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The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients

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ClinicalTrials.gov Identifier: NCT04117568
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Göteborg University

Brief Summary:
Background Surgery and inflammation Surgical trauma elicits an immune response aiming to initiate healing and remove debris and damaged tissue locally at the wound site (1). This local reaction includes a considerable production of cytokines and chemokines that enters the circulation and initiate a systemic inflammatory response mediated by circulating cytokines and chemokines. This response is called systemic inflammatory immune response (SIRS) and is an aseptic systemic inflammation. Postoperative inflammation produces proinflammatory cytokines, mainly IL-6, IL1 beta, and tumor necrosis factor alfa (2). Neutrophils and emergency granulopoesis Polymorphonuclear neutrophils constitute the most abundant population of white blood cells. Their main task is to provide innate immune protection of the host from microbial attack, migrating to the site of infection, engulfing the microbes by phagocytosis, and killing the prey through attack by reactive oxygen species (ROS) and antimicrobial granule pro¬teins (22). Upon systemic infection or inflammation, e.g., sepsis or trauma, the bone marrow enters a state of emergency granulopoiesis, drenched in cytokines that augment production and survival of neutrophils for rapid delivery to the blood (23-25). Recently, advanced techniques have evolved that al¬low the isolation of different developmental stages of steady-state and emergency neutrophils, and characterization of these has just begun (26). Glycans Glycans (polysaccharides) attached to proteins and lipids on the surfaces on immune cells serve as ligands for glycan-binding proteins, lectins. Several neutrophil processes are directed by gly¬can - lectin interactions; selectin-directed rolling on the endothelium, siglec-mediated in¬hibitory signals, and activation of effector function by galectins. Many of the proteins that end up in neutrophil intra-cellular granules are highly glycosylated, but not much is known about if and how the neutrophil glycome evolves during the 'targeting-by-timing' process of differentiation and how this is affected by emergency granulopoiesis during systemic infection and inflammation. Here is a clear knowledge gap.

Condition or disease Intervention/treatment
Sepsis Septic Shock Sepsis, Severe Post-Op Complication SIRS Other: Blood sampling

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Actual Study Start Date : September 4, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Intervention Details:
  • Other: Blood sampling
    Blood sampling at 3-5 occasions per admission
    Other Name: No other intervention as this is an observational study


Primary Outcome Measures :
  1. Emergency granulopoesis in postoperative patients undergoing major surgery for malignancies (10-20 pts) [ Time Frame: 2019-2020 ]
    The aim of this study is to find out if there is an emergency granulopoesis in patients undergoing major surgery and sepsis, and furthermore if there is any structural or functional deviations in neutrophils from patients undergoing major surgery or sepsis that is associated with the attenuated immune response after surgery. Our hypothesis is that patients undergoing major surgery or sepsis do enter an emergency granulopoesis and that this results in the release of structurally and functionally deviating neutrophils.

  2. Emergency granulopoesis perioperatively in patients undergoing cardiac surgery with the use of perioperative heart-lung machine (10-20 pts) [ Time Frame: 2020 ]
    The aim of this study is to find out if there is an emergency granulopoesis in patients undergoing major surgery and sepsis, and furthermore if there is any structural or functional deviations in neutrophils from patients undergoing major surgery or sepsis that is associated with the attenuated immune response after surgery. Our hypothesis is that patients undergoing major surgery or sepsis do enter an emergency granulopoesis and that this results in the release of structurally and functionally deviating neutrophils.

  3. Emergency granulopoesis in septic shock patients with and without a positive blood culture (30-40 pts) [ Time Frame: 2019-2020 ]
    The aim of this study is to find out if there is an emergency granulopoesis in patients undergoing major surgery and sepsis, and furthermore if there is any structural or functional deviations in neutrophils from patients undergoing major surgery or sepsis that is associated with the attenuated immune response after surgery. Our hypothesis is that patients undergoing major surgery or sepsis do enter an emergency granulopoesis and that this results in the release of structurally and functionally deviating neutrophils.


Biospecimen Retention:   Samples With DNA
Blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Postoperative patients or patients presenting with sepsis at Sahlgrenska University hospital, Gothenburg, Sweden
Criteria

Inclusion Criteria: Patients over 18 years of age undergoing surgery or presenting with sepsis according to definitions.

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Exclusion Criteria:

  • Interrupted surgery Neuropenia caused by cytostatics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117568


Contacts
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Contact: Linda Block, MD, PhD +46709955110 linda.block@gu.se
Contact: Richard Vithal, MD richard.vithal@gu.se

Locations
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Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Göteborg University
Investigators
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Principal Investigator: Anna Karlsson-Bengtsson, Prof Göteborg University

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT04117568     History of Changes
Other Study ID Numbers: AKB-Block
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Toxemia
Emergencies
Postoperative Complications
Disease Attributes
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation