Presepsin:Gelsolin Ratio in Sepsis-related Organ Dysfunction

NCT05060679 | Completed

• 1 other identifier: 4327.316-2900/KK15/2011
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

In the present study, 126 patients were enrolled (23 control, 38 non-septic and 65 septic patients). Blood samples were collected from septic patients at the intensive care unit (ICU) at three time points (T1-3): T1: within 12h after admission; T2: second day morning; T3: third day morning. Sampling points for non-septic ICU patients were T1 and T3. Exclusion criteria were patients under 18 years of age, unobtainable consent, end-stage renal disease requiring chronic dialysis or kidney transplantation and patients with malignancies needing palliative care. Not more than one sample (venous blood) was collected from control patients. Plasma presepsin levels were determined by an automated chemiluminescence-based Point of Care instrument while serum gelsolin levels were measured using an automated immune turbidimetric assay. Plasma presepsin concentrations were expressed as pg/mL, while serum gelsolin levels were expressed as mg/L. Data were compared with laboratory and clinical parameters. Patients were categorized by the Sepsis-3 definitions and 10-day mortality data were investigated. Presepsin:gelsolin ratio was evaluated in major sepsis-related organ dysfunctions including hemodynamic disturbances, respiratory insufficiency and acute kidney injury (AKI).

Conditions

Sepsis; Acute Kidney Injury Due to Sepsis; Septic Shock; Acute Respiratory Distress Syndrome

Keywords

Sepsis-3; Organ dysfunction; Prognosis; Presepsin; Gelsolin; Presepsin:gelsolin ratio; Novel biomarker

Outcome Measures

Primary Outcomes (2)

• Plasma Presepsin concentrations

  Plasma samples were centrifuged (10 min, 1500 g), then sample aliquots were stored without preservatives at -70 °C until analysis. Plasma presepsin levels were measured using an automated Point of Care instrument (PATHFAST; LSI Medience Corporation, Tokyo, Japan) based on a chemiluminescent enzyme immunoassay.

  3 days

• Serum gelsolin concentrations

  Clotted blood samples were centrifuged (10 min, 1500 g), then sample aliquots were stored without preservatives at -70 °C until analysis. Serum gelsolin levels were determined with an automated immune turbidimetric assay (Cobas 8000/c502 module (Roche Diagnostics GmbH, Mannheim, Germany)).

  3 days

Secondary Outcomes (1)

• Presepsin:gelsolin ratios

  5 days

Study Arms (3)

Non-sepsis

Non-septic patients receive supportive treatment at the ICU.

Other: Supportive therapy at the ICU

Sepsis

Patients receive sepsis therapy.

Other: Sepsis therapy

Sepsis-related organ dysfunction

Patients receive sepsis therapy and advanced supportive treatment based on the occurrence of specific sepsis-related organ dysfunctions.

Other: Sepsis-related organ dysfunction therapy

Interventions

Supportive therapy at the ICU OTHER

Non-septic ICU patients received adequate supportive treatment (fluid resuscitation, respiratory, anticoagulation, antimicrobial and vasopressor therapy along with sedation, ulcer prophylaxis and nutrition. Blood sampling for non-septic patients were the first (T1) and third (T3) postoperative morning at the ICU. Besides, 23 healthy outpatients were documented without sepsis or sepsis-related organ dysfuntion as a control group.

Non-sepsis

Sepsis therapy OTHER

Patients receiving sepsis therapy followed the international guidelines of the 2016 Surviving Sepsis Campaign (SSC) regarding respiratory, antimicrobial, anticoagulation, vasopressor and hydrocortisone therapy, along with adequate fluid resuscitation, sedation, ulcer prophylaxis and nutrition. Blood samples were collected at the ICU from this patient group at three time points (T1-3): T1: within 12 hours after admission; T2: second day morning; T3: third day morning of follow-up.

Sepsis

Sepsis-related organ dysfunction therapy OTHER

Patient management of sepsis and sepsis-related organ dysfunction followed the international guidelines of the 2016 Surviving Sepsis Campaign (SSC) regarding respiratory, antimicrobial, anticoagulation, vasopressor and hydrocortisone therapy, along with adequate fluid resuscitation, sedation, ulcer prophylaxis, nutrition and renal replacement therapy (if needed). In this patient group, blood sampling was performed at three time points (T1-3): T1: within 12 hours after admission; T2: second day morning; T3: third day morning of follow-up.

Sepsis-related organ dysfunction

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy control individuals (n=23), non-septic ICU patients (n=38) and septic patients (n=65) were enrolled, while the septic group was also investigated based on the occurrence of sepsis-related organ dysfunction (e.g. acute kidney injury, hemodynamic instability, acute respiratory distress syndrome)

You may qualify if:

• Non-septic patients needing ICU supportive treatment after major surgical interventions
• Sepsis
• Sepsis-related organ dysfunction (e.g. acute kidney injury, hemodynamic instability, acute respiratory distress syndrome)

You may not qualify if:

• under 18 years of age
• unobtainable consent
• end-stage renal disease
• kidney transplantation
• malignancies needing palliative care

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Department of Anesthesiology and Intensive Therapy, Medical School, University of Pécs

Pécs, Baranya, 7624, Hungary

Location

Related Publications (1)

• Ragan D, Kustan P, Horvath-Szalai Z, Szirmay B, Miseta A, Woth G, Koszegi T, Muhl D. Presepsin: gelsolin ratio, as a promising marker of sepsis-related organ dysfunction: a prospective observational study. Front Med (Lausanne). 2023 May 5;10:1126982. doi: 10.3389/fmed.2023.1126982. eCollection 2023.

  PMID: 37215727 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood (Serum; Plasma)

MeSH Terms

Conditions

Sepsis; Shock, Septic; Respiratory Distress Syndrome; Meretoja syndrome

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Dániel Ragán, MD

  Department of Laboratory Medicine, Medical School, University of Pécs

  PRINCIPAL INVESTIGATOR

• Péter Kustán, MD, PhD

  Department of Laboratory Medicine, Medical School, University of Pécs

  PRINCIPAL INVESTIGATOR

• Zoltán Horváth-Szalai, MD, PhD

  Department of Laboratory Medicine, Medical School, University of Pécs

  PRINCIPAL INVESTIGATOR

• Balázs Szirmay, MD

  Department of Laboratory Medicine, Medical School, University of Pécs

  PRINCIPAL INVESTIGATOR

• Attila Miseta, MD, Dsc

  Department of Laboratory Medicine, Medical School, University of Pécs

  PRINCIPAL INVESTIGATOR

• Gábor Woth, MD, PhD

  Department of Anesthesiology and Intensive Therapy, Medical School, University of Pécs

  PRINCIPAL INVESTIGATOR

• Tamás Kőszegi, MD, PhD

  Department of Laboratory Medicine, Medical School, University of Pécs

  PRINCIPAL INVESTIGATOR

• Diána Mühl, MD, PhD

  Department of Anesthesiology and Intensive Therapy, Medical School, University of Pécs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: September 29, 2021
• Study Start: January 1, 2018
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)