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Prognostic Factors of Patients Undergoing Redo Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03925376
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Study Description
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Brief Summary:
This study aims to investigate the prognostic significance of baseline characteristics for patients undergoing redo cardiac surgery.

Condition or disease Intervention/treatment
Redo Cardiac Surgery Procedure: 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
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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Factors of Patients Undergoing Redo Cardiac Surgery
Estimated Study Start Date : April 21, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Groups and Cohorts
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Intervention Details:
  • Procedure: Redo cardiac 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.

Outcome Measures
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Primary Outcome Measures :
  1. 28-day mortality [ Time Frame: 28 days ]
    Death from any cause at 28 days


Secondary Outcome Measures :
  1. 60- and 90-day mortality [ Time Frame: 60 days and 90 days ]
    Death from any cause at 60- and 90-days


Other Outcome Measures:
  1. Length of stay in the ICU [ Time Frame: up to 90 days ]
    the length of stay in the ICU

  2. Length of stay in the hospital [ Time Frame: up to 90 days ]
    the length of stay in the hospital

  3. Percentage of participants with adverse events [ Time Frame: up to 90 days ]
    Adverse events includes haemorrhage; need for intraoperative/postoperative intra-aortic balloon pumping (IABP); prolonged intubation; acute kidney injury or need for continuous renal replacement therapy (CRRT); poor neurological outcome; infection events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • Patients undergoing redo cardiac surgery

Exclusion Criteria:

  • Age <18 years;
  • Patients with a DNR order or "do not escalate care" order.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925376


Locations
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China
Zhongshan hospital, Fudan university Recruiting
Shanghai, China, 200032
Contact: Guo-wei Tu, PhD    86-021-64041990    tu.guowei@zs-hospital.sh.cn   
Contact: Luo Zhe, PhD    86-021-64041990    luo.zhe@zs-hospital.sh.cn   
Principal Investigator: Ying Su         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03925376    
Other Study ID Numbers: PURSUE
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Zhongshan Hospital:
Redo cardiac surgery
Outcome