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Sepsis | Observational Study of Sepsis and Pneumonia to Develop Diagnostic Tests

Sepsis research study

What is the primary objective of this study?

We propose to develop novel diagnostic tests for severe sepsis and community acquired pneumonia (CAP). This program, entitled Community Acquired Pneumonia Duke University Medical Center, Durham, NC; Henry Ford Hospital, Detroit, MI; Eli Lilly and Company, Indianapolis, IN; Indiana Centers for Applied Protein Sciences, Indianapolis, IN; and ProSanos Corp., La Jolla, CA. In the United States, Community Acquired Pneumonia is the sixth leading cause of death and the number one cause of death from infectious diseases. Of the 5.6 million annual cases of CAP, 1.1 million require hospitalization for intensive therapy. Sepsis, commonly known as blood poisoning or bloodstream infection, is the tenth leading cause of death in the US and the number one cause of death in non-cardiac intensive care units. Incidence of sepsis is increasing by 9% each year and mortality rates vary between 25 and 50%. Cost to the US healthcare system exceeds $20 billion each year. In patients with suspected sepsis or early CAP, rapid identification of patients who will develop severe sepsis or CAP is critical for effective management and positive outcome. The CAPSOD study is designed to identify novel tests for early diagnosis of severe sepsis and CAP. When performed in patients at the earliest stages of disease, these tests will have prognostic value, rapidly identifying those who will have poor outcomes or complicated courses. CAPSOD will prospectively enroll patients with sepsis and CAP at Duke University Medical Center and Henry Ford Hospital. The study will use advanced bioinformatic, metabolomic, proteomic and mRNA sequencing technologies to identify specific protein changes, or biomarkers, in patient blood samples that predict outcome in sepsis and CAP. Development of biomarker-based tests will permit patient selection for appropriate disposition, such as the intensive care unit, and use of intensive medical therapies, thereby reducing mortality and increasing effectiveness of resource allocation.

Who is eligible to participate?

Inclusion Criteria: 1. Patient has known or acute infection or suspected infection AND patient must meet at least 2 of the following 4 criteria to be enrolled 1. A core temperature of >= 38°C (100.4°F) or <= 36°C (96.8°F) 2. Patients > 18 years of age, Heart rate of >= 90 beats/min Patients 13-18 years of age, Heart rate of >= 110 beats/min Patients 6-12 years of age, Heart rate of >= 130 beats/min 3. Patients > 18 years of age, Respiratory rate of >= 20 breaths/min Patients 13-18 years of age, Respiratory rate of >= 14 breaths/min Patients 6-12 years of age, Respiratory rate of >= 18 breaths/min OR PaCO2 of <= 32 mm Hg OR Use of Mechanical Ventilation for an acute respiratory process 4. Patients > 18 years of age, White cell count >= 12,000/mm3 or <= 4,000/mm3 Patients 13-18 years of age, White cell count >= 11,000/mm3 or <= 4,500/mm3 Patients 6-12 years of age, White cell count >= 13,500/mm3 or <= 4,500/mm3 OR A differential count showing > 10% immature neutrophils Exclusion Criteria: 1. Patient is less than 6 years of age. 2. Patient is not expected to survive 28 days because of uncorrectable medical condition (apart from pneumonia or sepsis), such as poorly controlled neoplasm or other end-stage disease, or patient has active DNR order 3. Human immunodeficiency virus (HIV) infection with a last known CD4 count of <50 mm3 4. Acute presence of a cerebral vascular event, active gastrointestinal hemorrhage, seizure (acute episode), drug overdose, burn injury, trauma 5. Patient is pregnant

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Sepsis

Septicemia

Sepsis Syndrome

Shock, Septic

Community Acquired Pneumonia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1Emergency department patients with sepsis

Study Status

Unknown status

Start Date: December 2005

Completed Date: July 2010

Phase:

Type: Observational

Design:

Primary Outcome: Death

Secondary Outcome: Time to death

Study sponsors, principal investigator, and references

Principal Investigator: Stephen F Kingsmore, MB ChB BAO

Lead Sponsor: National Center for Genome Resources

Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)

More information:https://clinicaltrials.gov/show/NCT00258869

Perlee LT, Christiansen J, Dondero R, Grimwade B, Lejnine S, Mullenix M, Shao W, Sorette M, Tchernev VT, Patel DD, Kingsmore SF. Development and standardization of multiplexed antibody microarrays for use in quantitative proteomics. Proteome Sci. 2004 Dec 15;2:9. doi: 10.1186/1477-5956-2-9. eCollection 2004.

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