Presepsin:Gelsolin Ratio in Sepsis-related Organ Dysfunction

NCT05060679 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 126

Last updated 2022-04-04

No results posted yet for this study

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

Interventions

OTHER

Supportive therapy at the ICU

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.

OTHER

Sepsis therapy

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.

OTHER

Sepsis-related organ dysfunction therapy

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.

Sponsors & Collaborators

  • University of Pecs

    lead OTHER

Principal Investigators

  • Dániel Ragán, MD · Department of Laboratory Medicine, Medical School, University of Pécs

  • Péter Kustán, MD, PhD · Department of Laboratory Medicine, Medical School, University of Pécs

  • Zoltán Horváth-Szalai, MD, PhD · Department of Laboratory Medicine, Medical School, University of Pécs

  • Balázs Szirmay, MD · Department of Laboratory Medicine, Medical School, University of Pécs

  • Attila Miseta, MD, Dsc · Department of Laboratory Medicine, Medical School, University of Pécs

  • Gábor Woth, MD, PhD · Department of Anesthesiology and Intensive Therapy, Medical School, University of Pécs

  • Tamás Kőszegi, MD, PhD · Department of Laboratory Medicine, Medical School, University of Pécs

  • Diána Mühl, MD, PhD · Department of Anesthesiology and Intensive Therapy, Medical School, University of Pécs

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • Hungary

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05060679 on ClinicalTrials.gov