Mitochondrial DNA as a Biomarker of Sepsis Severity

NCT ID: NCT03077672

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1304 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-10
• Study Completion Date: 2020-12-22

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.

Conditions

Sepsis Syndrome; Sepsis; Severe Sepsis; Septic Shock; Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NYP-WCM

The NYP-WCM cohort will consist of patients presenting to the NewYork-Presbyterian/Weill Cornell Medicine Emergency Department with suspected sepsis.

No interventions assigned to this group

NYP-BMH

The NYP-BMH cohort will consist of patients presenting to the NewYork-Presbyterian Brooklyn Methodist Hospital Emergency Department with suspected sepsis.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York Presbyterian Hospital

OTHER

Sponsor Role: collaborator

New York Presbyterian Brooklyn Methodist Hospital

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Harrington, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

New York-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, United States

New York Presbyterian/Weill Cornell Medicine

New York, New York, United States

Countries

United States

References

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/

Reference Type: BACKGROUND

PMID: 27359025 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24391478 (View on PubMed)

Other Identifiers

R01HL055330

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P01HL108801

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1605017267

Identifier Type: -

Identifier Source: org_study_id