SepsisNCT05310812
Evaluation of Candidate Biomarkers to Predict Disease Severity and Acute Kidney Injury in Sepsis Patients
An observational study of Sepsis and Septic Shock, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Investigators predict that the information that can be obtained in terms of renal functions before clinical development in sepsis patients can be valuable in terms of guiding treatment algorithms, planning renal replacement therapies and using drugs that are toxic to the kidneys. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Acute Kidney Injury
- What is being tested?
- Biochemical evaluation.
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 29 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 diagnosed with sepsis and septic shock according to the "The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)" guideline.
Who may be able to join
- Patients diagnosed with sepsis and septic shock according to the "The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)" guideline.
- Signing of the Informed Consent Form by the patient or his legal representative.
Who cannot join
- Patients under 18 years of age.
- They are pregnant.
- Malignant patients in the terminal period with no expected survival.
- The Informed Consent Form is not signed by the patient or patient's relative.
- Sepsis and septic shock patients admitted from another hospital under vasopressor or on mechanical ventilator.
- Patients who develop brain damage and multi-organ failure after cardiopulmonary resuscitation.
- Chronic renal failure patients receiving dialysis treatment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculy of Medicine
Istanbul, 34093
About this study
Official title: Evaluation of Candidate Biomarkers to Predict Disease Severity and Acute Kidney Injury in Sepsis Patients in the Intensive Care Unit: Prospective Observational Study
Investigators predict that the information that can be obtained in terms of renal functions before clinical development in sepsis patients can be valuable in terms of guiding treatment algorithms, planning renal replacement therapies and using drugs that are toxic to the kidneys.
Read the detailed description
Despite the developments in Intensive Care Units (ICU), mortality and morbidity rates due to sepsis and septic shock are still high and it is seen as one of the major causes of death in ICU patients. Acute kidney injury (AKI) is a common disease worldwide and is seen in approximately 60% of intensive care hospitalizations. Diagnosis is generally made by the increase in serum creatinine level. Although it is a basic marker for AKI in current conditions, its levels can be misleading in clinical practice, especially in sepsis patients characterized by clinical conditions such as multiple organ failure. For these reasons, there is a need for new and applicable biomarkers that can be used in planning organ support treatments that can be applied to renal function in sepsis patients.
The utility of a new marker called presepsin in disease course, prognosis determination and sepsis-associated AKI clinic has been demonstrated. There are studies showing that neutrophil gelatinase-associated lipocalin (NGAL) is more valuable when compared to creatinine in patients with sepsis-associated AKI. Proenkephalin is a new biomarker studied, and it has been studied with NGAL in patients with cardiogenic shock, and it has been shown to have a place in the prediction of AKI in patients with cardiogenic shock. Significant elevation of syndecan-1 in acute kidney injury has been demonstrated in animal studies and clinical studies. In the literature, as far as investigators know, proenkephalin and syndecan-1 have not been studied in terms of AKI in sepsis patients.
In our study, investigators plan to investigate the role of biomarkers such as presepsin, syndecan-1, NGAL, and proenkephalin in predicting the risk of developing AKI in sepsis patients. The relevant markers will be studied from the blood sample taken from the patients diagnosed with sepsis at the time of diagnosis, and the results will be analyzed in terms of markers that may be more useful in predicting the development of AKI in patients. In addition, investigators aim to obtain clinical information by investigating whether these biomarkers have predictive properties on disease prognosis and mortality.
- Conditions
- Sepsis, Septic Shock, Acute Kidney Injury
- Being tested
- Biochemical evaluation.
- Keywords
- Sepsis, Acute Kidney Injury, Presepsin, Proenkefalin, Sindekan-1
- Medical subject headings
- Sepsis, Shock, Septic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biochemical evaluation.Diagnostic test
Also called Presepsin, NGAL, Syndecan-1, Proencephalin
Blood will be taken for biochemical evaluation-ELISA.
| Study group | Role | What they receive |
|---|---|---|
| Control group (Sepsis - no acute kindey injury) | Septic patients diagnosed by sepsis criteria but no have an acute kidney injury. (According ot KDIGO classification - creatinin values).
Blood plasma will be taken for biochemical evaluation. Receives: Diagnostic Test: Biochemical evaluation. | |
| Study group (Sepsis induced acute kidney injury) | Septic patients diagnosed by sepsis criteria, and have an acute kidney injury. (According ot KDIGO classification - creatinin values).
Blood plasma will be taken for biochemical evaluation. Receives: Diagnostic Test: Biochemical evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
KDIGO classification for acute kidney injury and biomarkers (ELISA test for Presepsin, Proencephalin, Syndecan-1 NGAL)
Measured: 1st day in ICU
Mortality
Relationship between mortality rates and biomarkers (CRP, procalcitonin, white blood cell count, ELISA test for Presepsin, Proencephalin, Syndecan-1, NGAL.
