Cardiac ArrestNCT02585050
Influences of DNAR Order Prohibition on Hospital Discharged Ratios and Neurological Outcomes at Discharge
An observational study of Cardiac Arrest, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Debates about the official and legal implementation of Do not attempt resuscitation (DNAR) orders are ongoing. The aim of this study was to determinate factors that influence neurological outcomes at discharge and the ratio of living patients discharged from the hospital due to DNAR prohibition. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Cardiac Arrest
- How many people
- 266 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2010to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CPR call forms that were completed.
Who may be able to join
- Patients experienced inhospital CPR attempts due to cardiac arrest
- Patients who did not have DNAR orders
Who cannot join
- Patients below 18 years of age
- Calls performed due to code blue drills
- Missing calls
- Patients with more than one cardiac arrest
- Patients with CPR attempts that began outside the hospital who were admitted to the emergency department.
- Patients with missing the data in hospital medical records.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adiyaman University Research Hospital
Adıyaman, Central, 02000
About this study
Debates about the official and legal implementation of Do not attempt resuscitation (DNAR) orders are ongoing. The aim of this study was to determinate factors that influence neurological outcomes at discharge and the ratio of living patients discharged from the hospital due to DNAR prohibition.
Read the detailed description
Study Design and Setting:
This is a single-center, retrospective chart review performed in a 180-bed rural city hospital.
Methods of Measurements:
Study was conducted as retrospective chart review of CPR call forms that were completed between February 2010 and February 2012. Approximately 450,000 patients were annually admitted to this hospital; 1800 patients were hospitalized in wards, and 500 patients were hospitalized in intensive care units during the study period. A form termed the CPR call form is completed by the leader of the CPR team at the end of all calls. These forms are filed in the hospital archive in chronological order. The hospital uses the resuscitation guidelines from the American Heart Association, and all healthcare providers of the CPR team are certified in basic cardiac life support (BCLS) and advanced cardiovascular life support (ACLS).
Study Population The data were collected from the CPR call forms and hospital medical records. All data were noted by using the Utstein-style reporting template and included the demographic data (date of birth/age and gender), date of arrest, time of first CPR attempt, etiology, preexisting conditions, location of arrest, arrest witnessed (a witnessed cardiac arrest is one that is observed or heard by another person or an arrest that is monitored), initial rhythm, duration of CPR attempt, end of event, date of discharge or death and neurological outcomes at discharge from the hospital.
CPR attempts were defined as an attempt to restore spontaneous circulation by performing chest compressions with or without ventilation. ROSC was defined by a status in which spontaneous circulation was sustained for at least 20 minutes.
Neurological outcomes at discharge were determined with a Cerebral Performance Category (CPC) score based on the last neurological examination of the patients before discharge. CPC scores of 1 or 2 were considered good neurological outcomes, and CPC scores of 3, 4 and 5 were considered poor neurological outcomes.
Data Analysis The continuous variables are expressed as the means and SD. The categorical data are expressed as percentages. Chi-square tests were used for the univariate analyses of categorical variables. Statistical significance was defined as p<0.05. The data were analyzed with SPSS v. 17.0.
- Conditions
- Cardiac Arrest
- Keywords
- do not attempt resuscitation, neurological outcome, live discharged ratio
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients alive discharged from hospital | patients alive discharged from hospital following CPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine survival rate from data obtained by retrospective chart review of patients who have not DNAR order and performed CPR due to cardiac arrest in the period 2010-2012
Data obtained by retrospective chart review will data including etiology, preexisting conditions, initial rhythm, end of event (any return of spontaneous circulation or not) live or death at discharged from hospital.
Measured: Two years
Secondary outcomes (1)
Examine the influence on neurological outcomes at discharge of DNAR order prohibition from data obtained by retrospective chart review.
Data obtained by retrospective chart review will data including neurological outcomes at discharge from the hospital.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umut Gulacti, Adiyaman University Research Hospital
- Investigators
- Umut Gulacti, M.D., Principal investigator, Adiyaman University of Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585050
- Sponsor's protocol ID
- ADYU 2
- Status last verified
- Oct 2015
- First submitted
- 21 Oct 2015
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Field RA, Fritz Z, Baker A, Grove A, Perkins GD. Systematic review of interventions to improve appropriate use and outcomes associated with do-not-attempt-cardiopulmonary-resuscitation decisions. Resuscitation. 2014 Nov;85(11):1418-31. doi: 10.1016/j.resuscitation.2014.08.024. Epub 2014 Sep 4.
