Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients: The TOP UP Trial (Pilot)
Brief Summary: The specific aim of the proposed study is to conduct a pilot study involving 160 critically-ill lean and obese patients enrolled at 11 sites in Canada, the United States of America, Belgium and France in order to:

Specific Aims

* Confirm that we can achieve a clinically significant difference in calorie and protein intake between the two intervention groups.
* Estimate recruitment rate i.e. number of eligible and enrolled patients per month per site.
* Evaluate the safety, tolerance, and logistics around providing supplemental PN in the study population in the context of a multicenter trial, e.g.

  * To ensure adequate glycemic control in both groups.
  * To ensure that the other metabolic consequences of the feeding strategies are minimized.
  * To establish adequate compliance with study protocols and completion of case report forms

A secondary aim of this pilot study will be:

• To explore the effect of differential effects of calorie and protein delivery on muscle and mass function.


Options:
A: 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
B: 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
C: Inclusion Criteria:

* Must meet the following three criteria within a 24-hour period of study entry: 1) PaO2/FiO2 less than or equal to 300 (if altitude is more than 1000 meters, then PaO2/FiO2 less than or equal to 300 x \[barometric pressure/760\]), 2) bilateral infiltrates (patchy, diffuse, homogeneous, or asymmetric) consistent with pulmonary edema on frontal chest radiograph, and 3) requirement for positive pressure ventilation via endotracheal tube
* No clinical evidence of left-sided cardiac failure to account for bilateral pulmonary infiltrates
* Intention of primary medical team to enterally feed the patient
* Undergoes enteral feeding within 48 hours of meeting other inclusion criteria

Exclusion Criteria:

* Neuromuscular disease that impairs ability to breathe without assistance, such as cervical spinal cord injury at level C5 or higher, amyotrophic lateral sclerosis, Guillain-Barré syndrome, or myasthenia gravis
* Pregnant or breastfeeding
* Severe chronic respiratory disease (more information about this criterion can be found in the protocol)
* Burns on greater than 40% total body surface area
* Cancer or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50% (more information about this criterion can be found in the protocol)
* Allogeneic bone marrow transplant in the 5 years before study entry
* Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
* Severe long-term liver disease (Child-Pugh score of 11 to 15)
* Diffuse alveolar hemorrhage from vasculitis
* Morbid obesity, defined as 1 kg/cm body weight
* Unwilling or unable to use the ARDS network 6 mL/kg PBW ventilation protocol
* Moribund patient not expected to survive 24 hours after study entry
* No intent to obtain central venous access for monitoring intravascular pressures
* More than 72 hours since mechanical ventilation initiated
* Refractory shock (more information about this criterion can be found in the protocol)
* Unable to obtain enteral access
* Presence of partial or complete mechanical bowel obstruction
* Presence of ischemia or infarction
* Current total parenteral nutrition (TPN) use or intent to use TPN within 7 days of study entry
* Severe malnutrition with body mass index less than 18.5 or loss of more than 30% total body weight in the 6 months before study entry
* Laparotomy expected within 7 days of study entry
* Unable to raise head of bed 30 to 45 degrees
* Short-bowel syndrome or absence of gastrointestinal tract
* Presence of high-output (greater than 500 cc/day) enterocutaneous fistula
* International normalized ratio greater than 5.0, platelet count less than 30,000/mm3, or history of bleeding disorder
* Intracranial hemorrhage in the 1 month before study entry
* Allergy to enteral formula
* Requirement for, or physician insistence on, enteral formula supplemented with omega-3 fatty acids (e.g., Oxepa®, Impact®) or treatment with omega-3 fatty acid, gamma-linolenic acid (GLA), or antioxidant supplementation
D: Inclusion Criteria:

* Treatment with invasive mechanical ventilation
* Feeding via nasogastric tube within 36 hours after the initiation of endotracheal mechanical ventilation.
* Age over 18 years
* Informed consent

Exclusion Criteria:

* Mechanical ventilation started more than 36 hours before institution of enteral feeding
* Patients turned in the prone position at inclusion
* Abdominal surgery within 1 month before inclusion
* History of esophageal or gastric surgery
* EN via a gastrostomy or a jejunostomy
* Bleeding from esophagus, stomach or bowel
* Moribund patient
* Age less than 18 years
* Pregnancy.
* No informed consent.

Answer: A