Multiple Organ Failure, Septic Shock, Severe Sepsis
Conditions
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.
Interventions
OTHERBest Practice
Receive standard of care
DIETARY_SUPPLEMENTearly metabolic resuscitation
Given Intravenous
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 28-day Mortality | up to 28 days or until death, whichever comes first | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 90-Day Mortality | up to 90 days or until death, whichever comes first | 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 | up to 90 days or until death, whichever comes first | 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 | up to 90-days or until death, whichever comes first | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: November 2019- December 2019
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group (EMR Solution) Standard of care + Early metabolic resuscitation | 0 |
| Controlled Group (Standard Care) Received standard of care alone | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Controlled Group (Standard Care) | Total | Intervention Group (EMR Solution) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | — |
| Age, Continuous | 52 years | 52 years | — |
| Cancer stage Localized/Locally advanced | 1 Participants | 1 Participants | 0 Participants |
| Cancer stage Metastatic Stage | 0 Participants | 0 Participants | 0 Participants |
| Cancer Type Breast | 0 Participants | 0 Participants | 0 Participants |
| Cancer Type Gastrointestinal | 0 Participants | 0 Participants | 0 Participants |
| Cancer Type Lung | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | — |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | — |
| Region of Enrollment United States | 2 participants | 2 participants | — |
| Sex: Female, Male Female | 0 Participants | 0 Participants | — |
| Sex: Female, Male Male | 2 Participants | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 2 |
| other Total, other adverse events | 0 / 0 | 0 / 2 |
| serious Total, serious adverse events | 0 / 0 | 2 / 2 |
Outcome results
Primary
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).
Time frame: up to 28 days or until death, whichever comes first
Population: No participants participated in the Intervention group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group (EMR Solution) | Number of Participants With 28-day Mortality | 0 Participants |
| Controlled Group (Standard Care) | Number of Participants With 28-day Mortality | 0 Participants |
Secondary
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.
Time frame: up to 90 days or until death, whichever comes first
Population: No participants participated in the Intervention group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group (EMR Solution) | Number of Participants With 90-Day Mortality | 0 Participants |
| Controlled Group (Standard Care) | Number of Participants With 90-Day Mortality | 0 Participants |
Secondary
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.
Time frame: up to 90 days or until death, whichever comes first
Population: No participants participated in the Intervention group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group (EMR Solution) | Number of Participants With Hospital Mortality | 0 Participants |
| Controlled Group (Standard Care) | Number of Participants With Hospital Mortality | 0 Participants |
Secondary
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.
Time frame: up to 90-days or until death, whichever comes first
Population: No participants participated in the Intervention group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group (EMR Solution) | Number of Participants With ICU Mortality | 0 Participants |
| Controlled Group (Standard Care) | Number of Participants With ICU Mortality | 0 Participants |