Mitochondrial DNA as a Biomarker of Sepsis Severity

NCT03077672 | Completed

• 3 other identifiers: 1605017267R01HL055330P01HL108801
• Study Type: observational
• Target: 1,304
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Mitochondrial DNA; Lactate; Mortality; Emergency Department; Intensive Care Unit; Triage; Organ Dysfunction; Biomarker; Prognosis

Outcome Measures

Primary Outcomes (1)

• Hospital Mortality

  All-Cause

  60 Days

Secondary Outcomes (6)

• Association with severity of illness as determined by qSOFA Score

  3 Days

• Association with severity of illness severity of illness as determined by MEDS Score

  3 Days

• Association with severity of illness as determined by SOFA Score

  3 Days

• Need for Supportive Measures

  Up to 60 Days

• ICU-Free Days

  28 Days

Study Arms (2)

NYP-WCM

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

NYP-BMH

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We intend to study patients presenting to the NYP-Weill Cornell Medicine Emergency Department and the NYP-Brooklyn Methodist Emergency Department.

You may qualify if:

• Adults presenting to the Emergency Department with suspected sepsis.

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• New York Presbyterian Hospital: collaborator
• New York Presbyterian Brooklyn Methodist Hospital: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

New York-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

New York Presbyterian/Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (2)

• 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/

  PMID: 27359025 BACKGROUND

• 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.

  PMID: 24391478 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Leukocyte Pellet, Mitochondrial DNA

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Sepsis; Shock, Septic; Infections; Emergencies

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Study Officials

• John Harrington, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 13, 2017
• Study Start: February 10, 2017
• Primary Completion: December 22, 2020
• Study Completion: December 22, 2020
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2)