Can Gdf-15 Level Predict Progression to Multiple Organ Failure in Patients With Septic Shock

NCT06808100 | Enrolling By Invitation

• 1 other identifier: TABED 2-24-659
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study is to investigate whether GDF-15 levels can predict clinical outcome in patients admitted to the intensive care unit with a diagnosis of septic shock. The main question is:

• Can the level of GDF-15 levels during ICU admission predict the development of multiple organ failure in patients with septic shock? All patients will continue to receive routine treatment for sepsis and septic shock. The investigators will observe the development of multiple organ failure by the Sequential Organ Failure Assessment (SOFA) score increase

Conditions

Sepsis; Septic Shock; Multi Organ Failure

Keywords

Growth and differentiation factor 15; sepsis; septic shock; Multiple Organ Dysfunction Syndrome; Sequential Organ Failure Assessment score

Outcome Measures

Primary Outcomes (1)

• Predicting the progression to multiple organ failure in patients admitted to intensive care unit with septic shock by GDF-15 level

  Sequential Organ Failure Assessment (SOFA) score is a computational score used to assess the status of organ systems. The SOFA is based on six different scores scored from 0 to 4 for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems, with an increasing score reflecting worsening organ dysfunction. In the research, sepsis treatment and appropriate haemodynamic support treatment will be provided to patients and daily sofa score follow-up will be performed. Progression to multiple organ failure will be monitored with the sofa score.

  Time from intensive care unit admission to mortality at the 28th day.

Secondary Outcomes (1)

• 28-day intensive care mortality

  28 days after intensive care unit admission

Study Arms (1)

group I

Patients older than 18 years of age who agreed to participate in the study. Patients fulfilling the inclusion criteria. Patients diagnosed with sepsis and in need of vasopressors. Patients treated in the intensive care unit for more than 48 hours. Patients whose blood sample could be collected for GDF-15 after transfer to the intensive care unit.

Eligibility Criteria

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

Study Population

Patients admitted to the intensive care unit of Ankara Bilkent City Hospital with a diagnosis of septic shock who met the inclusion criteria

You may qualify if:

• Patients older thab 18 years of age
• Patients with septic shock
• Patients without end-stage renal failure (KDIGO G4,G5)
• Patients without chronic liver disease
• Patients with New York Heart Association (NYHA) stage 1-2
• Patients not diagnosed with active cancer
• Non-pregnant patients
• Patients without chronic immunodeficiency
• Patients without chronic inflammatory disease

You may not qualify if:

• Patients younger than 18 years age
• Patients not diagnosed with septic shock
• Patients with end-stage renal failure
• Patients with chronic liver disease
• Patients with New York Heart Association (NYHA) stage 3-4
• Patients diagnosed with active cancer
• Pregnant patients
• Patients with chronic immunodeficiency
• Patients with chronic inflammatory diseases

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample for GDF-15 level at the day of admission

MeSH Terms

Conditions

Sepsis; Shock, Septic; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 5, 2025
• Study Start: May 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)