Critical IllnessNCT06704438
Diagnostic And Prognostic Value Of D-Lactate And Scube-1 Levels In Critically Ill Patients
An observational study of Critical Illness and D-Lactate, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to investigate the diagnostic and prognostic levels of D-Lactate and SCUBE-1 in critically ill patients being admitted to the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness, D-Lactate, SCUBE-1
- What is being tested?
- D-Lactate
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2019to 15 Jan 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who were diagnosed according to the criteria as being critically ill by the ED responsible physician (patients whose basic vital functions are unstable, who receive supportive treatment or whose general condition is expected to deteriorate) were included. Patients over 18 years of age who agreed to participate in the study were included after consent was obtained from the patient or their relatives. Patients who did not meet the definition of critical patients, whose follow-up was incomplete, who did not want to participate in the study, pregnant women, and patients under 18 years of age were all excluded. A healthy control group was formed from the relatives of the patients who came to the ED outpatient clinics, as well as hospital staff who wanted to participate in the study. Critical patients were divided into the following seven groups according to their emergency department diagnosis: central nervous system, cardiovascular system, respiratory system, gastrointestinal syst
Who may be able to join
- Age 18 years or older Evaluated as critically ill by emergency department physician
Who cannot join
- Patients not meeting critical illness criteria Patients with incomplete follow-up records Patients who declined to participate in the study Pregnant women Individuals under 18 years of age
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni SUltan Suleyman Training and Research Hospital
Istanbul, 34303
About this study
The investigators aimed to investigate the diagnostic and prognostic levels of D-Lactate and SCUBE-1 in critically ill patients being admitted to the emergency department.
Read the detailed description
Patients who were diagnosed according to the criteria as being critically ill by the ED responsible physician (patients whose basic vital functions are unstable, who receive supportive treatment or whose general condition is expected to deteriorate) were included. Patients over 18 years of age who agreed to participate in the study were included after consent was obtained from the patient or their relatives. Patients who did not meet the definition of critical patients, whose follow-up was incomplete, who did not want to participate in the study, pregnant women, and patients under 18 years of age were all excluded. A healthy control group was formed from the relatives of the patients who came to the ED outpatient clinics, as well as hospital staff who wanted to participate in the study.
Age, gender, known diseases, medications, vital parameters, and the laboratory results from critically ill patients and healthy volunteers admitted to the ED were recorded, and blood samples taken for D-Lactate and SCUBE-1 at the time of admission to the emergency room were placed in Ethylenediaminetetraacetic acid (EDTA) tubes. Clinical scores, such as the Glasgow Coma Scale (GCS), Acute Physiology and Chronic Health Evaluation (APACHE) II, Revised Trauma Score (RTS), and shock index were calculated. Critical patients were divided into the following seven groups according to their emergency department diagnosis: central nervous system, cardiovascular system, respiratory system, gastrointestinal system/metabolic, sepsis, trauma, and other. The clinical outcomes of these patients (ED length of stay, ICU or ward admission, ED and ICU mortality) were also noted. The relationship between the patient's clinical scoring (GCS, APACHE II, RTS and shock index ), laboratory results, and mortality status with D-Lactate and SCUBE-1 levels was compared. At the same time, the diagnostic value of d-lactate and SCUBE-1 for distinguishing critically ill patients was investigated.
- Conditions
- Critical Illness, D-Lactate, SCUBE-1
- Being tested
- D-Lactate
- Keywords
- D-Lactate, SCUBE-1, Critical Illness
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-LactateDiagnostic test
D-Lactate and SCUBE-1 can be used as early diagnosis and mortality indicators in critically ill patients.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | The control group consisted of healthy individuals without any disease who voluntarily participated in the study. Receives: Diagnostic Test: D-Lactate | |
| Patients Group | Patients over the age of 18 who were diagnosed as critically ill by the emergency department physician and who gave informed consent were included in the study. Receives: Diagnostic Test: D-Lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of D-Lactate and SCUBE-1 levels in patients who were diagnosed according to the criteria as being critically ill by the ED responsible physician and a control group
The investigators compared the plasma blood levels of biomarkers in both groups
Measured: The study was conducted with blood samples taken at the time of admission. The outcome measure will be assessed up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start25 Jul 2019
- Primary completion1 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramiz Yazıcı, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704438
- Sponsor's protocol ID
- 2019/17348
- Other IDs
- 2019
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It can be shared upon reaching the corresponding author.
Publications
Mitarai T, Gordon AJ, Nudelman MJR, Urdaneta AE, Nesbitt JL, Niknam K, Graber-Naidich A, Wilson JG, Kohn MA. Association of an Emergency Critical Care Program With Survival and Early Downgrade Among Critically Ill Medical Patients in the Emergency Department. Crit Care Med. 2023 Jun 1;51(6):731-741. doi: 10.1097/CCM.0000000000005835. Epub 2023 Apr 3.
PubMed 37010317Tahirli T, Altuncı YA, Yalçınlı S. The Evaluation of In-Hospital Transportation of Emergency Room Critically Ill Patients. Genel Tıp Derg
Robertson LC, Al-Haddad M. Recognizing the critically ill patient. Anaesthesia & Intensive Care Medicine
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic And Prognostic Value Of D-Lactate And Scube-1 Levels In Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06704438
- Acronym / sponsor ID
- 2019/17348
- Conditions
- Critical Illness, D-Lactate, SCUBE-1
- Keywords
- D-Lactate, SCUBE-1, Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 26 Nov 2024 (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 investigators aimed to investigate the diagnostic and prognostic levels of D-Lactate and SCUBE-1 in critically ill patients being admitted to the emergency department.
