Prognostic Factors of Patients Undergoing Redo Cardiac Surgery

April 23, 2019 updated by: Shanghai Zhongshan Hospital
This study aims to investigate the prognostic significance of baseline characteristics for patients undergoing redo cardiac surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Patients undergoing redo cardiac surgery

Exclusion Criteria:

  • Age <18 years;
  • Patients with a DNR order or "do not escalate care" order.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day mortality
Time Frame: 28 days
Death from any cause at 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
60- and 90-day mortality
Time Frame: 60 days and 90 days
Death from any cause at 60- and 90-days
60 days and 90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay in the ICU
Time Frame: up to 90 days
the length of stay in the ICU
up to 90 days
Length of stay in the hospital
Time Frame: up to 90 days
the length of stay in the hospital
up to 90 days
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
up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 21, 2019

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

April 19, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 24, 2019

Study Record Updates

Last Update Posted (Actual)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PURSUE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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