Early Metabolic Resuscitation for Septic Shock
Condition: Multiple Organ Failure; Septic Shock; Severe Sepsis
MeSH terms: Shock, Septic; Sepsis; Shock; Multiple Organ Failure
Intervention: Best Practice; early metabolic resuscitation
Intervention description: Receive standard of care; Given Intravenous
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well early metabolic resuscitation therapy works in reducing
      multi-organ dysfunction in patients with septic shock. Early metabolic resuscitation is made
      of large doses of glucose, protein, and essential metabolic molecules that may help lower the
      effects of septic shock on the body. Giving patients early metabolic resuscitation in
      combination with standard of care may work better in reducing multi-organ dysfunction
      syndrome in patients with septic shock compared to standard of care alone.
    

Eligibility criteria:

        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 > 5.5 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.