NCT03895853

Early Metabolic Resuscitation for Septic Shock

Early Metabolic Resuscitation: A Potential Solution to Multi-Organ Dysfunction Syndrome in Septic Shock

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Organ Failure
• Septic Shock
• Severe Sepsis

Interventions

Type	Name	Description
OTHER	Best Practice	Receive standard of care
DIETARY_SUPPLEMENT	early metabolic resuscitation	Given Intravenous

Timeline

• Start date: 2019-10-04
• Primary completion: 2020-05-04
• Completion: 2020-05-04
• First posted: 2019-03-29
• Last updated: 2024-10-29
• Results posted: 2021-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study