Microcirculation Evolution in Patients After Cardiac Surgery | NCT04461743

Studies
Microcirculation Evolution in Patients After Cardiac Surgery

NCT04461743

Sponsor

Southeast University, China

Status

Unknown status

Last Update Posted

Jul 8, 2020Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Patients After Cardiac Surgery

Interventions

No intervention

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

Jul 2020

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

Jun 4, 2020Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Jan 31, 2021Estimated

First Submitted Date

May 31, 2020

First Submission Date that Met QC Criteria

Jul 3, 2020

First Posted Date

Jul 8, 2020Actual

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

Jul 3, 2020

Last Update Posted Date

Jul 8, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jingyuan,Xu, Southeast University, China, Southeast University, ChinaPrincipal Investigator

Lead Sponsor

Southeast University, ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

We evaluated the impact on macrocirculatory hemodynamics and microcirculation in patients after cardiac surgery and compared the evolutions of those parameters between patients with tissue hypoperfusion and normal perfusion. Consecutive patients after cardiac surgery who required mechanical ventilation and for whom sublingual microcirculation measurements were possible enrolled.

Detailed Description

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with normal lac			Other: No intervention
Patients with abnormal lac			Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention, regular therapy	Patients with abnormal lac Patients with normal lac

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Microcirculation	PPV and MFI	Extubation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consecutive patients after cardiac surgery.
Patients whom sublingual microcirculation measurements were possible.

Exclusion Criteria:

moribund patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients after cardiac surgery who required mechanical ventilation and for whom sublingual microcirculation measurements were possible.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jingyuan Xu	Contact	8613851417209		xujingyuanmail@163.com

Overall Officials

Name	Affiliation	Role
Jingyuan Xu	Southeast University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Critical Care Medicine	Recruiting	Nanjing	Jiangsu	210009	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided