Liquid Nutrition Therapy in Reducing Multi-Organ Dysfunction Syndrome in Patients With Septic Shock

PRIMARY OBJECTIVES:

I. To assess the efficacy of administering early metabolic resuscitation with standard of
care (SC + EMR) in patients diagnosed with septic shock for reducing 28-day mortality versus
using the standard of care alone (SC).

SECONDARY OBJECTIVES:

I. To assess whether early metabolic resuscitation with standard of care (SC + EMR) is an
effective strategy to reduce intensive care unit (ICU) mortality, hospital mortality, and
90-day mortality of septic shock patients relative to SC.

II. To compare the time to death from any cause between patients administered SC + EMR versus
SC after being diagnosed with septic shock.

III. To assess whether SC + EMR is an effective strategy to reduce complications of septic
shock such as: i) acute kidney injury, ii) dialysis requirements, iii) need for
cardiovascular support or days on vasopressors, iv) need for invasive ventilation, days on
ventilator support, v) duration of ICU stay, and vi) duration of hospital stay versus SC.

IV. To describe the presence of any adverse effects between the two study groups (SC + EMR
group versus [vs] SC group); thus, characterizing their safety.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive standard of care for septic shock for up to 7 days.

GROUP II: Patients receive standard of care treatment for septic shock and liquid nutrition
therapy intravenously (IV) over continuous infusion for up to 7 days.

Inclusion Criteria:

- Admitted to the adult medical intensive care unit (MICU).

- Diagnosis of septic shock within 12 hours of ICU admission defined as meeting criteria
for sepsis in addition to the following: A) Vasopressor therapy needed to elevate mean
arterial pressure (MAP) >= 65 mmg Hg. B) Lactate > 2 mmol/L (18 mg/dL) after adequate
fluid resuscitation.

- Sequential Organ Failure Assessment (SOFA) score meeting the following requirements A)
Cardiovascular SOFA >= 2 B) Total SOFA score =< 12.

- Patients meeting the above and not able to tolerate enteral nutrition above 70% of
their estimated daily caloric need.

Exclusion Criteria:

- Do not resuscitate (DNR).

- Comfort care and end-of-life patients.

- Patients with SOFA scores greater than 12.

- Pregnant women.

- Jehovah Witnesses that do not accept albumin.

- Active bleeding (e.g., gastrointestinal bleeding).

- Acute neurological syndromes (e.g., stroke, hemorrhage, etc.).

- End-stage renal disease (ESRD).

- Chronic liver disease

- Child-Pugh class C

- Diagnosis of cirrhosis

- Heart rate less than 50 beats per minute (bpm).

- Respiratory rate less than 8 respirations per minute (rpm).

- Temperature less than 95 degrees Fahrenheit (F) or 35 degrees Celsius (C).

- Tumor lysis syndrome.

- Sulfite allergy: amino acids administration are contraindicated. It is more common in
steroid dependent asthmatics. (Please note that this is NOT sulfa allergy and is NOT
contraindicated patients with sulfa allergy). Sulfites are present in dried fruits,
beer, wines, sausages, jams, maple syrup, and many other food products.

- Serum sodium concentration < 130 mEq/L or > 150 mEq/L (Note: Once serum sodium levels
are >= 130 or =< 150 mEq/L within 12 hours after meeting inclusion criteria, the
patient can then be considered for the study. This is only a temporary restriction.

- Serum creatinine level: Serum creatinine (SCr) > 2.5 mg/dL (Note: Once serum
creatinine levels are =< 2.5 mg/dL within 12 hours after meeting inclusion criteria,
the patient can then be considered for the study. This is only a temporary
restriction).

- Urine output < 400 cc/24 hours (hrs) plus creatinine > 2.5 mq/dl (Note: Once urine
output levels are >= 400 cc within 12 hours after meeting inclusion criteria, the
patient can then be considered for the study. This is only a temporary restriction).

- Hyperkalemia K > 5.5 mEq/L (Note: Once potassium levels are =< 5.5 mEq/L within 12
hours after meeting inclusion criteria, the patient can then be considered for the
study. This is only a temporary restriction).

- Hyperglycemia: Glucose > 250 mg/dL (Note: Once glucose is below 250 mg/dL within 12
hours after meeting inclusion criteria, the patient can then be considered for the
study. This is only a temporary restriction.)

- Hyperphosphatemia: Serum phosphorous > 8.0 mg/dL.

- Patient with a history of metabolic abnormality in any one of the following amino
acids: alanine, arginine, cysteine hydrochloride, glycine, histidine, isoleucine,
leucine, lysine acetate, methionine, phenylalanine, phosphoric acid, proline, serine,
threonine, tryptophan, and valine.