Please select the eligibility criteria that correspond to the clinical trial below.
Title: Impact of Supplemental Parenteral Nutrition (SPN) on Infection Rate, Duration of Mechanical Ventilation and Rehabilitation in Intensive Care Unit Patients: A Quality Control Program for the Implementing of New Nutrition Guidelines
Brief Summary: Rationale: Enteral nutrition (EN) in the intensive care (ICU) patients is recommended as a standard of care. However, EN alone is often associated with insufficient energy intakes and increased complication rates. Recently the investigators proposed to decrease this deficit by combining EN and supplemental parenteral nutrition (SPN) whenever EN is insufficient (\< 60% of their predicted energy needs) at day 3 after admission in the ICU.

Objective: This study aims at: a/ investigating if the delivery of optimal nutrition support (100 % of predicted energy targets) in ICU patients by the combined administration of SPN and EN optimizes their clinical outcome; b/ implementing the new ICU nutrition guidelines.

Study design: Prospective, controlled, randomized clinical study.

Study site: Service of Intensive Care, Geneva University Hospital.

Patient population: 220 ICU patients to be included: expected length of stay \> 5 days, expected survival \> 7 days, no contraindication to EN, obtained informed consent from themselves or their next of keen.

Exclusion criteria: refusal of consent, age \< 18 years, short bowel syndrome, significant persistent gastrointestinal dysfunction with ileus, high output proximal fistula (\> 1,5 liter/d), patients receiving PN.

Nutrition: At day 3 after admission, if energy input is \< 60%; patients are randomized into either the "Control group" (EN alone) or the "SPN group" (EN + PN) to reach 100% of their predicted energy needs. Tight glycaemic control (target 6.0 to 8.3 mmol/l) to be achieved according to our local practice by insulin administration.

Study endpoints:

* Primary: nosocomial infections (CDC criteria)
* Secondary: Mechanical ventilation duration, ICU and hospital length of stay, antibiotic free days, ICU complications (extra-renal epuration, neurological, cardiac and respiratory complications), energy and protein balance, 28 days clinical outcome.


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:

* 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
C: Inclusion Criteria:

* Expected ICU stay \> 5 days
* Expected survival \> 7 days
* No contraindication to EN
* Obtained informed consent

Exclusion Criteria:

* Refusal of consent
* Age \< 18 years
* Short bowel syndrome
* Significant persistent gastrointestinal dysfunction with ileus
* High output proximal fistula (\> 1.5 liter/d)
* Patients receiving PN
D: 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

Answer: C