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Completed

NCT Number: NCT06704438

Diagnostic And Prognostic Value Of D-Lactate And Scube-1 Levels In Critically Ill Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kanuni SUltan Suleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18 years or older Evaluated as critically ill by emergency department physician

Exclusion criteria

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

Treatment and study plan

D-Lactate

Diagnostic Test

D-Lactate and SCUBE-1 can be used as early diagnosis and mortality indicators in critically ill patients.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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