An observational study in Sepsis, Septic Shock and Multi Organ Failure, sponsored by Ankara City Hospital Bilkent. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by Ankara City Hospital Bilkent · Observational
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:
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.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 250 is above the median of 108 across 406 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Ankara City Hospital Bilkent is the lead sponsor of 443 studies on the registry; 111 are open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients admitted to the intensive care unit of Ankara Bilkent City Hospital with a diagnosis of septic shock who met the inclusion criteria
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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 frame: Time from intensive care unit admission to mortality at the 28th day.
28-day intensive care mortality
The GDF-15 level will be used to predict intensive care unit mortality within 28 days of intensive care unit admission.
Time frame: 28 days after intensive care unit admission
Plan to share: No — In accordance with local legislation, the sharing of patient information is subject to special authorisation.
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