NCT03143062

Brief Summary

To this date no clinical evaluation reports of the dynamics in the National Early Warning Score (NEWS) for those patients who suffer an in-hospital cardiac arrest, IHCA, exists. This process needs to be investigated in order to optimize the future care of these patients. Research Questions H1: Patients that suffer an IHCA has had higher NEWS in the preceding 24 hours from the event compared to those who did not suffer an IHCA. H2: The dynamics in the NEWS, differs between the patients that suffer an IHCA and those who do not in the preceding 24 hours from the event.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
381

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

September 30, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2018

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

April 24, 2017

Last Update Submit

September 3, 2018

Conditions

Keywords

National Early Warning ScoreRapid response system

Outcome Measures

Primary Outcomes (1)

  • Dynamics in the National Early Warning Score (NEWS) in the 24 hours preceding an in-hospital cardiac arrest.

    All documented National Early Warning Scores (NEWS) on eligible patients admitted to a hospital ward will be collected. The NEWS will be divided into different timespans in the 24 hours preceding the in-hospital cardiac arrest. A control group of patients will also have their NEWS collected. The NEWS of the control group and the cases will then be entered into the hypothesis testing. The aim is to find some dynamics in the NEWS that separates the patients that suffers an in-hospital cardiac arrest from those who do not in the 24 hours preceding the event.

    24 hours preceding an in-hospital cardiac arrest

Study Arms (2)

Cases

150 patients that suffered an in-hospital cardiac arrest in a hospital ward.

Diagnostic Test: NEWS

Controls

300 patients that did not suffer an in-hospital cardiac arrest but was treated in a hospital ward.

Diagnostic Test: NEWS

Interventions

NEWSDIAGNOSTIC_TEST

NEWS

CasesControls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in hospital wards

You may qualify if:

  • All patients ≥18 years of age admitted to the hospitals during a period of 12 months will be reviewed for eligibility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Skåne

Kristianstad, Sweden

Location

Study Officials

  • Karin Samuelson, Ass Professor

    Region Skåne

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 24, 2017

First Posted

May 8, 2017

Study Start

September 30, 2017

Primary Completion

September 2, 2018

Study Completion

September 2, 2018

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations