Application of Stimulated Immune Response Change to Predict Outcome of Patient With Severe Sepsis

NCT02887274 | Unknown

• 1 other identifier: CMRPG8B1073
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Persistence of a marked compensatory anti-inflammatory innate immune response after an insult is termed immunoparalysis. There is no biomarker available to determine the immune status of patient. Thus, the need for early and definite diagnosis of immune status of patient with sepsis, as well as the identification of patients at risk of evolving with severe organ dysfunctions, is crucial. Most important of all, speed is the key to survival. Therefore, it of crucial importance to identify which patient characteristic determines the poor prognosis. Early intervention can improve the prognosis. Investigators foresee an urgent need to identify predictors for mortality in severe sepsis, including clinical factors or immune status. Recently, the PIRO model has been proposed as a way of stratifying septic patients according to their Predisposing condition, the severity of Infection, the Response to therapy and the degree of Organ dysfunction. The immune status may be associated with above model. However, there is paucity data addressing this issue. In this study, investigators will also analyze the progression of patient condition during treatment and the associated immune status change. In the future, Investigators hope the determination of immune status may contribute to this model of classification rather than just being used as prognostic markers. Despite the advances in the knowledge of the basic processes that trigger and sustain the systemic inflammatory response in sepsis, the search for a "magic bullet" to treat this syndrome has been frustrating. The incidence of severe sepsis and septic shock still remains quite high, as does its mortality, which has decreased very little over the past decades.

Conditions

Systemic Inflammatory Response Syndrome (SIRS); Sepsis; Severe Sepsis; Septic Shock; Multiple Organ Failure

Keywords

Systemic Inflammatory Response Syndrome (SIRS); Sepsis; Severe Sepsis; Septic shock; Multiple organ failure

Outcome Measures

Primary Outcomes (1)

• The diagnostic accuracy of stimulated immune response for predicting mortality

  4 weeks, up to 24 weeks

Secondary Outcomes (1)

• Whether trend change in stimulated immune response more useful for prediction mortality

  4 weeks, up to 24 weeks

Other Outcomes (1)

• Whether stimulated immune response can predict patients at risk of evolving with severe organ dysfunctions

  4 weeks, up to 24 weeks

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

The study will be conducted at Kaohsiung Chang Gung Memorial Hospital. All adult patients presenting with sepsis or severe sepsis will be enrolled on admission to medical intensive units (total 34 beds). Sepsis and severe sepsis are defined as American College of Chest Physicians/Society of Critical Care Medicine consensus criteria for sepsis syndromes.

You may qualify if:

• Severe sepsis
• Septic shock

You may not qualify if:

• Patients are \< 18 yrs
• Patients are immunocompromised (treatment with corticosteroids \>1 mg/kg equivalent prednisone)
• Bone marrow or organ transplant recipients,
• Leucopenia \[white blood cells count\< 109/L\] or neutropenia \[polymorphonuclear granulocyte count \<0.5 109/L\]
• Hematologic malignancy

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Related Publications (10)

• Frazier WJ, Hall MW. Immunoparalysis and adverse outcomes from critical illness. Pediatr Clin North Am. 2008 Jun;55(3):647-68, xi. doi: 10.1016/j.pcl.2008.02.009.

  PMID: 18501759 RESULT

• Hall MW, Knatz NL, Vetterly C, Tomarello S, Wewers MD, Volk HD, Carcillo JA. Immunoparalysis and nosocomial infection in children with multiple organ dysfunction syndrome. Intensive Care Med. 2011 Mar;37(3):525-32. doi: 10.1007/s00134-010-2088-x. Epub 2010 Dec 10.

  PMID: 21153402 RESULT

• Neveu H, Kleinknecht D, Brivet F, Loirat P, Landais P. Prognostic factors in acute renal failure due to sepsis. Results of a prospective multicentre study. The French Study Group on Acute Renal Failure. Nephrol Dial Transplant. 1996 Feb;11(2):293-9. doi: 10.1093/oxfordjournals.ndt.a027256.

  PMID: 8700363 RESULT

• Vincent JL, Abraham E, Annane D, Bernard G, Rivers E, Van den Berghe G. Reducing mortality in sepsis: new directions. Crit Care. 2002 Dec;6 Suppl 3(Suppl 3):S1-18. doi: 10.1186/cc1860. Epub 2002 Dec 5.

  PMID: 12720570 RESULT

• Marshall JC, Charbonney E, Gonzalez PD. The immune system in critical illness. Clin Chest Med. 2008 Dec;29(4):605-16, vii. doi: 10.1016/j.ccm.2008.08.001.

  PMID: 18954696 RESULT

• Sakr Y, Burgett U, Nacul FE, Reinhart K, Brunkhorst F. Lipopolysaccharide binding protein in a surgical intensive care unit: a marker of sepsis? Crit Care Med. 2008 Jul;36(7):2014-22. doi: 10.1097/CCM.0b013e31817b86e3.

  PMID: 18552695 RESULT

• Shiramizo SC, Marra AR, Durao MS, Paes AT, Edmond MB, Pavao dos Santos OF. Decreasing mortality in severe sepsis and septic shock patients by implementing a sepsis bundle in a hospital setting. PLoS One. 2011;6(11):e26790. doi: 10.1371/journal.pone.0026790. Epub 2011 Nov 3.

  PMID: 22073193 RESULT

• Nguyen HB, Corbett SW, Steele R, Banta J, Clark RT, Hayes SR, Edwards J, Cho TW, Wittlake WA. Implementation of a bundle of quality indicators for the early management of severe sepsis and septic shock is associated with decreased mortality. Crit Care Med. 2007 Apr;35(4):1105-12. doi: 10.1097/01.CCM.0000259463.33848.3D.

  PMID: 17334251 RESULT

• Phua J, Koh Y, Du B, Tang YQ, Divatia JV, Tan CC, Gomersall CD, Faruq MO, Shrestha BR, Gia Binh N, Arabi YM, Salahuddin N, Wahyuprajitno B, Tu ML, Wahab AY, Hameed AA, Nishimura M, Procyshyn M, Chan YH; MOSAICS Study Group. Management of severe sepsis in patients admitted to Asian intensive care units: prospective cohort study. BMJ. 2011 Jun 13;342:d3245. doi: 10.1136/bmj.d3245.

  PMID: 21669950 RESULT

• Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. doi: 10.1097/01.CCM.0000050454.01978.3B.

  PMID: 12682500 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum immunological biomarkers including cytokines, blood cell counts, and biochemistry profiles.

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Sepsis; Shock, Septic; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Infections

Study Officials

• Wen-Feng Fang, M.D

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheryl Huang, Bachelor

CONTACT

886077317123; cheryl60286@gmail.com

Study Design

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

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: September 2, 2016
• Study Start: July 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 7, 2018

Record last verified: 2018-08

Locations

TW (1)