NCT06704438

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

November 21, 2024

Last Update Submit

November 23, 2024

Conditions

Keywords

D-LactateSCUBE-1Critical Illness

Outcome Measures

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

    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.

Study Arms (2)

Control Group

The control group consisted of healthy individuals without any disease who voluntarily participated in the study.

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.

Diagnostic Test: D-Lactate

Interventions

D-LactateDIAGNOSTIC_TEST

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

Control GroupPatients Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni SUltan Suleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 37010317BACKGROUND
  • Tahirli T, Altuncı YA, Yalçınlı S. The Evaluation of In-Hospital Transportation of Emergency Room Critically Ill Patients. Genel Tıp Derg

    BACKGROUND
  • Robertson LC, Al-Haddad M. Recognizing the critically ill patient. Anaesthesia & Intensive Care Medicine

    BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASISTANT PROFESSOR

Study Record Dates

First Submitted

November 21, 2024

First Posted

November 26, 2024

Study Start

July 25, 2019

Primary Completion

January 1, 2020

Study Completion

January 15, 2020

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

It can be shared upon reaching the corresponding author.

Locations