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Completed

NCT Number: NCT03077672

Mitochondrial DNA as a Biomarker of Sepsis Severity

Mitochondria are organelles (a specialized subunit of a cell) responsible for providing cells with energy. For reasons not yet understood, mitochondria will release their DNA into blood in response to cellular injury or cell death.

With a simple blood draw, investigators can measure the amount of mitochondrial DNA in a patient's blood.

The investigators' hypothesis, is that mitochondrial DNA can be used as a surrogate marker of cellular injury to predict patient outcomes. The investigators intend to test their hypothesis by measuring mitochondrial DNA in adult patients presenting to the Emergency Department with sepsis (a life-threatening condition due to an infection) and observing their hospital course.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

New York-Presbyterian Brooklyn Methodist Hospital, Brooklyn, New York, United States

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About this study

Despite the advances of modern medicine, sepsis persists as one of the leading causes of death in the United States and poses a significant burden on U.S. health care, accounting for more than $24 billion of total hospital costs in 2013. The high mortality and cost of treating sepsis at least partially stems from the consequences of delayed diagnosis. Unfortunately, this delay is attributable to the broad clinical manifestations of the syndrome and the absence of a specific test for sepsis.

Realizing this, The Society of Critical Care Medicine and the European Society of Intensive Care Medicine have released guidelines emphasizing the need for diagnostic approaches aimed at the early detection of sepsis. The hope is that early recognition will allow for more aggressive upfront management thereby improving patient outcomes.

In 2013, Nakahira et al showed that circulating cell-free mitochondrial DNA levels are associated with sepsis and mortality in patients admitted to the ICU. In contrast to that study, the purpose here is to determine whether circulating cell-free mitochondrial DNA and other biomarkers are associated with the severity of sepsis and 28-day mortality in patients presenting to the ED with sepsis.

To accomplish this task, the investigators intend to prospectively collect specimens from patients presenting to NYP-Weill Cornell and NYP-Brooklyn Methodist with suspected sepsis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults presenting to the Emergency Department with suspected sepsis.

Exclusion criteria

  • Pregnancy.
  • Patients with limitations of care at the time of specimen collection.

Treatment and study plan

Primary outcomes

  1. Hospital Mortality

    Time frame: 60 Days

    All-Cause

Secondary outcomes

  1. Association with severity of illness as determined by qSOFA Score

    Time frame: 3 Days

    qSOFA

  2. Association with severity of illness severity of illness as determined by MEDS Score

    Time frame: 3 Days

    MEDS Score

  3. Association with severity of illness as determined by SOFA Score

    Time frame: 3 Days

    SOFA Score

  4. Need for Supportive Measures

    Time frame: Up to 60 Days

    NIPPV, Mechanical Ventilation, Vasopressors, CVVHD, iNO, ECMO

  5. ICU-Free Days

    Time frame: 28 Days

    Number of days free from ICU Admission

  6. Triage Decision

    Time frame: 3 Days

    If the patient was discharged home or admitted to the floor, a step-down unit, or an ICU

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • New York Presbyterian Brooklyn Methodist Hospital
  • New York Presbyterian Hospital

Registry information

Acronym: MBOSS

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 13, 2017
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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