STUDY00015328: Sepsis Endotypes

NCT03146546 | Enrolling By Invitation

• 1 other identifier: 7188
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the utility of biomarkers measured in blood and body fluid (stool, saliva, tracheal aspirate) when combined with clinical data, for predicting sepsis phenotypes that are associated with poor clinical outcomes. We hypothesize that resistin is a biomarker which provides critical prognostic information when used in conjunction with standard clinical data, in patients with sepsis and septic shock.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• death and chronic critical illness

  The primary outcome is a composite binary variable consisting of early death and chronic critical illness which we will determine on or before day 14 after sepsis onset.

  5 years for completion of study, 1 year follow up per patient enrolled

Secondary Outcomes (5)

• The expression of BPGM and AP2 transcripts

  5 years for completion of study, 1 year follow up per patient enrolled

• Clinical variables

  5 years for completion of study, 1 year follow up per patient enrolled

• Acute Physiology and Chronic Health Evaluation II Score

  5 years for completion of study, 1 year follow up per patient enrolled

• Sequential Organ Failure Assessment

  5 years for completion of study, 1 year follow up per patient enrolled

• Muscle measurements

  5 years for completion of study, 1 year follow up per patient enrolled

Study Arms (2)

Sepsis

Patients with sepsis as defined by the Sepsis-3 criteria

Control

Patients without sepsis, as defined by the Sepsis-3 criteria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in the intensive care unit (ICU) who meet critera for sepsis, as defined by the Sepsis-3 criteria and who are not excluded by any of the exclusion factors listed in the "Eligibility Criteria".

You may qualify if:

• Adults (age ≥ 18 )
• gender: male or female
• Cognitively intact or impaired patients, given that sepsis may cause a certain degree of cognitive dysfunction in patients. All patients in the control group (no sepsis) will be cognitively intact
• Clinical suspicion for sepsis (except for control/comparison group for whom infection is NOT a current concern)

You may not qualify if:

• Patients with hematologic malignancies
• Pregnant women
• Patient/surrogate is not fluent in English and no translation services are available
• Long-term immunosuppressive therapy
• Prisoner

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (8)

• Kovach MA, Standiford TJ. The function of neutrophils in sepsis. Curr Opin Infect Dis. 2012 Jun;25(3):321-7. doi: 10.1097/QCO.0b013e3283528c9b.

  PMID: 22421753 BACKGROUND

• Stephan F, Yang K, Tankovic J, Soussy CJ, Dhonneur G, Duvaldestin P, Brochard L, Brun-Buisson C, Harf A, Delclaux C. Impairment of polymorphonuclear neutrophil functions precedes nosocomial infections in critically ill patients. Crit Care Med. 2002 Feb;30(2):315-22. doi: 10.1097/00003246-200202000-00009.

  PMID: 11889301 BACKGROUND

• Delano MJ, Thayer T, Gabrilovich S, Kelly-Scumpia KM, Winfield RD, Scumpia PO, Cuenca AG, Warner E, Wallet SM, Wallet MA, O'Malley KA, Ramphal R, Clare-Salzer M, Efron PA, Mathews CE, Moldawer LL. Sepsis induces early alterations in innate immunity that impact mortality to secondary infection. J Immunol. 2011 Jan 1;186(1):195-202. doi: 10.4049/jimmunol.1002104. Epub 2010 Nov 24.

  PMID: 21106855 BACKGROUND

• Cummings CJ, Martin TR, Frevert CW, Quan JM, Wong VA, Mongovin SM, Hagen TR, Steinberg KP, Goodman RB. Expression and function of the chemokine receptors CXCR1 and CXCR2 in sepsis. J Immunol. 1999 Feb 15;162(4):2341-6.

  PMID: 9973513 BACKGROUND

• Macdonald SP, Stone SF, Neil CL, van Eeden PE, Fatovich DM, Arendts G, Brown SG. Sustained elevation of resistin, NGAL and IL-8 are associated with severe sepsis/septic shock in the emergency department. PLoS One. 2014 Oct 24;9(10):e110678. doi: 10.1371/journal.pone.0110678. eCollection 2014.

  PMID: 25343379 BACKGROUND

• Koch A, Gressner OA, Sanson E, Tacke F, Trautwein C. Serum resistin levels in critically ill patients are associated with inflammation, organ dysfunction and metabolism and may predict survival of non-septic patients. Crit Care. 2009;13(3):R95. doi: 10.1186/cc7925. Epub 2009 Jun 19.

  PMID: 19545363 BACKGROUND

• Sunden-Cullberg J, Nystrom T, Lee ML, Mullins GE, Tokics L, Andersson J, Norrby-Teglund A, Treutiger CJ. Pronounced elevation of resistin correlates with severity of disease in severe sepsis and septic shock. Crit Care Med. 2007 Jun;35(6):1536-42. doi: 10.1097/01.CCM.0000266536.14736.03.

  PMID: 17452927 BACKGROUND

• Singbartl K, Miller L, Ruiz-Velasco V, Kellum JA. Reversal of Acute Kidney Injury-Induced Neutrophil Dysfunction: A Critical Role for Resistin. Crit Care Med. 2016 Jul;44(7):e492-501. doi: 10.1097/CCM.0000000000001472.

  PMID: 26646460 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Anthony Bonavia, M.D.

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: May 10, 2017
• Study Start: August 6, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)