SepsisNCT06808100
Can Gdf-15 Level Predict Progression to Multiple Organ Failure in Patients With Septic Shock
An observational study of Sepsis and Septic Shock, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Multi Organ Failure
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 30 Apr 2026
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 9Show fewer
- Non-pregnant patients
- Patients without chronic immunodeficiency
- Patients without chronic inflammatory disease
Who cannot join
- 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
Show all 9Show fewer
- Pregnant patients
- Patients with chronic immunodeficiency
- Patients with chronic inflammatory diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
Read the 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.
- 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
- Medical subject headings
- Sepsis, Shock, Septic, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time from intensive care unit admission to mortality at the 28th day.
Secondary outcomes (1)
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.
Measured: 28 days after intensive care unit admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 May 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cihangir Doğu, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808100
- Sponsor's protocol ID
- TABED 2-24-659
- Status last verified
- May 2025
- First submitted
- 29 Jan 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In accordance with local legislation, the sharing of patient information is subject to special authorisation.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Gdf-15 Level Predict Progression to Multiple Organ Failure in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT06808100
- Acronym / sponsor ID
- TABED 2-24-659
- 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
28-day intensive care mortality
Time frame: 28 days after intensive care unit admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No. In accordance with local legislation, the sharing of patient information is subject to special authorisation.
Related trials for Sepsis
Active, not recruitingObservational study
Biomarker-enhanced Artificial Intelligence Based Pediatric Sepsis Screening Tool
Sepsis
Not yet recruiting
Blood Purification in Septic Children
Sepsis, Blood Purification
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
RecruitingObservational study
Metabolic and Functional Study of γδ T Cells in Critically Ill Patients
Sepsis, Critical Illness
Not yet recruiting
Safflower (Carthamus Tinctorius L.) Granules for Sepsis-associated Coagulopathy
Sepsis, Disseminated Intravascular Coagulation (DIC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025; AzTrials last refreshed its copy on 28 Oct 2026.