NCT03626961

Brief Summary

To determine the ability of the NEWS at tertiary intensive care unit discharges to predict the development of clinical deterioration. To determine a cut-off value for NEWS score for early readmission

Trial Health

87
On Track

Trial Health Score

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

Enrollment
538

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

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

December 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

1.1 years

First QC Date

August 8, 2018

Last Update Submit

August 5, 2019

Conditions

Keywords

NEWS

Outcome Measures

Primary Outcomes (1)

  • Readmission rate

    Clinical deterioration within 48 hours after ICU transfer

    48 hours

Study Arms (2)

discharge

patients discharged from icu

Other: readmissionOther: discharge

readmission

patients readmitted icu in 48 hours after icu discharge

Other: readmissionOther: discharge

Interventions

Readmission after 48 hours

dischargereadmission

Discharge

dischargereadmission

Eligibility Criteria

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

Surgical and medical patients who met the criteria of the tertiary stage intensive care unit

You may qualify if:

  • Older than 18 years old
  • Stay higher than 48 hours

You may not qualify if:

  • Under 18 years old
  • Stay lower than 48 hours
  • Intoxication
  • Exitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hitit university

Çorum, Çorum, 19100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Patient ReadmissionDrainage

Intervention Hierarchy (Ancestors)

HospitalizationPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesSurgical Procedures, Operative

Study Officials

  • Ozgur Yagan, Assoc.Prof.

    Hitit universtiy

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

August 8, 2018

First Posted

August 13, 2018

Study Start

December 1, 2017

Primary Completion

January 1, 2019

Study Completion

June 30, 2019

Last Updated

August 6, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Our regulations forbid to share the IPD

Locations