Please select the eligibility criteria that correspond to the clinical trial below.
Title: Supplemental Parenteral Nutrition in Critically Ill Adults: A Pilot Randomised Controlled Trial
Brief Summary: One of the essential treatments for assisting patients in their recovery from illness is the provision of nutrition in a liquid form which is delivered into the stomach or as a fluid into the vein. Until recently the benefits of nutrition were undervalued in the critically ill, however, it has now become clear that targeted nutrition can positively affect a person's outcome. This is particularly important for patients who are significantly unwell and require increased amounts of nutrition to support recovery. Inadequate nutrition therapy leads them to rapidly lose weight, predominantly in the form of muscle loss which greatly contributes to their poor recovery.

Whilst nutrition is essential for recovery, there are several issues with the delivery of nutrition via the stomach (the most commonly used method of delivering nutrition in the critically ill). For many reasons, patients are unable to tolerate large quantities of nutrition via the stomach and in addition to this there are hospital or procedural reasons for nutrition being turned off for lengthy periods of time. As such, this results in patients being delivered only about half of the nutrition that is planned. One potential way to overcome this is to deliver nutrition via the vein, whilst nutrition into the stomach continues, with the aim to meet the energy gap that is lost by inadequate nutrition via the stomach.

In this study of 100 patients, we will deliver combined nutrition via the vein and stomach in 50 patients and the other 50 patients will receive nutrition as per normal practice. We will measure important outcomes for these patients to determine if this allows us to meet significantly more of their nutrition needs. This study will also help us determine how best to design a larger study of this strategy.


Options:
A: Inclusion Criteria:

Patients in intensive care who meet all of the following:

* Admitted to intensive care between 48 hours and 72 hours previously
* Mechanically ventilated at the time of enrollment and expected to remain ventilated until the day after tomorrow
* At least 16 years of age
* Have central venous access suitable for PN solution administration
* Have 1 or more organ system failure (respiratory, cardiovascular or renal) related to their acute illness defined as:

  1. Partial pressure of oxygen (PaO2) / Fraction of Inspired oxygen (FiO2) ratio ≤ 300 mmHg
  2. Currently on 1 or more continuous vasopressor infusion which were started at least 4 hours ago at a minimum dose of :

     1. Dopamine greater than 5 mcg/kg/min
     2. Noradrenaline ≥ 0.1mcg/kg/min
     3. Adrenaline ≥ 0.1 mcg/kg/min
     4. Any dose of total vasopressin
     5. Milrinone \>0.25mcg/kg/min)
  3. Renal dysfunction defined as

     In patients without known renal disease:
     1. serum creatinine \> 171 mmol/l OR
     2. Currently receiving renal replacement therapy

        In patients with known renal disease:
     3. an absolute increase of \> 50% in creatinine from baseline OR
     4. Currently receiving renal replacement therapy
  4. Currently has an intracranial pressure monitor or ventricular drain in situ
  5. Currently receiving extracorporeal membrane oxygenation
  6. Currently has a ventricular assist device

Exclusion Criteria:

* Both EN and PN cannot be delivered at enrollment (i.e. either an enteral tube or a central venous catheter cannot be placed or clinicians feel that EN or PN cannot be safely administered due to any other reason).
* Currently receiving PN
* Standard PN solutions cannot be delivered at enrolment (i.e. clinicians believe that a patient definitely needs a specific parenteral nutrition formulation (e.g. glutamine-supplementation or specific lipid formulation).
* Death is imminent or deemed highly likely in the next 96 hours.
* There is a current treatment limitation in place or the patient is unlikely to survive to 6 months due to underlying illness
* More than 80% of energy requirements have been satisfactorily delivered via the enteral route in the last 24 hours.
* Are known to be pregnant
B: Inclusion Criteria:

1. Patients admitted to any of the five intensive care units
2. Older than 18 years
3. Nutritional risk screening score (NRS) higher or equal to three upon ICU admission

Exclusion Criteria:

1. Patients with a do not resuscitate (DNR) code or moribund at the time of ICU admission
2. Patients already enrolled in another trial
3. Patients transferred from another intensive care unit with an established nutritional therapy
4. Patients suffering from ketoacidotic or hyperosmolar coma on admission
5. Patients with a body mass index (BMI) below 17 kg/m\^2
6. Short bowel syndrome
7. Patients known to be pregnant or nursing
8. Patients on mechanical ventilation at home
9. NRS score lower than three
10. Patient readmitted to ICU after randomization to the EPaNIC trial.
11. Patient not critically ill on admission. (No clinical indication for central intravenous catheter or patient ready for oral nutrition on admission.)
C: Inclusion Criteria:

* Critically ill adult patient (≥ 18 years) admitted to ICU
* Has acute respiratory failure (ARF) i.e. expected to remain mechanically ventilated for more than 48 hours
* Expected ICU dependency of 5 or more days
* On or expected to initiate enteral nutrition within 7 days of ICU admission
* BMI \<25 or ≥ 35 based on pre-ICU actual or estimated dry weight

Exclusion Criteria:

* \>72 hours from admission to ICU to time of consent
* Not expected to survive an additional 48 hrs from screening evaluation
* A lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated DNR acceptable)
* Patients already receiving PN at screening
* Absence of All gastrointestinal risk factors, defined as:

  1. High Apache II Score (\>20)
  2. On more than 1 vasopressor or increasing doses or vasopressors
  3. Receiving continuous infusion of narcotics
  4. High nasogastric/orogastric output (\>500 mL over 24 hours)
  5. Recent surgery involving esophagus, stomach, or small bowel OR peritoneal contamination with bowel contents
  6. Pancreatitis
  7. Multiple gastrointestinal investigations
  8. Recent history of diarrhea/C. Difficile
  9. Surgical patients with future surgeries planned
  10. Ruptured or dissected abdominal aortic aneurysm
* Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma
* Pregnant or lactating patients
* Patients with clinical fulminant hepatic failure
* Patients with Cirrhosis Child's Class C Liver Disease (except those on a transplant list or transplantable)
* Dedicated port of central line not available
* Known allergy to study nutrients (soy, eggs or olive products)
* Enrolment in another industry sponsored ICU intervention study
D: 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

Answer: A