PubMed 25195071
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influences of DNAR Order Prohibition on Hospital Discharged Ratios and Neurological Outcomes at Discharge
- ClinicalTrials.gov ID
- NCT02585050
- Acronym / sponsor ID
- ADYU 2
- Conditions
- Cardiac Arrest
- Keywords
- do not attempt resuscitation, neurological outcome, live discharged ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Debates about the official and legal implementation of Do not attempt resuscitation (DNAR) orders are ongoing. The aim of this study was to determinate factors that influence neurological outcomes at discharge and the ratio of living patients discharged from the hospital due to DNAR prohibition.
Detailed description
Study Design and Setting:
This is a single-center, retrospective chart review performed in a 180-bed rural city hospital.
Methods of Measurements:
Study was conducted as retrospective chart review of CPR call forms that were completed between February 2010 and February 2012. Approximately 450,000 patients were annually admitted to this hospital; 1800 patients were hospitalized in wards, and 500 patients were hospitalized in intensive care units during the study period. A form termed the CPR call form is completed by the leader of the CPR team at the end of all calls. These forms are filed in the hospital archive in chronological order. The hospital uses the resuscitation guidelines from the American Heart Association, and all healthcare providers of the CPR team are certified in basic cardiac life support (BCLS) and advanced cardiovascular life support (ACLS).
Study Population The data were collected from the CPR call forms and hospital medical records. All data were noted by using the Utstein-style reporting template and included the demographic data (date of birth/age and gender), date of arrest, time of first CPR attempt, etiology, preexisting conditions, location of arrest, arrest witnessed (a witnessed cardiac arrest is one that is observed or heard by another person or an arrest that is monitored), initial rhythm, duration of CPR attempt, end of event, date of discharge or death and neurological outcomes at discharge from the hospital.
CPR attempts were defined as an attempt to restore spontaneous circulation by performing chest compressions with or without ventilation. ROSC was defined by a status in which spontaneous circulation was sustained for at least 20 minutes.
Neurological outcomes at discharge were determined with a Cerebral Performance Category (CPC) score based on the last neurological examination of the patients before discharge. CPC scores of 1 or 2 were considered good neurological outcomes, and CPC scores of 3, 4 and 5 were considered poor neurological outcomes.
Data Analysis The continuous variables are expressed as the means and SD. The categorical data are expressed as percentages. Chi-square tests were used for the univariate analyses of categorical variables. Statistical significance was defined as p<0.05. The data were analyzed with SPSS v. 17.0.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients alive discharged from hospital | – | –patients alive discharged from hospital following CPR |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CPR call forms that were completed.
Key inclusion criteria (2 listed)
- Patients experienced inhospital CPR attempts due to cardiac arrest
- Patients who did not have DNAR orders
Key exclusion criteria (6 listed)
- Patients below 18 years of age
- Calls performed due to code blue drills
- Missing calls
- Patients with more than one cardiac arrest
- Patients with CPR attempts that began outside the hospital who were admitted to the emergency department.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Examine survival rate from data obtained by retrospective chart review of patients who have not DNAR order and performed CPR due to cardiac arrest in the period 2010-2012
Time frame: Two years
Data obtained by retrospective chart review will data including etiology, preexisting conditions, initial rhythm, end of event (any return of spontaneous circulation or not) live or death at discharged from hospital.
1 secondary outcome
Examine the influence on neurological outcomes at discharge of DNAR order prohibition from data obtained by retrospective chart review.
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
- Results publication: PubMed 25195071Field RA, Fritz Z, Baker A, Grove A, Perkins GD. Systematic review of interventions to improve appropriate use and outcomes associated with do-not-attempt-cardiopulmonary-resuscitation decisions. Resuscitation. 2014 Nov;85(11):1418-31. doi: 10.1016/j.resuscitation.2014.08.024. Epub 2014 Sep 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umut Gulacti, M.D. principal investigator
Adiyaman University of Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine survival rate from data obtained by retrospective chart review of patients who have not DNAR order and performed CPR due to cardiac arrest in the period 2010-2012 (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02585050, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2015.