Coronary Artery Bypass GraftingCASUSNCT05026437
CASUS vs. APACHE II in Predicting Mortality After Coronary Artery Bypass Grafting
An observational study of Coronary Artery Bypass Grafting and Mortality, run by Antalya Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Grafting, Mortality
- What is being tested?
- Cardiac surgery score and APACHE II scoring
- How many people
- 204 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 Jan 2019to 10 Apr 2019
- How long will I take part?
- 1 Month
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population includes all adult patients who undergoing coronary artery bypass grafting during the study period.
Who may be able to join
- Undergoing coronary artery bypass grafting
- Over 18 years of age
- Staying at least 24 hours in the cardiac intensive care unit
Who cannot join
- Emergency surgery
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital in Turkey
Istanbul
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Istanbul
About this study
Official title: The Value of CASUS vs. APACHE II in Predicting Mortality Among Patients Undergoing Coronary Artery Bypass Grafting
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.
Read the 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.
- Conditions
- Coronary Artery Bypass Grafting, Mortality
- Being tested
- Cardiac surgery score and APACHE II scoring
- Keywords
- cardiac surgery score, mortality, ICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgery score and APACHE II scoringOther
Cardiac surgery score and APACHE II will calculated on the first postoperative day.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 7 days
Mortality in the first 7 days after surgery
Measured: 7 days
Mortality at 30 days
Mortality in the first 30 days after surgery
Measured: 30 days
Secondary outcomes (2)
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
Measured: Up to 3 months (Through study completion)
Length of the stay in the hospital
It includes the period from surgery to discharge
Measured: Up to 3 months (Through study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start2 Jan 2019
- Primary completion10 Mar 2019
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftingStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Haydarpasa Numune Training and Research Hospital
- Responsible party
- Principal investigator, Sumeyye Ugur, Haydarpasa Numune Training and Research Hospital
- Investigators
- Nihan YAPICI, Study director, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery TRHSümeyye UĞUR, Principal investigator, Haydarpaşa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026437
- Sponsor's protocol ID
- SU2019
- Acronym
- CASUS
- Status last verified
- Aug 2021
- First submitted
- 23 Jan 2019
- Last updated
- 30 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of CASUS vs. APACHE II in Predicting Mortality Among Patients Undergoing Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT05026437
- Acronym / sponsor ID
- CASUS / SU2019
- Conditions
- Coronary Artery Bypass Grafting, Mortality
- Keywords
- cardiac surgery score, mortality, ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Collaborators
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Haydarpasa Numune Training and Research Hospital
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 10 Mar 2019 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 30 Aug 2021 (actual)
- 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population includes all adult patients who undergoing coronary artery bypass grafting during the study period.
Key inclusion criteria (3 listed)
- Undergoing coronary artery bypass grafting
- Over 18 years of age
- Staying at least 24 hours in the cardiac intensive care unit
Key exclusion criteria (1 listed)
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgery score and APACHE II scoringCardiac surgery score and APACHE II will calculated on the first postoperative day. | Other | – |
Primary outcome
Mortality at 7 days
Time frame: 7 days
Mortality in the first 7 days after surgery
Mortality at 30 days
Time frame: 30 days
Mortality in the first 30 days after surgery
2 secondary outcomes
Length of stay in the cardiac intensive care unit
Time frame: Up to 3 months (Through study completion)
Length of the stay in the hospital
Time frame: Up to 3 months (Through study completion)
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 30 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Nihan YAPICI study director
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery TRH
Sümeyye UĞUR principal investigator
Haydarpaşa Numune Training and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Bypass Grafting and Mortality, run by Antalya Training and Research Hospital at 2 sites 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 3 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 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Mortality at 7 days (time frame: 7 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 30 Aug 2021.