Early Metabolic Resuscitation for Septic Shock

NCT03895853 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: 2018-0986NCI-2019-01392P30CA016672
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Organ Failure; Septic Shock; Severe Sepsis

Outcome Measures

Primary Outcomes (1)

• 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).

  up to 28 days or until death, whichever comes first

Secondary Outcomes (3)

• Number of Participants With 90-Day Mortality

  up to 90 days or until death, whichever comes first

• Number of Participants With Hospital Mortality

  up to 90 days or until death, whichever comes first

• Number of Participants With ICU Mortality

  up to 90-days or until death, whichever comes first

Study Arms (2)

Group I (standard of care)

ACTIVE COMPARATOR

Patients receive standard of care for septic shock.

Other: Best Practice

Group II (early metabolic resuscitation)

EXPERIMENTAL

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

Interventions

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

Group I (standard of care); Group II (early metabolic resuscitation)

early metabolic resuscitation DIETARY_SUPPLEMENT

Given Intravenous

Also known as: hyperalimentation, EMR, glucose, protein, essential metabolic molecules

Group II (early metabolic resuscitation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Multiple Organ Failure; Shock, Septic; Sepsis

Interventions

Practice Guidelines as Topic; Standard of Care; Parenteral Nutrition; Glucose; Proteins

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy; Hexoses; Monosaccharides; Sugars; Carbohydrates; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Joseph L. Nates, Professor, Critical Care& RespiratoryCare
• Organization: UT MD Anderson Cancer Center

jlnates@mdanderson.org

(713) 792-5040

Study Officials

• Joseph L. Nates, MBA,MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: March 29, 2019
• Study Start: October 4, 2019
• Primary Completion: May 4, 2020
• Study Completion: May 4, 2020
• Last Updated: October 29, 2024
• Results First Posted: April 8, 2021

Record last verified: 2021-03

Locations

US (1)