Detailed description
Patients who were diagnosed according to the criteria as being critically ill by the ED responsible physician (patients whose basic vital functions are unstable, who receive supportive treatment or whose general condition is expected to deteriorate) were included. Patients over 18 years of age who agreed to participate in the study were included after consent was obtained from the patient or their relatives. Patients who did not meet the definition of critical patients, whose follow-up was incomplete, who did not want to participate in the study, pregnant women, and patients under 18 years of age were all excluded. A healthy control group was formed from the relatives of the patients who came to the ED outpatient clinics, as well as hospital staff who wanted to participate in the study.
Age, gender, known diseases, medications, vital parameters, and the laboratory results from critically ill patients and healthy volunteers admitted to the ED were recorded, and blood samples taken for D-Lactate and SCUBE-1 at the time of admission to the emergency room were placed in Ethylenediaminetetraacetic acid (EDTA) tubes. Clinical scores, such as the Glasgow Coma Scale (GCS), Acute Physiology and Chronic Health Evaluation (APACHE) II, Revised Trauma Score (RTS), and shock index were calculated. Critical patients were divided into the following seven groups according to their emergency department diagnosis: central nervous system, cardiovascular system, respiratory system, gastrointestinal system/metabolic, sepsis, trauma, and other. The clinical outcomes of these patients (ED length of stay, ICU or ward admission, ED and ICU mortality) were also noted. The relationship between the patient's clinical scoring (GCS, APACHE II, RTS and shock index ), laboratory results, and mortality status with D-Lactate and SCUBE-1 levels was compared. At the same time, the diagnostic value of d-lactate and SCUBE-1 for distinguishing critically ill patients was investigated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Diagnostic Test: D-LactateThe control group consisted of healthy individuals without any disease who voluntarily participated in the study. |
| Patients Group | – | Diagnostic Test: D-LactatePatients over the age of 18 who were diagnosed as critically ill by the emergency department physician and who gave informed consent were included in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed according to the criteria as being critically ill by the ED responsible physician (patients whose basic vital functions are unstable, who receive supportive treatment or whose general condition is expected to deteriorate) were included. Patients over 18 years of age who agreed to participate in the study were included after consent was obtained from the patient or their relatives. Patients who did not meet the definition of critical patients, whose follow-up was incomplete, who did not want to participate in the study, pregnant women, and patients under 18 years of age were all excluded. A healthy control group was formed from the relatives of the patients who came to the ED outpatient clinics, as well as hospital staff who wanted to participate in the study. Critical patients were divided into the following seven groups according to their emergency department diagnosis: central nervous system, cardiovascular system, respiratory system, gastrointestinal syst
Key inclusion criteria (1 listed)
- Age 18 years or older Evaluated as critically ill by emergency department physician
Key exclusion criteria (1 listed)
- Patients not meeting critical illness criteria Patients with incomplete follow-up records Patients who declined to participate in the study Pregnant women Individuals under 18 years of age
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 |
|---|---|---|
| D-LactateD-Lactate and SCUBE-1 can be used as early diagnosis and mortality indicators in critically ill patients. | Diagnostic test | Control Group, Patients Group |
Primary outcome
Comparison of D-Lactate and SCUBE-1 levels in patients who were diagnosed according to the criteria as being critically ill by the ED responsible physician and a control group
Time frame: The study was conducted with blood samples taken at the time of admission. The outcome measure will be assessed up to 24 weeks.
The investigators compared the plasma blood levels of biomarkers in both groups
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 26 Nov 2024.
- Results publication: PubMed 37010317Mitarai T, Gordon AJ, Nudelman MJR, Urdaneta AE, Nesbitt JL, Niknam K, Graber-Naidich A, Wilson JG, Kohn MA. Association of an Emergency Critical Care Program With Survival and Early Downgrade Among Critically Ill Medical Patients in the Emergency Department. Crit Care Med. 2023 Jun 1;51(6):731-741. doi: 10.1097/CCM.0000000000005835. Epub 2023 Apr 3.
- Results publicationTahirli T, Altuncı YA, Yalçınlı S. The Evaluation of In-Hospital Transportation of Emergency Room Critically Ill Patients. Genel Tıp Derg
- Results publicationRobertson LC, Al-Haddad M. Recognizing the critically ill patient. Anaesthesia & Intensive Care Medicine
- Individual participant dataSharing planned: No. It can be shared upon reaching the corresponding author.
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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.
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 Critical Illness and D-Lactate, run by Kanuni Sultan Suleyman Training and Research Hospital 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 1 inclusion and 1 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 26 Nov 2024. 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?
Comparison of D-Lactate and SCUBE-1 levels in patients who were diagnosed according to the criteria as being critically ill by the ED responsible physician and a control group (time frame: The study was conducted with blood samples taken at the time of admission. The outcome measure will be assessed up to 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06704438, which also lists 3 linked publications.
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 26 Nov 2024.