CASUS vs. APACHE II in Predicting Mortality After Coronar... | NCT05026437

Studies
CASUS vs. APACHE II in Predicting Mortality After Coronary Artery Bypass Grafting

NCT05026437

Sponsor

Antalya Training and Research Hospital

Status

Completed

Last Update Posted

Aug 30, 2021Actual

Enrollment

204Actual

Phase

Not provided

Conditions

Coronary Artery Bypass Grafting
Mortality

Interventions

Cardiac surgery score and APACHE II scoring

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 2021

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

Jan 2, 2019Actual

Primary Completion Date

Mar 10, 2019Actual

Completion Date

Apr 10, 2019Actual

First Submitted Date

Jan 23, 2019

First Submission Date that Met QC Criteria

Aug 23, 2021

First Posted Date

Aug 30, 2021Actual

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 23, 2021

Last Update Posted Date

Aug 30, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sumeyye Ugur, drsumeyyeugur@gmail.com, Haydarpasa Numune Training and Research HospitalPrincipal Investigator

Lead Sponsor

Antalya Training and Research HospitalOTHER_GOV

Collaborators

Name	Class
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital	OTHER
Haydarpasa Numune Training and Research Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The study seeks to determine the value of CASUS in predicting mortality as compared with APACHE II scoring system among patients undergoing coronary artery bypass grafting.

Detailed Description

Patients undergoing coronary artery bypass grafting will prospectively studied after the admission to the cardiac intensive care unit. Data on the preoperative condition, intraoperative parameters, and postoperative course will collected. CASUS and APACHE II scores will calculated on the first postoperative day. Clinical outcomes are defined as 7-day mortality, 30-day mortality and morbidity. Morbidity includes variables such as length of stay in the cardiac surgical intensive care unit and in the hospital.

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

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

204Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac surgery score and APACHE II scoring	Other	Cardiac surgery score and APACHE II will calculated on the first postoperative day.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality at 7 days	Mortality in the first 7 days after surgery	7 days
Mortality at 30 days	Mortality in the first 30 days after surgery	30 days

Secondary Outcomes

Measure	Description	Time Frame
Length of stay in the cardiac intensive care unit	Only the length of the initial stay in the cardiac intensive care unit up to 3 months	Up to 3 months (Through study completion)
Length of the stay in the hospital

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Undergoing coronary artery bypass grafting
Over 18 years of age
Staying at least 24 hours in the cardiac intensive care unit

Exclusion Criteria:

Emergency surgery

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

Study population includes all adult patients who undergoing coronary artery bypass grafting during the study period.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nihan YAPICI	Dr. Siyami Ersek Thoracic and Cardiovascular Surgery TRH	Study Director
Sümeyye UĞUR	Haydarpaşa Numune Training and Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital in Turkey		Istanbul			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided