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TerminatedNCT03895853Updated Oct 29, 2024Results posted

Early Metabolic Resuscitation for Septic Shock

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

Why this study was terminated
At the request of the PI
Phase
Phase 2
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Organ Failure
  • Septic Shock
  • Severe Sepsis
03

In context

Multiple Organ Failure

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Sulfite allergy: amino acids administration are contraindicated. It is more common in steroid dependent asthmatics. (Please note that this is NOT sulfa allergy and is NOT contraindicated patients with sulfa allergy). Sulfites are present in dried fruits, beer, wines, sausages, jams, maple syrup, and many other food products.
  • Serum sodium concentration \< 130 mEq/L or > 150 mEq/L (Note: Once serum sodium levels are >= 130 or =\< 150 mEq/L within 12 hours after meeting inclusion criteria, the patient can then be considered for the study. This is only a temporary restriction.
  • Serum creatinine level: Serum creatinine (SCr) > 2.5 mg/dL (Note: Once serum creatinine levels are =\< 2.5 mg/dL within 12 hours after meeting inclusion criteria, the patient can then be considered for the study. This is only a temporary restriction).
  • Urine output \< 400 cc/24 hours (hrs) plus creatinine > 2.5 mq/dl (Note: Once urine output levels are >= 400 cc within 12 hours after meeting inclusion criteria, the patient can then be considered for the study. This is only a temporary restriction).
  • Hyperkalemia K > 5.5 mEq/L (Note: Once potassium levels are =\< 5.5 mEq/L within 12 hours after meeting inclusion criteria, the patient can then be considered for the study. This is only a temporary restriction).
  • Hyperglycemia: Glucose > 250 mg/dL (Note: Once glucose is below 250 mg/dL within 12 hours after meeting inclusion criteria, the patient can then be considered for the study. This is only a temporary restriction.)
  • Hyperphosphatemia: Serum phosphorous > 5.5 mg/dL.
  • Patient with a history of metabolic abnormality in any one of the following amino acids: alanine, arginine, cysteine hydrochloride, glycine, histidine, isoleucine, leucine, lysine acetate, methionine, phenylalanine, phosphoric acid, proline, serine, threonine, tryptophan, and valine.
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Active comparator
    Group I (standard of care)

    Patients receive standard of care for septic shock.

    Other: Best Practice

  • Experimental
    Group II (early metabolic resuscitation)

    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

  • OtherBest Practice

    Receive standard of care

    Also known as: standard of care, standard therapy

  • Given Intravenous

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

06

What researchers measure

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).

    Time frame: up to 28 days or until death, whichever comes first

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Results

Posted Apr 8, 2021

Participant flow

Recruitment Period: November 2019- December 2019

Participant flow — Overall Study
MilestoneIntervention Group (EMR Solution)Controlled Group (Standard Care)
Started02
Completed02
Not completed00

Outcome measures

PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With 28-day Mortality
ParticipantsIntervention Group (EMR Solution)Controlled Group (Standard Care)
Number of Participants With 28-day Mortality00
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With 90-Day Mortality
ParticipantsIntervention Group (EMR Solution)Controlled Group (Standard Care)
Number of Participants With 90-Day Mortality00
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Hospital Mortality
ParticipantsIntervention Group (EMR Solution)Controlled Group (Standard Care)
Number of Participants With Hospital Mortality00
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With ICU Mortality
ParticipantsIntervention Group (EMR Solution)Controlled Group (Standard Care)
Number of Participants With ICU Mortality00

Adverse events

Collected over baseline, up to 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention Group (EMR Solution)———
Controlled Group (Standard Care)0/2 (0%)2/2 (100%)0/2 (0%)
Most frequent serious events
Most frequent serious events
EventIntervention Group (EMR Solution)Controlled Group (Standard Care)
HypokalemiaMetabolism and nutrition disorders—2/2

Baseline characteristics

No patients were enrolled in the Intervention group.

Age, Categorical
Age, Categorical(Participants)Intervention Group (EMR Solution)Controlled Group (Standard Care)Total
<=18 years—00
Between 18 and 65 years—11
>=65 years—11
Age, Continuous
Age, Continuous(years)Intervention Group (EMR Solution)Controlled Group (Standard Care)Total
Mean—52 (33 to 71)52 (33 to 71)
Sex: Female, Male
Sex: Female, Male(Participants)Intervention Group (EMR Solution)Controlled Group (Standard Care)Total
Female—00
Male—22
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Intervention Group (EMR Solution)Controlled Group (Standard Care)Total
Hispanic or Latino—00
Not Hispanic or Latino—22
Unknown or Not Reported—00
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Intervention Group (EMR Solution)Controlled Group (Standard Care)Total
American Indian or Alaska Native—00
Asian—00
Native Hawaiian or Other Pacific Islander—00
Black or African American—11
White—11
More than one race—00
Unknown or Not Reported—00
Region of Enrollment
Region of Enrollment(participants)Intervention Group (EMR Solution)Controlled Group (Standard Care)Total
United States—22
Cancer Type
Cancer Type(Participants)Intervention Group (EMR Solution)Controlled Group (Standard Care)Total
Gastrointestinal000
Breast000
Lung011
Cancer stage
Cancer stage(Participants)Intervention Group (EMR Solution)Controlled Group (Standard Care)Total
Metastatic Stage000
Localized/Locally advanced011
08

Study locations

1 site
  • M D Anderson Cancer Center
    Houston, Texas 77030, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 4, 2020
  • Informed consent form · Feb 4, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03895853
Responsible party
Sponsor
First posted
Mar 29, 2019
Start date
Oct 4, 2019
Primary completion
May 4, 2020
Completion
May 4, 2020
Results posted
Apr 8, 2021
Last update
Oct 29, 2024

Study contacts

Joseph L. Nates, MBA,MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Glucose

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