Diagnostic and Prognostic Value of D-Lactate and Scube-1 Levels in Critically Ill Patients

Completed

• Conditions: Critical Illness; D-Lactate; SCUBE-1

• Registration Number: NCT06704438
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief 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.

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 Timeline

• Study Start: 2019-07-25
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-15
• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-23
• Last Update Submitted: 2024-11-23
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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

Trial Locations

Locations (1)

Kanuni SUltan Suleyman Training and Research Hospital; 🇹🇷 İstanbul, Turkey