The Role of NEWS on Intensive Care Discharges | NCT03626961

Studies
The Role of NEWS on Intensive Care Discharges

NCT03626961

Sponsor

Hitit University

Status

Completed

Last Update Posted

Aug 6, 2019Actual

Enrollment

538Actual

Phase

Not provided

Conditions

Intensive Care

Interventions

readmission
discharge

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2017Actual

Primary Completion Date

Jan 1, 2019Actual

Completion Date

Jun 30, 2019Actual

First Submitted Date

Aug 8, 2018

First Submission Date that Met QC Criteria

Aug 8, 2018

First Posted Date

Aug 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2019

Last Update Posted Date

Aug 6, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

The Nationaly Early Warning Score (NEWS) is a single score based on the measurement of vital signs and inspired gases by the patient. A higher NEWS indicates severity of illness and risk of adverse outcomes. The use of NEWS values to select the appropriate patients for tertiary ICU discharges has not been tested. Our aim is to test the value of NEWS on discharges tertiary ICU.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

538Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
discharge		patients discharged from icu	Other: readmission Other: discharge
readmission		patients readmitted icu in 48 hours after icu discharge	Other: readmission Other: discharge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
readmission	Other	Readmission after 48 hours	discharge readmission

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Readmission rate	Clinical deterioration within 48 hours after ICU transfer	48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older than 18 years old
Stay higher than 48 hours

Exclusion Criteria:

Under 18 years old
Stay lower than 48 hours
Intoxication
Exitus

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ozgur Yagan, Assoc.Prof.	Hitit universtiy	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hitit university		Çorum	Çorum	19100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Our regulations forbid to share the IPD

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010359	Patient Readmission
D004322	Drainage

Ancestor Terms

ID	Term
D006760	Hospitalization
D005791	Patient Care
D013812	Therapeutics
D006296	Health Services

Browse Leaves

Not provided

Browse Branches

Not provided