NCT04117568

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

October 3, 2019

Last Update Submit

August 16, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Emergency granulopoesis in postoperative patients undergoing major surgery for malignancies.

    Outcome : Is there an emergency granulopoesis in this category of patients? When does the granulopoesis occur? To what extent are the neutrophils affected by the emergency granulopoesis? Can the neutrophils produce reactive oxygen species?

    2019-2020

  • Emergency granulopoesis perioperatively in patients undergoing cardiac surgery with the use of perioperative heart-lung machine.

    Is there an emergency granulopoesis in this category of patients? When does the granulopoesis occur? To what extent are the neutrophils affected by the emergency granulopoesis? Can the neutrophils produce reactive oxygen species?

    2020

  • Emergency granulopoesis in septic shock patients with and without a positive blood culture.

    Is there an emergency granulopoesis in this category of patients? When does the granulopoesis occur? To what extent are the neutrophils affected by the emergency granulopoesis? Can the neutrophils produce reactive oxygen species?

    2019-2020

Interventions

Blood sampling at 3-5 occasions per admission

Also known as: No other intervention as this is an observational study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postoperative patients or patients presenting with sepsis at Sahlgrenska University hospital, Gothenburg, Sweden

You may qualify if:

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

You may not qualify if:

  • Interrupted surgery
  • Neuropenia caused by cytostatics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

SepsisShock, SepticPostoperative Complications

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Anna Karlsson-Bengtsson, Prof

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 7, 2019

Study Start

September 4, 2019

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations