intensive Care Med. 2017 Nov;43(11):1637-1647. doi: 10.1007/s00134-017-4880-3. Epub 2017 Sep 22.
PubMed 28936712
Allingstrup MJ, Kondrup J, Wiis J, Claudius C, Pedersen UG, Hein-Rasmussen R, Jensen TH, Lange T, Perner A. Early goal-directed nutrition in ICU patients (EAT-ICU): protocol for a randomised trial. Dan Med J. 2016 Sep;63(9):A5271.
PubMed 27585532

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness

All Critical Illness trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Goal-Directed Nutrition in ICU Patients - EAT-ICU Trial
ClinicalTrials.gov ID: NCT01372176
Acronym / sponsor ID: EAT-ICU / 2011-002547-94
Conditions: Critical Illness, Intensive Care (ICU) Myopathy, Muscle Wasting, Loss of Physical Function, Mechanical Ventilation
Keywords: Intensive care unit, Critical illness, Mortality, Reduced quality of life, Loss of lean body mass, Loss of physical function, Optimised nutritional support, Early initiation of nutrition
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 203 participants (actual)
Lead sponsor: Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
Collaborators: University of Copenhagen, Fresenius Kabi, European Society for Clinical Nutrition and Metabolism
Study start: Jun 2013
Primary completion: Nov 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 13 Jun 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Early Goal-Directed Nutrition	Experimental	Other: Early Goal-Directed Nutrition
ASPEN-guidelines	Active comparator	Other: ASPEN-guidelines

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Acutely admitted to the ICU
Expected length of stay in ICU > 3 days
Mechanically ventilated, which enables indirect calorimetry
Have central venous catheter wherein TPN can be administered
Written proxy consent obtained (proxy consent defined as consent from two doctors, who are independent of the trial)

Key exclusion criteria (12 listed)

Contraindications to use enteral nutrition
Contraindications to use parenteral nutrition, eg. hypersensitivity towards fish-, egg or peanut protein, or any of the active substances in the PN products
Receiving a special diet
Burns > 10% total body surface area
Severe hepatic failure (Child-Pugh class C) or severe hepatic dysfunction: Bilirubin ≥ 50 µmol/l (3 mg/dl) + alanine aminotransferase ≥ 3 times upper reference value

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Early Goal-Directed Nutrition1. Initiation of early supplementary parenteral nutrition (≤ 24 hours of admission). 2. Measurement of requirements (indirect calorimetry, 24-hour urinary urea) leading to patient-specific, individualised and goal-directed nutritional therapy. 3. Intervention goal: delivering 100% of patient-specific requirements, measured or calculated throughout entire admission (EN+PN).	Other	Early Goal-Directed Nutrition
ASPEN-guidelinesEN will be the preferred route of nutrition, and will be initiated within the first 24 hours of ICU admission, in accordance with best evidence. The amount is gradually increased over the first days of admission as tolerated by the patient (assessed from gastric aspirates). If EN fails to reach calculated goals at day 7, supplementary PN will be initiated at admission day 8 to reach goals. Protein and energy goals will be calculated as 25 kcal/kg/day and 1.2 g protein/kg/day.	Other	ASPEN-guidelines

Primary outcome

Physical function
Time frame: 6 months after randomisation
Physical function 6 months after randomisation (physical component summary (PCS)-score of SF-36, conducted as phone-interview by a person blinded to the intervention

17 secondary outcomes

Mortality
Time frame: 28 days
Mortality
Time frame: 90 days
Mortality
Time frame: 6 months
Survival status for all patients
Time frame: 6 months
New organ failure in the ICU
Time frame: Followed until ICU discharge, an expected average of 21 days
Metabolic control
Time frame: Followed until ICU discharge, an expected average of 21 days
New onset of renal replacement therapy
Time frame: Followed until ICU discharge, an expected average of 21 days
Accumulated energy- and protein balance
Time frame: Followed until ICU discharge, an expected average of 21 days
Length of stay in ICU
Time frame: Up to 52 weeks
Length of stay in hospital
Time frame: Up to 52 weeks
Serious adverse reactions in ICU
Time frame: Up to 52 weeks
Health related quality of life
Time frame: 6 months after randomisation
Rate of nosocomial infections
Time frame: Followed until ICU discharge, an expected average of 21 days
Percent days alive without inotropic/vasopressor support at day 90
Time frame: Up to 90 days
Percent days alive without renal replacement therapy at day 90
Time frame: Up to 90 days
Percent days alive without mechanical ventilation at day 90
Time frame: Up to 90 days
Cost analyses
Time frame: Up to 52 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
Derived from this study: PubMed 28936712Allingstrup MJ, Kondrup J, Wiis J, Claudius C, Pedersen UG, Hein-Rasmussen R, Bjerregaard MR, Steensen M, Jensen TH, Lange T, Madsen MB, Moller MH, Perner A. Early goal-directed nutrition versus standard of care in adult intensive care patients: the single-centre, randomised, outcome assessor-blinded EAT-ICU trial. Intensive Care Med. 2017 Nov;43(11):1637-1647. doi: 10.1007/s00134-017-4880-3. Epub 2017 Sep 22.
Derived from this study: PubMed 27585532Allingstrup MJ, Kondrup J, Wiis J, Claudius C, Pedersen UG, Hein-Rasmussen R, Jensen TH, Lange T, Perner A. Early goal-directed nutrition in ICU patients (EAT-ICU): protocol for a randomised trial. Dan Med J. 2016 Sep;63(9):A5271.

Related trials for Critical Illness

RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anders Perner, Professor, MD, PhD principal investigator

Rigshospitalet, Department of Intensive Care

Matilde Jo Allingstrup, PhD Fellow, MSc study director

Rigshospitalet, Department of Intensive Care

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical function (time frame: 6 months after randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01372176, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2017.