NCT04461743

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

June 4, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

May 31, 2020

Last Update Submit

July 3, 2020

Conditions

Keywords

microcirculationcardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Microcirculation

    PPV and MFI

    Extubation

Study Arms (2)

Patients with normal lac

Other: No intervention

Patients with abnormal lac

Other: No intervention

Interventions

No intervention, regular therapy

Patients with abnormal lacPatients with normal lac

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • moribund patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Critical Care Medicine

Nanjing, Jiangsu, 210009, China

RECRUITING

Study Officials

  • Jingyuan Xu

    Southeast University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Southeast University, China

Study Record Dates

First Submitted

May 31, 2020

First Posted

July 8, 2020

Study Start

June 4, 2020

Primary Completion

December 31, 2020

Study Completion

January 31, 2021

Last Updated

July 8, 2020

Record last verified: 2020-07

Locations