Trial Outcomes & Findings for Early Metabolic Resuscitation for Septic Shock (NCT NCT03895853)
NCT ID: NCT03895853
Last Updated: 2024-10-29
Results Overview
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).
TERMINATED
PHASE2
2 participants
up to 28 days or until death, whichever comes first
2024-10-29
Participant Flow
Recruitment Period: November 2019- December 2019
Participant milestones
| Measure |
Intervention Group (EMR Solution)
Standard of care + Early metabolic resuscitation
|
Controlled Group (Standard Care)
Received standard of care alone
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
2
|
|
Overall Study
COMPLETED
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Metabolic Resuscitation for Septic Shock
Baseline characteristics by cohort
| Measure |
Intervention Group (EMR Solution)
Standard of care + Early metabolic resuscitation
|
Controlled Group (Standard Care)
n=2 Participants
Received standard of care alone
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
—
|
52 years
n=7 Participants
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
—
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
—
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Cancer Type
Gastrointestinal
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Cancer Type
Breast
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Cancer Type
Lung
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Cancer stage
Metastatic Stage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Cancer stage
Localized/Locally advanced
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 28 days or until death, whichever comes firstPopulation: No participants participated in the Intervention group.
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).
Outcome measures
| Measure |
Intervention Group (EMR Solution)
Standard of care + Early metabolic resuscitation
|
Controlled Group (Standard Care)
n=2 Participants
Received standard of care alone
|
|---|---|---|
|
Number of Participants With 28-day Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 90 days or until death, whichever comes firstPopulation: No participants participated in the Intervention group.
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.
Outcome measures
| Measure |
Intervention Group (EMR Solution)
Standard of care + Early metabolic resuscitation
|
Controlled Group (Standard Care)
n=2 Participants
Received standard of care alone
|
|---|---|---|
|
Number of Participants With 90-Day Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 90 days or until death, whichever comes firstPopulation: No participants participated in the Intervention group.
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.
Outcome measures
| Measure |
Intervention Group (EMR Solution)
Standard of care + Early metabolic resuscitation
|
Controlled Group (Standard Care)
n=2 Participants
Received standard of care alone
|
|---|---|---|
|
Number of Participants With Hospital Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 90-days or until death, whichever comes firstPopulation: No participants participated in the Intervention group.
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.
Outcome measures
| Measure |
Intervention Group (EMR Solution)
Standard of care + Early metabolic resuscitation
|
Controlled Group (Standard Care)
n=2 Participants
Received standard of care alone
|
|---|---|---|
|
Number of Participants With ICU Mortality
|
0 Participants
|
0 Participants
|
Adverse Events
Intervention Group (EMR Solution)
Controlled Group (Standard Care)
Serious adverse events
| Measure |
Intervention Group (EMR Solution)
Standard of care + Early metabolic resuscitation
|
Controlled Group (Standard Care)
n=2 participants at risk
Received standard of care alone
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypokalemia
|
—
0/0 • baseline, up to 1 year
No participants were enrolled in the Intervention Group
|
100.0%
2/2 • Number of events 7 • baseline, up to 1 year
No participants were enrolled in the Intervention Group
|
Other adverse events
Adverse event data not reported
Additional Information
Joseph L. Nates, Professor, Critical Care& RespiratoryCare
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place