Immune Profile of Patients With Sepsis

NCT04163705 | Unknown DMC

• 1 other identifier: Hospital El Cruce
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The immune response can acquire different profiles (proinflammatory and anti-inflammatory response) depending on the activating agent.The objective of this study is to compare the immunological profile in patients with severe sepsis and positive blood cultures.

Conditions

Sepsis, Severe

Keywords

Multiple organ dysfunctions

Outcome Measures

Primary Outcomes (2)

• Comparison of the proinflammatory response.

  Plasma level comparison of: TNF-alpha, IL-6 and IL-1 between both groups, by flow cytometry.

  Six months

• Comparison of the anti-inflammatory response

  Plasma level comparison of: TNF-alpha receptor, INF-gamma and IL-10 between both groups, by flow cytometry.

  Six months

Secondary Outcomes (2)

• Mortality comparison

  Six months

• SOFA score comparison

  Six months

Study Arms (2)

Gram negative

The presence of one or more positive samples will be considered positive blood cultures. Patients with severe sepsis will be enrolled prospectively and consecutively. Some of the blood used for blood culture samples will be processed for the study (sample 0). The plasma will be stored at -80 ° for later analysis. A routine clinical and laboratory database will be completed. Only patients who have positive blood cultures will be randomized according to their result in: sepsis by Gram positive or Gram negative.

Diagnostic Test: blood sample collection

Gram positive

The presence of one or more positive samples will be considered positive blood cultures. Patients with severe sepsis will be enrolled prospectively and consecutively. Some of the blood used for blood culture samples will be processed for the study (sample 0). The plasma will be stored at -80 ° for later analysis. A routine clinical and laboratory database will be completed. Only patients who have positive blood cultures will be randomized according to their result in: sepsis by Gram positive or Gram negative.

Diagnostic Test: blood sample collection

Interventions

blood sample collection DIAGNOSTIC_TEST

Routine Laboratory Analysis

Gram negative; Gram positive

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with severe sepsis and positive blood cultures will be included prospectively, within 24 hours of diagnosis of sepsis.

You may not qualify if:

• VIH immunosuppression Autoimmune disease Neoplasm Pregnant women Cirrhosis Bone Marrow Disease Malnutrition.

Sponsors & Collaborators

• Hospital El Cruce: lead

Related Publications (9)

• Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.

  PMID: 23353941 BACKGROUND

• Gotts JE, Matthay MA. Sepsis: pathophysiology and clinical management. BMJ. 2016 May 23;353:i1585. doi: 10.1136/bmj.i1585.

  PMID: 27217054 BACKGROUND

• Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.

  PMID: 23480440 BACKGROUND

• Zeni F, Vindimian M, Pain P, Gery P, Tardy B, Bertrand JC. Antiinflammatory and proinflammatory cytokines in patients with severe sepsis. J Infect Dis. 1995 Oct;172(4):1171-2. doi: 10.1093/infdis/172.4.1171. No abstract available.

  PMID: 7561209 BACKGROUND

• Endo S, Inada K, Inoue Y, Kuwata Y, Suzuki M, Yamashita H, Hoshi S, Yoshida M. Two types of septic shock classified by the plasma levels of cytokines and endotoxin. Circ Shock. 1992 Dec;38(4):264-74.

  PMID: 1292890 BACKGROUND

• Annane D, Bellissant E, Cavaillon JM. Septic shock. Lancet. 2005 Jan 1-7;365(9453):63-78. doi: 10.1016/S0140-6736(04)17667-8.

  PMID: 15639681 BACKGROUND

• Minasyan H. Sepsis and septic shock: Pathogenesis and treatment perspectives. J Crit Care. 2017 Aug;40:229-242. doi: 10.1016/j.jcrc.2017.04.015. Epub 2017 Apr 18.

  PMID: 28448952 BACKGROUND

• Guenter CA, Hinshaw LB. Comparison of septic shock due to gram-negative and gram-positive organisms. Proc Soc Exp Biol Med. 1970 Jul;134(3):780-3. doi: 10.3181/00379727-134-34882. No abstract available.

  PMID: 4988179 BACKGROUND

• Janols H, Bergenfelz C, Allaoui R, Larsson AM, Ryden L, Bjornsson S, Janciauskiene S, Wullt M, Bredberg A, Leandersson K. A high frequency of MDSCs in sepsis patients, with the granulocytic subtype dominating in gram-positive cases. J Leukoc Biol. 2014 Nov;96(5):685-93. doi: 10.1189/jlb.5HI0214-074R. Epub 2014 Jun 13.

  PMID: 24929004 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

The plasma will be stored at -80 ° for later analysis

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Nestor Pistillo, MD

  Hospital El Cruce

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nestor Pistillo, MD

CONTACT

54-011 4210-9000; npistillo@yahoo.com.ar

Mariano Rua, MD

CONTACT

54-011 4210-9000; nanofrua@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Intensive Care Unit at Hospital El Cruce

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 15, 2019
• Study Start: December 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share