Back to resultsEarly Metabolic Resuscitation for Septic Shock
Primary Purpose
Multiple Organ Failure, Septic Shock, Severe Sepsis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Best Practice
early metabolic resuscitation
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Organ Failure
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.
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group I (standard of care)
Group II (early metabolic resuscitation)
Arm Description
Patients receive standard of care for septic shock.
Patients receive standard of care treatment for septic shock and early metabolic resuscitation (IV) over continuous infusion for up to 7 days.
Outcomes
Primary Outcome Measures
Number of Participants With 28-day Mortality
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). Twenty-eight day mortality is defined during the time from the day SC+EMR or SC was first administered until a patient dies or is followed through 28 days (whichever comes first).
Secondary Outcome Measures
Number of Participants With 90-Day Mortality
To assess whether Early Metabolic Resuscitation with standard of care (SC + EMR) is an effective strategy to reduce ICU mortality, hospital mortality, and 90-day mortality of septic shock patients relative to SC. ICU mortality is defined as mortality at ICU discharge relative to SC.
Number of Participants With Hospital Mortality
To assess whether Early Metabolic Resuscitation with standard of care (SC + EMR) is an effective strategy to reduce hospital mortality of septic shock patients relative to SC.
Number of Participants With ICU Mortality
To assess whether Early Metabolic Resuscitation with standard of care (SC + EMR) is an effective strategy to reduce ICU mortality of septic shock patients relative to SC. ICU mortality is defined as mortality at ICU discharge relative to SC.
Full Information
NCT ID
NCT03895853
First Posted
March 28, 2019
Last Updated
March 11, 2021
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03895853
Brief Title
Early Metabolic Resuscitation for Septic Shock
Official Title
Early Metabolic Resuscitation: A Potential Solution to Multi-Organ Dysfunction Syndrome in Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
At the request of the PI
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
May 4, 2020 (Actual)
Study Completion Date
May 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Organ Failure, Septic Shock, Severe Sepsis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I (standard of care)
Arm Type
Active Comparator
Arm Description
Patients receive standard of care for septic shock.
Arm Title
Group II (early metabolic resuscitation)
Arm Type
Experimental
Arm Description
Patients receive standard of care treatment for septic shock and early metabolic resuscitation (IV) over continuous infusion for up to 7 days.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive standard of care
Intervention Type
Dietary Supplement
Intervention Name(s)
early metabolic resuscitation
Other Intervention Name(s)
hyperalimentation, EMR, glucose, protein, essential metabolic molecules
Intervention Description
Given Intravenous
Primary Outcome Measure Information:
Title
Number of Participants With 28-day Mortality
Description
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). Twenty-eight day mortality is defined during the time from the day SC+EMR or SC was first administered until a patient dies or is followed through 28 days (whichever comes first).
Time Frame
up to 28 days or until death, whichever comes first
Secondary Outcome Measure Information:
Title
Number of Participants With 90-Day Mortality
Description
To assess whether Early Metabolic Resuscitation with standard of care (SC + EMR) is an effective strategy to reduce ICU mortality, hospital mortality, and 90-day mortality of septic shock patients relative to SC. ICU mortality is defined as mortality at ICU discharge relative to SC.
Time Frame
up to 90 days or until death, whichever comes first
Title
Number of Participants With Hospital Mortality
Description
To assess whether Early Metabolic Resuscitation with standard of care (SC + EMR) is an effective strategy to reduce hospital mortality of septic shock patients relative to SC.
Time Frame
up to 90 days or until death, whichever comes first
Title
Number of Participants With ICU Mortality
Description
To assess whether Early Metabolic Resuscitation with standard of care (SC + EMR) is an effective strategy to reduce ICU mortality of septic shock patients relative to SC. ICU mortality is defined as mortality at ICU discharge relative to SC.
Time Frame
up to 90-days or until death, whichever comes first
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph L. Nates, MBA,MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website
Learn more about this trial
Early Metabolic Resuscitation for Septic Shock
We'll reach out to this number within 24 hrs