MBOSS: Mitochondrial DNA as a Biomarker of Sepsis Severity

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03077672

Collaborator

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

600

Enrollment

Locations

70.6

Anticipated Duration (Months)

300

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Mitochondrial DNA as a Biomarker of Sepsis Severity

Actual Study Start Date :

Feb 10, 2017

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Hospital Mortality [60 Days]
All-Cause

Secondary Outcome Measures

Association with severity of illness as determined by qSOFA Score [3 Days]
qSOFA
Association with severity of illness severity of illness as determined by MEDS Score [3 Days]
MEDS Score
Association with severity of illness as determined by SOFA Score [3 Days]
SOFA Score
Need for Supportive Measures [Up to 60 Days]
NIPPV, Mechanical Ventilation, Vasopressors, CVVHD, iNO, ECMO
ICU-Free Days [28 Days]
Number of days free from ICU Admission
Triage Decision [3 Days]
If the patient was discharged home or admitted to the floor, a step-down unit, or an ICU

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York-Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York	United States	11215
2	New York Presbyterian/Weill Cornell Medicine	New York	New York	United States	10065