Prognostic Factors of Patients Undergoing Redo Cardiac Su... | NCT03925376

Studies
Prognostic Factors of Patients Undergoing Redo Cardiac Surgery

NCT03925376

Sponsor

Shanghai Zhongshan Hospital

Status

Unknown status

Last Update Posted

Apr 24, 2019Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Redo Cardiac Surgery

Interventions

Redo cardiac surgery

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 21, 2019Estimated

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Apr 19, 2019

First Submission Date that Met QC Criteria

Apr 23, 2019

First Posted Date

Apr 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2019

Last Update Posted Date

Apr 24, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Redo cardiac surgery	Procedure	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing redo cardiac surgery

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan hospital, Fudan university	Recruiting	Shanghai		200032	China