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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; D-Lactate; SCUBE-1
• Intervention / Treatment: Diagnostic test: D-Lactate

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 Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34303
    • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group; The control group consisted of healthy individuals without any disease who voluntarily participated in the study.	Diagnostic test: D-Lactate; D-Lactate and SCUBE-1 can be used as early diagnosis and mortality indicators in critically ill patients.
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.	Diagnostic test: D-Lactate; D-Lactate and SCUBE-1 can be used as early diagnosis and mortality indicators in critically ill patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The study was conducted with blood samples taken at the time of admission. The outcome measure will be assessed up to 24 weeks.

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Publications and helpful links

General 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.
• Tahirli 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 record dates

Study Major Dates

• Study Start (Actual): July 25, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 23, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 23, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Critical Illness; SCUBE-1; D-Lactate
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2019/17348

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It can be shared upon reaching the corresponding author.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No