Studies of Blood DNA in Patients With Severe Infection DYNAMICS

NCT01355042 | Completed

• 1 other identifier: CIHR-220268
• Study Type: observational
• Target: 792
• Locations: 1 country
• Sites: 6

Brief Summary

Severe sepsis (ie. life-threatening infections) is triggered by harmful microorganisms or their toxins in the blood or tissues. These harmful agents damage the lining of blood vessels which can lead to inflammation, blood clot formation, and vessel obstruction. In Canada, there are approximately 90,000 patients with severe sepsis each year. Of these, 30% to 50% will die. The identification of highly reliable outcome predictors in severe sepsis patients is important for several reasons including: to help describe the severity of sepsis, to classify patients for enrollment in clinical studies, and to monitor a patient's response to treatment and procedures. In the investigators lab, the investigators examined the incremental usefulness of adding multiple biomarkers to clinical scoring systems for predicting ICU mortality in patients with severe sepsis. In a preliminary study of 80 patients with sepsis, the investigators found that high levels of plasma DNA predicted ICU death better than any other clinical or biological factor. In this grant, the investigators propose to confirm these findings in an external group of 400 patients in a blinded fashion. The investigators also plan to study how plasma DNA levels change over time and whether high plasma DNA levels can be used to distinguish sepsis from other critically ill conditions. For this the investigators will compare the investigators septic patients to a cohort of 600 patients in the ICU with other conditions. The investigators believe this research has the potential to significantly improve the management and treatment of septic patients.

Conditions

Sepsis; Shock; Trauma

Study Arms (2)

Severe Sepsis and Septic Shock

Other Critical Ill with or without Shock

Severe Trauma, Neurological Injury, Other Shock (not Septic)

Eligibility Criteria

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

Study Population

Patients admitted to academic intensive care units

You may qualify if:

• admitted to an intensive care unit with either sepsis or other critical illness in previous 24 hrs

You may not qualify if:

• less than 18 yrs old
• not expected to survive 72 hrs

Sponsors & Collaborators

• Alison Fox-Robichaud: lead

Study Sites (6)

Alberta Health Services -- Foothills Hospital

Calgary, Alberta, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Hamilton Health Sciences: General Site

Hamilton, Ontario, Canada

Location

St Joseph's Health Care

Hamilton, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Centre Hospitalier de l'Universite Laval

Laval, Quebec, Canada

Location

Related Publications (2)

• Jackson Chornenki NL, Coke R, Kwong AC, Dwivedi DJ, Xu MK, McDonald E, Marshall JC, Fox-Robichaud AE, Charbonney E, Liaw PC. Comparison of the source and prognostic utility of cfDNA in trauma and sepsis. Intensive Care Med Exp. 2019 May 22;7(1):29. doi: 10.1186/s40635-019-0251-4.

  PMID: 31119471 DERIVED

• Grin PM, Dwivedi DJ, Chathely KM, Trigatti BL, Prat A, Seidah NG, Liaw PC, Fox-Robichaud AE. Low-density lipoprotein (LDL)-dependent uptake of Gram-positive lipoteichoic acid and Gram-negative lipopolysaccharide occurs through LDL receptor. Sci Rep. 2018 Jul 12;8(1):10496. doi: 10.1038/s41598-018-28777-0.

  PMID: 30002483 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Sepsis; Shock; Wounds and Injuries

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia Liaw, PhD

  Thrombosis and Atherosclerosis Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 17, 2011
• Study Start: November 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2016
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

CA (6)