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
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|
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.
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|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|
The NYP-WCM cohort will consist of patients presenting to the NewYork-Presbyterian/Weill Cornell Medicine Emergency Department with suspected sepsis.
The NYP-BMH cohort will consist of patients presenting to the NewYork-Presbyterian Brooklyn Methodist Hospital Emergency Department with suspected sepsis.
- Hospital Mortality [ Time Frame: 60 Days ]All-Cause
- Association with severity of illness as determined by qSOFA Score [ Time Frame: 3 Days ]qSOFA
- Association with severity of illness severity of illness as determined by MEDS Score [ Time Frame: 3 Days ]MEDS Score
- Association with severity of illness as determined by SOFA Score [ Time Frame: 3 Days ]SOFA Score
- Need for Supportive Measures [ Time Frame: Up to 60 Days ]NIPPV, Mechanical Ventilation, Vasopressors, CVVHD, iNO, ECMO
- ICU-Free Days [ Time Frame: 28 Days ]Number of days free from ICU Admission
- 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
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
|Contact: John S Harrington, MDemail@example.com|
|Contact: Edward J Schenck, MDfirstname.lastname@example.org|
|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 email@example.com|
|New York Presbyterian/Weill Cornell Medicine||Recruiting|
|New York, New York, United States, 10065|
|Contact: John S Harrington, MD 212-746-1074 firstname.lastname@example.org|
|Contact: Edward J Schenck, MD 646-962-2333 email@example.com|
|Principal Investigator:||Augustine MK Choi, MD||Weill Cornell Medicine|