An observational study in Sepsis Syndrome, Sepsis and Severe Sepsis, sponsored by Weill Medical College of Cornell University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-24.
Sponsored by Weill Medical College of Cornell University · Observational
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.
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.
1,894 studies on the registry are indexed under Sepsis; 458 are open to participants now.
This study's enrollment of 1,304 is above the median of 160 across 929 observational studies indexed under Sepsis.
Browse Sepsis studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
We intend to study patients presenting to the NYP-Weill Cornell Medicine Emergency Department and the NYP-Brooklyn Methodist Emergency Department.
Exclusion Criteria:
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
All-Cause
Time frame: 60 Days
Association with severity of illness as determined by qSOFA Score
qSOFA
Time frame: 3 Days
Association with severity of illness severity of illness as determined by MEDS Score
MEDS Score
Time frame: 3 Days
Association with severity of illness as determined by SOFA Score
SOFA Score
Time frame: 3 Days
Need for Supportive Measures
NIPPV, Mechanical Ventilation, Vasopressors, CVVHD, iNO, ECMO
Time frame: Up to 60 Days
ICU-Free Days
Number of days free from ICU Admission
Time frame: 28 Days
Triage Decision
If the patient was discharged home or admitted to the floor, a step-down unit, or an ICU
Time frame: 3 Days
Plan to share: Yes — Upon reasonable request, de-identified participant data will be able available to individuals six-months after publication of all data.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University