Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001077550
Ethics application status
Approved
Date submitted
12/07/2024
Date registered
5/09/2024
Date last updated
5/09/2024
Date data sharing statement initially provided
5/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Outcome of in-hospital cardiac arrests (IHCAs) in a tertiary teaching hospital.
Scientific title
Outcome of in-hospital cardiac arrests (IHCAs) in AHEPA University Hospital in 1000 patients, all of whom received cardiopulmonary resuscitation by health care staff.
Secondary ID [1] 312477 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Arrest 334333 0
In-hospital Cardiac Arrest 334334 0
Condition category
Condition code
Emergency medicine 330987 330987 0 0
Resuscitation
Cardiovascular 331413 331413 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this observational retrospective study was to investigate the outcome of patients who suffered in hospital cardiac arrest (IHCA) in AHEPA University Hospital.
1000 patients who suffered IHCA from 01.01.2016 to 31.12.2022 are included in this study. All of them received cardiopulmonary resuscitation (CPR) performed by physicians and nurses of the hospital. After corresponding approval of the hospitals' ethics committee, data was retrieved by the local registry for IHCA which is kept by the hospital. Data collection started on 01.05.2024 and was completed on 30.06.2024. All IHCAs were reported according to the Utstein guidelines for IHCAs.
Intervention code [1] 328997 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338749 0
Return of Spontaneous Circulation
Timepoint [1] 338749 0
At the end of the cardiopulmonary resuscitation effort.
Primary outcome [2] 338750 0
Hospital lenght of stay
Timepoint [2] 338750 0
At hospital discharge
Secondary outcome [1] 437277 0
Neurological outcome
Timepoint [1] 437277 0
At hospital discharge, Six months after discharge, One year after discharge
Secondary outcome [2] 437278 0
Survival at six months
Timepoint [2] 437278 0
At six months after hospital discharge
Secondary outcome [3] 437279 0
Survival at 1 year
Timepoint [3] 437279 0
At one year after hospital discharge

Eligibility
Key inclusion criteria
Hospitalized patients suffering IHCA from 01.01.2016 to 31.12.2022 are included in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for this study are patients who suffered CA out of AHEPA Hospital and were transferred to the hospital by Emergency Medical Services either under CPR or with return of spontaneous circulation (ROSC).
Moreover, exclusion criteria are also patients who suffered IHCA but were NOT hospitalized such as visitors or relatives.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2024
Date of last participant enrolment
Anticipated
Actual
30/06/2024
Date of last data collection
Anticipated
Actual
30/06/2024
Sample size
Target
1000
Accrual to date
Final
1000
Recruitment outside Australia
Country [1] 26410 0
Greece
State/province [1] 26410 0

Funding & Sponsors
Funding source category [1] 316895 0
Self funded/Unfunded
Name [1] 316895 0
Country [1] 316895 0
Primary sponsor type
Hospital
Name
AHEPA University Hospital
Address
Country
Greece
Secondary sponsor category [1] 319196 0
None
Name [1] 319196 0
Address [1] 319196 0
Country [1] 319196 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315657 0
Ethics Committee of AHEPA University Hospital
Ethics committee address [1] 315657 0
Ethics committee country [1] 315657 0
Greece
Date submitted for ethics approval [1] 315657 0
09/04/2024
Approval date [1] 315657 0
19/04/2024
Ethics approval number [1] 315657 0
Ethics committee name [2] 315694 0
Hospital Executive Board
Ethics committee address [2] 315694 0
Ethics committee country [2] 315694 0
Greece
Date submitted for ethics approval [2] 315694 0
09/04/2024
Approval date [2] 315694 0
30/04/2024
Ethics approval number [2] 315694 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135398 0
A/Prof Barbara Fyntanidou
Address 135398 0
St. Kyriakidi 1 / 54636 / Thessaloniki / AHEPA University Hospital
Country 135398 0
Greece
Phone 135398 0
+30 6977 427336
Fax 135398 0
Email 135398 0
[email protected]
Contact person for public queries
Name 135399 0
Barbara Fyntanidou
Address 135399 0
St. Kyriakidi 1 / 54636 / Thessaloniki / AHEPA University Hospital
Country 135399 0
Greece
Phone 135399 0
+30 6977 427336
Fax 135399 0
Email 135399 0
[email protected]
Contact person for scientific queries
Name 135400 0
Barbara Fyntanidou
Address 135400 0
St. Kyriakidi 1 / 54636 / Thessaloniki / AHEPA University Hospital
Country 135400 0
Greece
Phone 135400 0
+30 2313 303631
Fax 135400 0
Email 135400 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.