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Mitochondrial DNA as a Biomarker of Sepsis Severity (MBOSS)

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ClinicalTrials.gov Identifier: NCT03077672
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : October 22, 2019
Sponsor:
Collaborators:
New York Presbyterian Hospital
New York Methodist Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:

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.


Condition or disease
Sepsis Syndrome Sepsis Severe Sepsis Septic Shock Infection

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mitochondrial DNA as a Biomarker of Sepsis Severity
Actual Study Start Date : February 10, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort
NYP-WCM
The NYP-WCM cohort will consist of patients presenting to the NewYork-Presbyterian/Weill Cornell Medicine Emergency Department with suspected sepsis.
NYP-BMH
The NYP-BMH cohort will consist of patients presenting to the NewYork-Presbyterian Brooklyn Methodist Hospital Emergency Department with suspected sepsis.



Primary Outcome Measures :
  1. Hospital Mortality [ Time Frame: 60 Days ]
    All-Cause


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Plasma, Leukocyte Pellet, Mitochondrial DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We intend to study patients presenting to the NYP-Weill Cornell Medicine Emergency Department and the NYP-Brooklyn Methodist Emergency Department.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077672


Contacts
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Contact: John S Harrington, MD 212-746-1074 jsh9012@nyp.org
Contact: Edward J Schenck, MD 646-962-2333 ejs9005@med.cornell.edu

Locations
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United States, New York
New York-Presbyterian Brooklyn Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Paris Ayana dattilo, RN    718-780-5040    pad9011@nyp.org   
New York Presbyterian/Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: John S Harrington, MD    212-746-1074    jsh9012@nyp.org   
Contact: Edward J Schenck, MD    646-962-2333    ejs9005@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
New York Presbyterian Hospital
New York Methodist Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Augustine MK Choi, MD Weill Cornell Medicine

Publications:
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03077672     History of Changes
Other Study ID Numbers: 1605017267
R01HL055330 ( U.S. NIH Grant/Contract )
P01HL108801 ( U.S. NIH Grant/Contract )
KL2TR000458-10 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon reasonable request, de-identified participant data will be able available to individuals six-months after publication of all data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
Mitochondrial DNA
Lactate
Mortality
Emergency Department
Intensive Care Unit
Triage
Organ Dysfunction
Biomarker
Prognosis
Additional relevant MeSH terms:
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Sepsis
Toxemia
Systemic Inflammatory Response Syndrome
Infection
Inflammation
Pathologic Processes
Shock