NCT03895853

Early Metabolic Resuscitation for Septic Shock

Terminated Phase 2 Results posted Last updated 29 October 2024

What this trial tests

Phase 2 trial testing Best Practice in Multiple Organ Failure in 2 participants. Terminated before completion.

Timeline

4 October 2019

Primary endpoint
4 May 2020

4 May 2020

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	2
Start date	4 October 2019
Primary completion	4 May 2020
Estimated completion	4 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Best Practice
• early metabolic resuscitation

Conditions studied

• Multiple Organ Failure — all drugs for Multiple Organ Failure →
• Septic Shock — all drugs for Septic Shock →
• Severe Sepsis — all drugs for Severe Sepsis →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Multiple Organ Failure or Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With 28-day Mortality Primary · 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).

Group	Value	95% CI
Intervention Group (EMR Solution)	0
Controlled Group (Standard Care)	0

Number of Participants With 90-Day Mortality Secondary · 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.

Group	Value	95% CI
Intervention Group (EMR Solution)	0
Controlled Group (Standard Care)	0

Number of Participants With Hospital Mortality Secondary · 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.

Group	Value	95% CI
Intervention Group (EMR Solution)	0
Controlled Group (Standard Care)	0

Number of Participants With ICU Mortality Secondary · 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.

Group	Value	95% CI
Intervention Group (EMR Solution)	0
Controlled Group (Standard Care)	0

Adverse events — posted to ClinicalTrials.gov

Time frame: baseline, up to 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention Group (EMR Solution)

Serious: 0

Deaths: 0

Controlled Group (Standard Care)

Serious: 2/2 (100%)

Deaths: 0/2

Serious adverse events (1 terms)

Reaction	System	Intervention Group (EMR So…	Controlled Group (Standard…
Hypokalemia	Metabolism and nutrition disorders	—	—

Most-reported serious reactions: Hypokalemia.

Data from ClinicalTrials.gov NCT03895853 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.