Early Goal-Directed Nutrition in ICU Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-11-30

Brief Summary

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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. Reasons for loss of muscle mass and physical function are multiple, but insufficient nutrition is likely to contribute.

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.

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Detailed Description

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Conditions

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Critical Illness Intensive Care (ICU) Myopathy Muscle Wasting Loss of Physical Function Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early Goal-Directed Nutrition

Group Type EXPERIMENTAL

Early Goal-Directed Nutrition

Intervention Type OTHER

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-guidelines

Group Type ACTIVE_COMPARATOR

ASPEN-guidelines

Intervention Type OTHER

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.

Interventions

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Early Goal-Directed Nutrition

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).

Intervention Type OTHER

ASPEN-guidelines

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No