Can Gdf-15 Level Predict Progression to Multiple Organ Failure in Patients With Septic Shock
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sepsis, Septic Shock, Multi Organ Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Detailed description
Sepsis can be defined as a disproportionate host response to infection. It has been reported that 2.8 million deaths per year in high-income countries are associated with sepsis. Excessive inflammatory response may lead to organ failure and death after multiple organ failure. After infection, pathogen-mediated molecular fragments (PAMPS) are formed and recognised by toll-like receptors and the immune system is activated. Pro- and anti-inflammatory mediators are released and levels of various cytokines increase. These changes affect neutrophil-endothelial adhesion, disrupt the coagulation cascade and increase microthrombi formation. The systemic inflammatory state may be followed by immune paralysis and secondary infections, which may lead to the loss of patients as a result of multiple organ failure.
Growth differentiation factor-15 (GDF-15), also known as macrophage inhibitory cytokine-1 (MIC-1), is a member of the transforming growth factor-β (TGFβ) superfamily. It is found in many tissues and is strongly expressed in epithelial cells and macrophages. Its level is correlated with macrophage activation. In recent years, circulating GDF-15 level has been identified as a biomarker with prognostic value in cardiopulmonary diseases such as heart failure myocardial infarction and pulmonary embolism. In addition, elevated GDF-15 levels have been shown in end-stage renal failure and acute respiratory distress syndrome and chronic inflammatory diseases.
Septic shock requires vasopressor support to maintain a mean arterial pressure of 65 mmHg despite adequate fluid replacement. Septic shock has a higher mortality rate and development of multiple organ failure is more common.
Although the correlation of elevated GDF-15 levels with organ failure has been shown, the relationship between GDF-15 levels and multiple organ failure in patients with septic shock has not yet been studied.
Primary aim in this study is to investigate the relationship between GDF-15 level measured after admission and progression to multiple organ failure in patients admitted to intensive care with septic shock.
Secondary aim is to predict mortality with GDF-15 level in patients treated in intensive care unit with septic shock.
Primary outcome measures
- Predicting the progression to multiple organ failure in patients admitted to intensive care unit with septic shock by GDF-15 level [Time frame: Time from intensive care unit admission to mortality at the 28th day.]
Secondary outcome measures (1)
- 28-day intensive care mortality [Time frame: 28 days after intensive care unit admission]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Ankara Bilkent City Hospital — Ankara
Identifiers
NCT: NCT06808100 · TABED 2-24-659