NCT04670458

Brief Summary

Current studies have shown that hospitalized ICU patients have a high risk of IHCA, with an incidence of about 0.6-7.8%. Early prediction of the occurrence of IHCA in severe patients can provide early intervention, prevent the deterioration of the disease, and reduce the incidence of IHCA. Therefore, researchers wanted to verify the efficacy of MEWS, NEWS, and CART scores in predicting IHCA in ICU inpatients, and to establish an early-warning scoring model that could effectively predict the risk of IHCA occurrence in ICU inpatients during hospitalization.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

12 months

First QC Date

November 26, 2020

Last Update Submit

December 10, 2020

Conditions

In-Hospital Cardiac Arrest

Keywords

Critically ill patientsIn-Hospital Cardiac ArrestEarly recognitionEarly warning score

Outcome Measures

Primary Outcomes (1)

  • In-Hospital Cardiac Arrest

    Cardiac arrest occurs during hospitalization

    Day 2

Study Arms (2)

CA group

Patients with In-Hospital Cardiac Arrest

Other: no intervention

CONTROL group

Patients without In-Hospital Cardiac Arrest

Other: no intervention

Interventions

no interventionOTHER

no intervention

CA groupCONTROL group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in the intensive care unit (ICU, CCU, RICU, EICU, NCU and DICU) of Qilu Hospital of Shandong University from January 1, 2017 to October 31, 2019 were selected.

You may qualify if:

  • Occurrence of IHCA
  • Hospital stay ≥48h.

You may not qualify if:

  • \<14 years
  • Do Not Resuscitat
  • Patients hospitalized due to out-of-hospital cardiac arrest
  • Cardiac arrest occurs during the operation
  • The patients with implanted cardiac pacemaker suffered cardiac arrest due to instrument malfunction.
  • CONTROL group
  • Without IHCA
  • Hospital stay ≥48h
  • \<14 years
  • Leave hospital without medical advice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Central Study Contacts

Wentao Sang

CONTACT

15153187102752318151@qq.com

Feng Xu

CONTACT

18560083066xufengsdu@126.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2020

First Posted

December 17, 2020

Study Start

October 1, 2020

Primary Completion

September 30, 2021

Study Completion

December 31, 2021

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations

CN(1)