Redo Cardiac SurgeryNCT03925376
Prognostic Factors of Patients Undergoing Redo Cardiac Surgery
An observational study of Redo Cardiac Surgery, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study aims to investigate the prognostic significance of baseline characteristics for patients undergoing redo cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Redo Cardiac Surgery
- What is being tested?
- Redo cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2019to 31 Dec 2024
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Redo cardiac surgery is associated with an increased risk of postoperative morbidity and mortality. Patients undergoing redo cardiac surgery are becoming increasingly complex due to multiple comorbidities, adherence of mediastinal structures to the undersurface of the sternum as well as the spatial location of patent bypass grafts relative to the route of entry.
Who may be able to join
- Patients undergoing redo cardiac surgery
Who cannot join
- Age <18 years;
- Patients with a DNR order or "do not escalate care" order.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan hospital, Fudan university
Shanghai, 200032
Guo-wei Tu, PhD, 86-021-64041990, tu.guowei@zs-hospital.sh.cn
Luo Zhe, PhD, 86-021-64041990, luo.zhe@zs-hospital.sh.cn
About this study
This study aims to investigate the prognostic significance of baseline characteristics for patients undergoing redo cardiac surgery.
Read the detailed description
Redo cardiac surgery is associated with an increased risk of postoperative morbidity and mortality. Patients undergoing redo cardiac surgery are becoming increasingly complex due to multiple comorbidities, adherence of mediastinal structures to the undersurface of the sternum as well as the spatial location of patent bypass grafts relative to the route of entry. Association estimates between baseline characteristics and outcomes in those cohort are imprecise. The aim of this study is to identify prognostic factors associated with redo cardiac surgery which may help physicians predict clinical outcomes and guide their treatment decision.
- Conditions
- Redo Cardiac Surgery
- Being tested
- Redo cardiac surgery
- Keywords
- Redo cardiac surgery, Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Redo cardiac surgeryProcedure or surgery
Redo cardiac surgery is technically challenging due to scarring of tissues resulting in loss of tissue planes, adhesions, multiple comorbid factors and risk of injury during re-entry.Suggested techniques in coronary artery surgery with a left internal mammary artery include routing the graft through a slit in the pericardium to minimize the possibility of adherence to the sternal table.
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Death from any cause at 28 days
Measured: 28 days
Secondary outcomes (1)
60- and 90-day mortality
Death from any cause at 60- and 90-days
Measured: 60 days and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start21 Apr 2019 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Redo Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925376
- Sponsor's protocol ID
- PURSUE
- Status last verified
- Apr 2019
- First submitted
- 19 Apr 2019
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors of Patients Undergoing Redo Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03925376
- Acronym / sponsor ID
- PURSUE
- Conditions
- Redo Cardiac Surgery
- Keywords
- Redo cardiac surgery, Outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 21 Apr 2019 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Apr 2019 (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.
This study aims to investigate the prognostic significance of baseline characteristics for patients undergoing redo cardiac surgery.
Detailed description
Redo cardiac surgery is associated with an increased risk of postoperative morbidity and mortality. Patients undergoing redo cardiac surgery are becoming increasingly complex due to multiple comorbidities, adherence of mediastinal structures to the undersurface of the sternum as well as the spatial location of patent bypass grafts relative to the route of entry. Association estimates between baseline characteristics and outcomes in those cohort are imprecise. The aim of this study is to identify prognostic factors associated with redo cardiac surgery which may help physicians predict clinical outcomes and guide their treatment decision.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Redo cardiac surgery is associated with an increased risk of postoperative morbidity and mortality. Patients undergoing redo cardiac surgery are becoming increasingly complex due to multiple comorbidities, adherence of mediastinal structures to the undersurface of the sternum as well as the spatial location of patent bypass grafts relative to the route of entry.
Key inclusion criteria (1 listed)
- Patients undergoing redo cardiac surgery
Key exclusion criteria (2 listed)
- Age <18 years;
- Patients with a DNR order or "do not escalate care" order.
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 |
|---|---|---|
| Redo cardiac surgeryRedo cardiac surgery is technically challenging due to scarring of tissues resulting in loss of tissue planes, adhesions, multiple comorbid factors and risk of injury during re-entry.Suggested techniques in coronary artery surgery with a left internal mammary artery include routing the graft through a slit in the pericardium to minimize the possibility of adherence to the sternal table. | Procedure or surgery | – |
Primary outcome
28-day mortality
Time frame: 28 days
Death from any cause at 28 days
1 secondary outcome
60- and 90-day mortality
Time frame: 60 days and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
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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.
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 Redo Cardiac Surgery, run by Shanghai Zhongshan Hospital at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 24 Apr 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: 28 days). 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 24 Apr 2019.