Heart DiseasesNCT01782716
Effect of Different Scoring Systems on Mortality Rates and Length of Hospitalization in Cardiac Surgery Patients
An observational study of Heart Diseases, run by Cumhuriyet University Hospital.
Trial summary
Precise risk estimation of mortality in cardiac surgery patients is often difficult. Main objectives of this study is to calculate mortality probability by two different risk score system and to inquire effects of informing anesthesiologist and surgical team; of score of the patient; on length of hospitalization and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Diseases
- How many people
- 438 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to May 2012
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac surgery patients
Who may be able to join
- ASA anesthesia risk group 2-5 patients between 18-70 years of age and with planned cardiac surgery
Who cannot join
- Terminal malignant diagnosis, multiple organ failure, confirmed brain dead, mechanical ventilation dependent or planned transplantation patients
About this study
Precise risk estimation of mortality in cardiac surgery patients is often difficult. Main objectives of this study is to calculate mortality probability by two different risk score system and to inquire effects of informing anesthesiologist and surgical team; of score of the patient; on length of hospitalization and intensive care and also on actualized mortality.
- Conditions
- Heart Diseases
- Keywords
- Mortality, Length, hospitalization, cardiac surgery, patients
- Medical subject headings
- Heart Diseases
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 |
|---|---|---|
| ASA | Not described | |
| ASA+Euroscore | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of days the patients treated
Measured: 30 days
mortality
Measured: With in the 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Cemil Isbir, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782716
- Sponsor's protocol ID
- Other Identifier-2011/037
- Status last verified
- Dec 2011
- First submitted
- 30 Jan 2013
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Scoring Systems on Mortality Rates and Length of Hospitalization in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT01782716
- Acronym / sponsor ID
- Other Identifier-2011/037
- Conditions
- Heart Diseases
- Keywords
- Mortality, Length, hospitalization, cardiac surgery, patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Cumhuriyet University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 4 Feb 2013 (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.
Precise risk estimation of mortality in cardiac surgery patients is often difficult. Main objectives of this study is to calculate mortality probability by two different risk score system and to inquire effects of informing anesthesiologist and surgical team; of score of the patient; on length of hospitalization and intensive care and also on actualized mortality.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASA | – | – |
| ASA+Euroscore | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac surgery patients
Key inclusion criteria (1 listed)
- ASA anesthesia risk group 2-5 patients between 18-70 years of age and with planned cardiac surgery
Key exclusion criteria (1 listed)
- Terminal malignant diagnosis, multiple organ failure, confirmed brain dead, mechanical ventilation dependent or planned transplantation patients
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
The number of days the patients treated
Time frame: 30 days
mortality
Time frame: With in the 30 days after surgery
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 4 Feb 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases, run by Cumhuriyet University Hospital.
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 1 inclusion and 1 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 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The number of days the patients treated (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2013.