Mitochondrial DNA as a Biomarker of Sepsis Severity

Completed

• Conditions: Severe Sepsis; Infection; Sepsis Syndrome; Sepsis; Septic Shock

• Registration Number: NCT03077672
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-02-10
• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-13
• Primary Completion: 2020-12-22
• Study Completion: 2020-12-22
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1304

Inclusion Criteria

• Adults presenting to the Emergency Department with suspected sepsis.

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Exclusion Criteria

• Pregnancy.
• Patients with limitations of care at the time of specimen collection.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital Mortality	60 Days	All-Cause

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

New York-Presbyterian Brooklyn Methodist Hospital; 🇺🇸 Brooklyn, New York, United States

New York Presbyterian/Weill Cornell Medicine; 🇺🇸 New York, New York, United States