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Early Metabolic Resuscitation for Septic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03895853
Recruitment Status : Terminated (At the request of the PI)
First Posted : March 29, 2019
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Organ Failure Septic Shock Severe Sepsis Other: Best Practice Dietary Supplement: early metabolic resuscitation Phase 2

Detailed Description:

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.

GROUP II: Patients receive standard of care treatment for septic shock and early metabolic resuscitation (IV) over continuous infusion for up to 7 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Early Metabolic Resuscitation: A Potential Solution to Multi-Organ Dysfunction Syndrome in Septic Shock
Actual Study Start Date : October 4, 2019
Actual Primary Completion Date : May 4, 2020
Actual Study Completion Date : May 4, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Active Comparator: Group I (standard of care)
Patients receive standard of care for septic shock.
Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy

Experimental: Group II (early metabolic resuscitation)
Patients receive standard of care treatment for septic shock and early metabolic resuscitation (IV) over continuous infusion for up to 7 days.
Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy

Dietary Supplement: early metabolic resuscitation
Given Intravenous
Other Names:
  • hyperalimentation
  • EMR
  • glucose
  • protein
  • essential metabolic molecules




Primary Outcome Measures :
  1. 28-day mortality rate with early metabolic resuscitation and standard of care [ Time Frame: At 28 days ]
    A two-sided chi-square test with 0.05 significance level will be used.

  2. 28-day mortality rate with standard of care [ Time Frame: At 28 days ]
    A two-sided chi-square test with 0.05 significance level will be used.


Secondary Outcome Measures :
  1. Intensive care unit (ICU) mortality [ Time Frame: up to 90 days ]
  2. Hospital mortality [ Time Frame: up to 90 days ]
  3. 90-day mortality [ Time Frame: up to 90 days ]
  4. Incidence of acute kidney injury [ Time Frame: up to 90 days ]
  5. Time on cardiovascular support [ Time Frame: up to 90 days ]
  6. Time on ventilator [ Time Frame: up to 90 days ]
  7. Length of ICU stay [ Time Frame: up to 90 days ]
  8. Length of hospital stays [ Time Frame: up to 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895853


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Joseph L. Nates, MBA,MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03895853    
Other Study ID Numbers: 2018-0986
NCI-2019-01392 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0986 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Shock, Septic
Sepsis
Shock
Multiple Organ Failure
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation