AzTrials
AzTrials

SepsisNCT04117568

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

An observational study of Sepsis and Septic Shock, run by Göteborg University at 1 site in Sweden.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis, Septic Shock, Sepsis, Severe
What is being tested?
Blood sampling
How many people
10 participants
Where
1 siteSweden
Study dates
4 Sep 2019to 1 Apr 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Interrupted surgery
  • Neuropenia caused by cytostatics

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Sahlgrenska University Hospital

    Gothenburg, 41345

Other trials in Sweden

About this study

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.

Read the detailed description

Postoperative complications of any sort occurs in many of the patients undergoing high risk cancer surgery such as surgery for pancreatic, esophageal or ovarian malignancy (3, 4) These patients have a risk of wound infection mainly due to malnutrition and challenging surgical conditions (5, 6) A prolonged inflammatory response (overshoot) in some patients may lead to multiple organ failure (MOF) (7, 8).

Postoperative immunosuppression However, to handle the postoperative proinflammatory actions, patients also produce anti-inflammatory cytokines, mainly IL-4, IL-10 and IL-1 Ra. This is called compensatory inflammatory response syndrome (CARS). In cases of complications or malnutrition there may instead be an overshoot of the CARS mechanisms that lead to a suppression of the immune response (9, 10).

The surgical stress resulting in an imbalance in the inflammatory systems consume the circulating neutrophils and stresses the bone marrow to release immature, less efficient neutrophils, into the bloodstream, an event called emergency granulopoesis(11, 12).

Sepsis and ARDS Sepsis is one of the leading causes of death in Sweden and globally, and is characterized by an uncontrolled inflammatory reaction (13). The disease can affect everyone, including previously healthy people, and occurs when a normal bacterial infection invades the bloodstream and the body then responds with an inflammatory reaction. Acute organ dysfunction in sepsis primarily affects respiratory and circulatory systems (14). Pneumonia is the most common underlying cause of sepsis and respiratory insufficiency is the most common organ dysfunction in septic shock (15). Pneumonia with septic shock can develop into respiratory distress syndrome (ARDS) associated with a very high mortality rate, around 40% (16-18) Recently, ARDS was shown to be associated with migration of neutrophils, into the lung alveoli, and that such infiltration drives an inflammatory reaction, for which the pathophysiological mechanisms are incompletely mapped. Increased knowledge of the neutrophil role in ARDS could thus benefit the understanding of this complex syndrome(19, 20). In sepsis, the demand for enough circulating neutrophils to fight the infection is so high that reserve pools are exhausted and granulopoiesis switches to emergency mode. This results in release of immature neutrophils into circulation, the so-called left shift, used as an indicator of sepsis. As a result, circulating neutrophils in sepsis can be very heterogeneous, an effect also seen in autoimmune diseases and cancer (21). There are currently no tools to properly investigate these emergency neutrophil populations to utilize for diagnosis and disease follow-up.

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.

Settings, research designs, patients and methods This project is a collaboration between the Sahlgrenska University Hospital, and Gothenburg University, Gothenburg, Sweden.

Adult patients (>18 years of age) are found from the surgical waiting list at the Sahlgrenska University hospital as they are assessed and scheduled for surgery for different kinds of malignancies, pancreatic malignancy, esophageal malignancy and ovarian malignancy. Furthermore, in a second study we will include patients undergoing cardiac surgery, with a heart lung machine in operation during the surgery. These patients will also be included from the surgical waiting list.

Patients in septic shock will be included from daily rounds at the central intensive care unit at the Sahlgrenska university Hospital. Septic shock is defined by criteria from Surviving sepsis campaign or sepsis III. As only around 30% of patients that are diagnosed with septic shock has a positive blood culture we will include both patients with or without a positive blood culture. After obtaining informed consent, patients will leave venous blood samples 3-5 times during their admission. The rationale for this was that we are not entirely sure of when patients may or may not enter the stage of emergency granulopoesis, but based on results from previous studies, and to achieve reasonable feasibility of the study protocol with as little missing data as possible these three sampling occasions seemed a reasonable compromise.

Clinical significance The basic characterization of glycome and glycoproteome in neutrophil granules will give in¬sights into, and be correlated with, the glycoconjugate status in the cell precursor populations that may be prematurely released from the bone marrow upon emergency granulopoiesis in¬duced by disease, such as sepsis, severe aseptic inflammation (trauma), autoimmune disease and cancer. Hence, our studies of neutrophils from blood and bone marrow, as well as emergency neutrophils from patients with sepsis and corresponding model systems will enable us not only to build mechanistic models and glycan databases, but also to develop novel diagnostic tools to identify and monitor disease. Here, our primary focus is sepsis and the subsequent development of ARDS. In ARDS neutrophils migrate into the alveoli of the lungs and degranulate in order to kill off bacteria. However, in the process lung tissue is injured and the inflammatory process causing severe hypoxemia and life threatening respiratory failure is fueled-on. As the glycome and glycoproteome seems to play a role in discriminating between harmful bacteria and endogenous structures it is of importance to clarify if there is any possible interactions that could be made to control this part of the destructive inflammation.

Being tested
Blood sampling
Medical subject headings
Sepsis, Shock, Septic, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood samplingOther

    Also called No other intervention as this is an observational study

    Blood sampling at 3-5 occasions per admission

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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?

    Measured: 2019-2020

  2. 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?

    Measured: 2020

  3. 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?

    Measured: 2019-2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2019
  2. Study start4 Sep 2019
  3. Primary completion1 Apr 2020
  4. Study completion1 Apr 2020

Why it stopped: Due to Covid-19 pandemic.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04117568
Sponsor's protocol ID
AKB-Block
Status last verified
Aug 2021
First submitted
3 Oct 2019
Last updated
19 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis and Septic Shock, run by Göteborg University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Due to Covid-19 pandemic.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emergency granulopoesis in postoperative patients undergoing major surgery for malignancies. (time frame: 2019-2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in