National Early Warning Score and D-dimer to Identify Medical Patients at Low Risk of 30-day Mortality

Medical Patients in the Emergency Department Clinical Trial

Official title:

Combined Use of the National Early Warning Score and D-dimer to Identify Medical Patients at Low Risk of 30-day Mortality in a Danish Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03108807
• Other study ID #: S-20170005
• Status: Completed
• Phase: N/A
• First received: April 3, 2017
• Last updated: September 11, 2017
• Start date: April 24, 2017
• Est. completion date: August 19, 2017

Study information

• Verified date: September 2017
• Source: Hospital of South West Jutland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim is to determine if the National Early Warning Score combined with plasma D-dimer levels can be used in risk stratification of acutely ill medical patients presenting to a Danish Emergency Department. The investigators wish to identify patients at low risk of mortality within 30 days.

Description:

Large increases in emergency admissions are raising concerns about whether all admissions are necessary. If there was a fast and reliable system that could be used to determine the risk of all medical patients, many low-risk patients could be safely returned to primary care or outpatient follow-up clinics.

The investigators wish to determine, if the combination of the National Early Warning Score and plasma D-dimer levels can be used to identify patients at low risk of mortality within 30 days in an unselected group of medical patients presenting to a Danish Emergency Department.

This is a prospective observational study that will be performed on adult medical patients referred to the Emergency Department of a Danish hospital to be assessed for possible admission. The study will be performed in the Emergency Department of Hospital of South West Jutland in the region of Southern Denmark.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1700
• Est. completion date: August 19, 2017
• Est. primary completion date: August 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admission to the Emergency Department of Hospital of South West Jutland

• Requirement of any blood test

• Age 18 years

• Informed consent given

Exclusion Criteria:

• Age 18 years

• Informed consent not given

Related Conditions & MeSH terms

• Emergencies
• Medical Patients in the Emergency Department

Intervention

Diagnostic Test:
• D-dimer test
D-dimer test

Locations

Country	Name	City	State
Denmark	Hospital of South West Jutland	Esbjerg

Sponsors (2)

Lead Sponsor	Collaborator
Hospital of South West Jutland	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Nickel CH, Kellett J, Cooksley T, Bingisser R, Henriksen DP, Brabrand M. Combined use of the National Early Warning Score and D-dimer levels to predict 30-day and 365-day mortality in medical patients. Resuscitation. 2016 Sep;106:49-52. doi: 10.1016/j.resuscitation.2016.06.012. Epub 2016 Jun 20. — View Citation

Nickel CH, Kuster T, Keil C, Messmer AS, Geigy N, Bingisser R. Risk stratification using D-dimers in patients presenting to the emergency department with nonspecific complaints. Eur J Intern Med. 2016 Jun;31:20-4. doi: 10.1016/j.ejim.2016.03.006. Epub 2016 Apr 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-days mortality	mortality within 30 days after assessment will be determined for all patients using data extracted from the Danish Civil Registration System patients using data extracted from the Danish Civil Registration System	30 days
Secondary	Hospital length of stay (LOS)	length of stay will be calculated from the time of the patients' arrival at the hospital to the moment of the discharge for all patients using data extracted from the Danish National Patient Registry	30 days
Secondary	Readmissions within 30 days	readmissions within 30 days after primary assessment will be determined for all patients using data extracted from the Danish National Patient Registry	30 days