Measured: 1st day in ICU
Secondary outcomes (1)
Disesase severity
Relationship between APACHE-SOFA scores and biomarkers (ELISA test for Presepsin, Proencephalin, Syndecan-1, NGAL)
Measured: 1st day in ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Dec 2021
- Primary completion30 Jun 2022
- Study completion29 Nov 2022
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.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mert CANBAZ, Istanbul University
- Investigators
- Figen ESEN, Prof. Dr., Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310812
- Sponsor's protocol ID
- 2021/1907
- Status last verified
- Nov 2023
- First submitted
- 27 Feb 2022
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Candidate Biomarkers to Predict Disease Severity and Acute Kidney Injury in Sepsis Patients in the Intensive Care Unit: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05310812
- Acronym / sponsor ID
- 2021/1907
- Conditions
- Sepsis, Septic Shock, Acute Kidney Injury
- Keywords
- Sepsis, Acute Kidney Injury, Presepsin, Proenkefalin, Sindekan-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 5 Apr 2022 (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.
Investigators predict that the information that can be obtained in terms of renal functions before clinical development in sepsis patients can be valuable in terms of guiding treatment algorithms, planning renal replacement therapies and using drugs that are toxic to the kidneys.
Detailed description
Despite the developments in Intensive Care Units (ICU), mortality and morbidity rates due to sepsis and septic shock are still high and it is seen as one of the major causes of death in ICU patients. Acute kidney injury (AKI) is a common disease worldwide and is seen in approximately 60% of intensive care hospitalizations. Diagnosis is generally made by the increase in serum creatinine level. Although it is a basic marker for AKI in current conditions, its levels can be misleading in clinical practice, especially in sepsis patients characterized by clinical conditions such as multiple organ failure. For these reasons, there is a need for new and applicable biomarkers that can be used in planning organ support treatments that can be applied to renal function in sepsis patients.
The utility of a new marker called presepsin in disease course, prognosis determination and sepsis-associated AKI clinic has been demonstrated. There are studies showing that neutrophil gelatinase-associated lipocalin (NGAL) is more valuable when compared to creatinine in patients with sepsis-associated AKI. Proenkephalin is a new biomarker studied, and it has been studied with NGAL in patients with cardiogenic shock, and it has been shown to have a place in the prediction of AKI in patients with cardiogenic shock. Significant elevation of syndecan-1 in acute kidney injury has been demonstrated in animal studies and clinical studies. In the literature, as far as investigators know, proenkephalin and syndecan-1 have not been studied in terms of AKI in sepsis patients.
In our study, investigators plan to investigate the role of biomarkers such as presepsin, syndecan-1, NGAL, and proenkephalin in predicting the risk of developing AKI in sepsis patients. The relevant markers will be studied from the blood sample taken from the patients diagnosed with sepsis at the time of diagnosis, and the results will be analyzed in terms of markers that may be more useful in predicting the development of AKI in patients. In addition, investigators aim to obtain clinical information by investigating whether these biomarkers have predictive properties on disease prognosis and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (Sepsis - no acute kindey injury) | – | Diagnostic Test: Biochemical evaluation.Septic patients diagnosed by sepsis criteria but no have an acute kidney injury. (According ot KDIGO classification - creatinin values). Blood plasma will be taken for biochemical evaluation. |
| Study group (Sepsis induced acute kidney injury) | – | Diagnostic Test: Biochemical evaluation.Septic patients diagnosed by sepsis criteria, and have an acute kidney injury. (According ot KDIGO classification - creatinin values). Blood plasma will be taken for biochemical evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with sepsis and septic shock according to the "The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)" guideline.
Key inclusion criteria (2 listed)
- Patients diagnosed with sepsis and septic shock according to the "The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)" guideline.
- Signing of the Informed Consent Form by the patient or his legal representative.
Key exclusion criteria (7 listed)
- Patients under 18 years of age.
- They are pregnant.
- Malignant patients in the terminal period with no expected survival.
- The Informed Consent Form is not signed by the patient or patient's relative.
- Sepsis and septic shock patients admitted from another hospital under vasopressor or on mechanical ventilator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biochemical evaluation.Also: Presepsin, NGAL, Syndecan-1, ProencephalinBlood will be taken for biochemical evaluation-ELISA. | Diagnostic test | Control group (Sepsis - no acute kindey injury), Study group (Sepsis induced acute kidney injury) |
Primary outcome
Acute kidney injury
Time frame: 1st day in ICU
KDIGO classification for acute kidney injury and biomarkers (ELISA test for Presepsin, Proencephalin, Syndecan-1 NGAL)
Mortality
Time frame: 1st day in ICU
Relationship between mortality rates and biomarkers (CRP, procalcitonin, white blood cell count, ELISA test for Presepsin, Proencephalin, Syndecan-1, NGAL.
1 secondary outcome
Disesase severity
Time frame: 1st day in ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
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Integrated Medicine for Sepsis: An RCT With Phenotyping
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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. This study is not recruiting at the moment.
Figen ESEN, Prof. Dr. study director
Istanbul University
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 Istanbul University 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 30 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute kidney injury (time frame: 1st day in ICU). The study lists 2 primary outcomes in all. 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 30 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.