Mitochondrial DNA as a Biomarker of Sepsis Severity

Sepsis Clinical Trial

— MBOSS  

Official title:

Mitochondrial DNA as a Biomarker of Sepsis Severity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077672
• Other study ID #: 1605017267
• Secondary ID: R01HL055330P01HL
• Status: Completed
• Start date: February 10, 2017
• Est. completion date: December 22, 2020

Study information

• Verified date: February 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1304
• Est. completion date: December 22, 2020
• Est. primary completion date: December 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infection
• Sepsis
• Sepsis Syndrome
• Septic Shock
• Severe Sepsis
• Systemic Inflammatory Response Syndrome
• Toxemia

Locations

Country	Name	City	State
United States	New York-Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York
United States	New York Presbyterian/Weill Cornell Medicine	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Heart, Lung, and Blood Institute (NHLBI), New York Presbyterian Brooklyn Methodist Hospital, New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

Nakahira K, Kyung SY, Rogers AJ, Gazourian L, Youn S, Massaro AF, Quintana C, Osorio JC, Wang Z, Zhao Y, Lawler LA, Christie JD, Meyer NJ, Mc Causland FR, Waikar SS, Waxman AB, Chung RT, Bueno R, Rosas IO, Fredenburgh LE, Baron RM, Christiani DC, Hunninghake GM, Choi AM. Circulating mitochondrial DNA in patients in the ICU as a marker of mortality: derivation and validation. PLoS Med. 2013 Dec;10(12):e1001577; discussion e1001577. doi: 10.1371/journal.pmed.1001577. Epub 2013 Dec 31. — View Citation

Torio CM, Moore BJ. National Inpatient Hospital Costs: The Most Expensive Conditions by Payer, 2013. 2016 May. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #204. Available from http://www.ncbi.nlm.nih.gov/books/NBK368492/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Mortality	All-Cause	60 Days
Secondary	Association with severity of illness as determined by qSOFA Score	qSOFA	3 Days
Secondary	Association with severity of illness severity of illness as determined by MEDS Score	MEDS Score	3 Days
Secondary	Association with severity of illness as determined by SOFA Score	SOFA Score	3 Days
Secondary	Need for Supportive Measures	NIPPV, Mechanical Ventilation, Vasopressors, CVVHD, iNO, ECMO	Up to 60 Days
Secondary	ICU-Free Days	Number of days free from ICU Admission	28 Days
Secondary	Triage Decision	If the patient was discharged home or admitted to the floor, a step-down unit, or an ICU	3 Days