A Phase 2 interventional study of Best Practice and early metabolic resuscitation in Multiple Organ Failure, Septic Shock and Severe Sepsis, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-29.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Supportive care
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.
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.
162 studies on the registry are indexed under Multiple Organ Failure; 44 are open to participants now.
This study's enrollment of 2 is below the median of 75 across 77 interventional studies indexed under Multiple Organ Failure.
Browse Multiple Organ Failure studies →M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.
Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.
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Exclusion Criteria:
Chronic liver disease
Patients receive standard of care for septic shock.
Other: Best Practice
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 · Dietary Supplement: early metabolic resuscitation
Receive standard of care
Also known as: standard of care, standard therapy
Given Intravenous
Also known as: hyperalimentation, EMR, glucose, protein, essential metabolic molecules
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
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
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
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
Recruitment Period: November 2019- December 2019
| Milestone | Intervention Group (EMR Solution) | Controlled Group (Standard Care) |
|---|---|---|
| Started | 0 | 2 |
| Completed | 0 | 2 |
| Not completed | 0 | 0 |
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).
| Participants | Intervention Group (EMR Solution) | Controlled Group (Standard Care) |
|---|---|---|
| Number of Participants With 28-day Mortality | 0 | 0 |
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.
| Participants | Intervention Group (EMR Solution) | Controlled Group (Standard Care) |
|---|---|---|
| Number of Participants With 90-Day Mortality | 0 | 0 |
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.
| Participants | Intervention Group (EMR Solution) | Controlled Group (Standard Care) |
|---|---|---|
| Number of Participants With Hospital Mortality | 0 | 0 |
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.
| Participants | Intervention Group (EMR Solution) | Controlled Group (Standard Care) |
|---|---|---|
| Number of Participants With ICU Mortality | 0 | 0 |
Collected over baseline, up to 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group (EMR Solution) | — | — | — |
| Controlled Group (Standard Care) | 0/2 (0%) | 2/2 (100%) | 0/2 (0%) |
| Event | Intervention Group (EMR Solution) | Controlled Group (Standard Care) |
|---|---|---|
| HypokalemiaMetabolism and nutrition disorders | — | 2/2 |
No patients were enrolled in the Intervention group.
| Age, Categorical(Participants) | Intervention Group (EMR Solution) | Controlled Group (Standard Care) | Total |
|---|---|---|---|
| <=18 years | — | 0 | 0 |
| Between 18 and 65 years | — | 1 | 1 |
| >=65 years | — | 1 | 1 |
| Age, Continuous(years) | Intervention Group (EMR Solution) | Controlled Group (Standard Care) | Total |
|---|---|---|---|
| Mean | — | 52 (33 to 71) | 52 (33 to 71) |
| Sex: Female, Male(Participants) | Intervention Group (EMR Solution) | Controlled Group (Standard Care) | Total |
|---|---|---|---|
| Female | — | 0 | 0 |
| Male | — | 2 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Group (EMR Solution) | Controlled Group (Standard Care) | Total |
|---|---|---|---|
| Hispanic or Latino | — | 0 | 0 |
| Not Hispanic or Latino | — | 2 | 2 |
| Unknown or Not Reported | — | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention Group (EMR Solution) | Controlled Group (Standard Care) | Total |
|---|---|---|---|
| American Indian or Alaska Native | — | 0 | 0 |
| Asian | — | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | — | 0 | 0 |
| Black or African American | — | 1 | 1 |
| White | — | 1 | 1 |
| More than one race | — | 0 | 0 |
| Unknown or Not Reported | — | 0 | 0 |
| Region of Enrollment(participants) | Intervention Group (EMR Solution) | Controlled Group (Standard Care) | Total |
|---|---|---|---|
| United States | — | 2 | 2 |
| Cancer Type(Participants) | Intervention Group (EMR Solution) | Controlled Group (Standard Care) | Total |
|---|---|---|---|
| Gastrointestinal | 0 | 0 | 0 |
| Breast | 0 | 0 | 0 |
| Lung | 0 | 1 | 1 |
| Cancer stage(Participants) | Intervention Group (EMR Solution) | Controlled Group (Standard Care) | Total |
|---|---|---|---|
| Metastatic Stage | 0 | 0 | 0 |
| Localized/Locally advanced | 0 | 1 | 1 |
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Studies of the drug tested here: Glucose