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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Prognostic Factors of Patients Undergoing Redo Cardiac Surgery

Clinicaltrials.gov identifier NCT03925376

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted April 24, 2019

Study Description

Brief summary:

This study aims to investigate the prognostic significance of baseline characteristics for patients undergoing redo cardiac surgery.

  • Condition or Disease:Redo Cardiac Surgery
  • Intervention/Treatment: Procedure: Redo cardiac surgery
  • Phase: N/A
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
  • 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 2019
  • Estimated Primary Completion Date: December 2024
  • Estimated Study Completion Date: December 2024
Outcome Measures
  • 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
  • Ages Eligible for Study: 18 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
Contacts
Locations

China
Zhongshan hospital, Fudan university
Shanghai

Sponsors and Collaborators

Shanghai Zhongshan Hospital

More Information
  • Responsible Party: Shanghai Zhongshan Hospital
  • ClinicalTrials.gov Identifier: NCT03925376 History of Changes
  • Other Study ID Numbers: PURSUE
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: April 24, 2019
  • Last Verified: April 2019
  • 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