Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001370392
Ethics application status
Approved
Date submitted
12/07/2017
Date registered
27/09/2017
Date last updated
27/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
2-Year Cerebral Performance Categories According To Initial Rhythm And Resuscitation Time Following In-Hospital Cardiac Arrest
Scientific title
2-Year Cerebral Performance Category at Hospital Discharge According To Initial Rhythm And Resuscitation Time
Secondary ID [1] 292422 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
In-Hospital Cardiac Arrest 304016 0
Two-Year Cerebral Performance Categories 304152 0
Condition category
Condition code
Neurological 303345 303345 0 0
Other neurological disorders
Cardiovascular 303346 303346 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
44 patients whose spontaneous circulation returned by in-hospital CPR. The patients survived for at least 24 h and were discharged after the treatment in Konya Numune Hospital between June 2011 and June 2013. The CPC values of these patients were followed up for 2 years after discharge. Subjects who were younger than 18 years died before discharge from the hospital and hence were excluded from the study.
In-hospital resuscitation for these patients was performed in accordance with current advanced life support protocols (2010 European Resuscitation Council Guideline). Demographic data, such as age and sex of the cases and clinical parameters related to CPR, were recorded.
Neurological results were assessed according to the CPC 13 by calling patients or their relatives at the 6th, 12th, 18th, and 24th months after discharge from the hospital. For the ones who did not give enough information, the follow-up information was obtained from the doctors who worked for "home health services." The information obtained from the doctors and patient’s relatives was evaluated by the neurology specialist. CPC 1 and 2 were classified as favorable neurological outcomes, whereas CPC 3, 4, and 5 were evaluated as poor outcomes.
Intervention code [1] 298594 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302734 0
Initial cardiac rhythm assessed using ECG
Timepoint [1] 302734 0
At return to spontaneous circulation.
Primary outcome [2] 302935 0
The resuscitation time assessed by review of medical record review
Timepoint [2] 302935 0
At return to spontaneous circulation.
Primary outcome [3] 302936 0
Cerebral Performance Category (CPC)
Timepoint [3] 302936 0
At 6, 12, 18 and 24 months post discharge.
Secondary outcome [1] 336859 0
none
Timepoint [1] 336859 0
none

Eligibility
Key inclusion criteria
-age greater than or equal to 18 years
- spontaneous circulation returned by in-hospital CPR following admission for cardiac arrest,
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- spontaneous circulation did not return by in-hospital CPR following admission for cardiac arrest,

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
The analysis of the study was made using the SPSS 20.0 software (SPSS, IL, USA). Continuous and categorical variables were presented in tables and graphs by subtracting descriptive measures. Continuous variables were expressed as mean ± standard deviation and median (min-max), whereas categorical variables were expressed as frequencies and percentage ratios. Cross tables were prepared, and the chi-square test was used to determine the relation between categorical variables. A P value less than 0.05 was considered statistically significant for all analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2011
Date of last participant enrolment
Anticipated
Actual
1/06/2013
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
44
Accrual to date
Final
44
Recruitment outside Australia
Country [1] 9049 0
Turkey
State/province [1] 9049 0

Funding & Sponsors
Funding source category [1] 296976 0
Hospital
Name [1] 296976 0
Konya Numune State Hospital
Country [1] 296976 0
Turkey
Funding source category [2] 296978 0
University
Name [2] 296978 0
Selcuk University
Country [2] 296978 0
Turkey
Primary sponsor type
Hospital
Name
Konya Numune State Hospital
Address
Yazir mah Turgut Ozal cad 3/999 Selcuklu-Konya
post code:42080
Country
Turkey
Secondary sponsor category [1] 296569 0
University
Name [1] 296569 0
Selcuk University
Address [1] 296569 0
Yazir mah Turgut Ozal cad 3/999 Selcuklu-Konya
post code:42080
Country [1] 296569 0
Turkey
Other collaborator category [1] 279739 0
None
Name [1] 279739 0
none
Address [1] 279739 0
none
Country [1] 279739 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298179 0
Selcuk University Faculty of Medicine Ethical Committee
Ethics committee address [1] 298179 0
Selcuk University Faculty of Medicine, School of Medicine, Kampus-Konya
Ethics committee country [1] 298179 0
Turkey
Date submitted for ethics approval [1] 298179 0
01/03/2017
Approval date [1] 298179 0
01/04/2017
Ethics approval number [1] 298179 0
2017-100

Summary
Brief summary
This study aimed to compare the cerebral performance category (CPC) scores of patients with the initial rhythm and resuscitation time for in-hospital cardiopulmonary arrest (CPA) during the 2-year period after discharge. A successful resuscitation should be in the form of both heart and brain resuscitation. The best postresuscitation measurement includes an evaluation of brain functions.
Trial website
Trial related presentations / publications
Trial is in evaluation process
Public notes
We thought that ethical approval was not necessary because it was an observational study.

Contacts
Principal investigator
Name 76234 0
A/Prof Faruk Cicekci
Address 76234 0
Selcuk University, Medical Faculty, Anesthesiology and Animation , Kampus-Selcuklu
postcode:42250 Konya
Country 76234 0
Turkey
Phone 76234 0
+905067649235
Fax 76234 0
Email 76234 0
[email protected]
Contact person for public queries
Name 76235 0
A/Prof Inci kara
Address 76235 0
Selcuk University, Medical Faculty, anesthesiology, Kampus-Konya
post code:42250
Country 76235 0
Turkey
Phone 76235 0
+905054831819
Fax 76235 0
Email 76235 0
[email protected]
Contact person for scientific queries
Name 76236 0
A/Prof Inci Kara
Address 76236 0
Selcuk University, Medical Faculty, anesthesiology, Kampus-Konya
post code:42250
Country 76236 0
Turkey
Phone 76236 0
+905057649235
Fax 76236 0
Email 76236 0
[email protected]

No information has been provided regarding IPD availability


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
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