Mitochondrial DNA as a Biomarker of Sepsis Severity
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Hospital, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/6/2019 |
| Start Date: | February 10, 2017 |
| End Date: | December 31, 2019 |
| Contact: | John S Harrington, MD |
| Email: | jsh9012@nyp.org |
| Phone: | 212-746-1074 |
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.
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.
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.
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.
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.
We found this trial at
2
sites
425 East 61st Street
New York, New York 10065
New York, New York 10065
Phone: 212-746-1074
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263 7th Avenue
Brooklyn, New York 11215
Brooklyn, New York 11215
Phone: 718-780-5040
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