NCT06136637

Brief Summary

This is a prospective observational study of the evolution of the microcirculation and the sublingual glycocalyx in perioperative cardiac surgery under cardiopulmonary bypass. Our main objective is to evaluate the prognostic value of the variation of the thickness of the perioperative glycocalyx for the occurrence of a major complication in the first 24 hours after surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress96%
Jun 2022Jul 2026

Study Start

First participant enrolled

June 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2023

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

4.1 years

First QC Date

March 29, 2023

Last Update Submit

July 17, 2024

Conditions

Cardiac Surgery

Keywords

GlycocalyxMicrocirculationCardiopulmonary bypassOrgan failure

Outcome Measures

Primary Outcomes (1)

  • Glycocalyx thickness variation

    Change in glycocalyx thickness between the preoperative period and the postoperative period (2 hours after the end of cardiopulmonary bypass).

    Two hours after the end of cardiopulmonarybypass

Eligibility Criteria

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

Adult patient undergoing cardiac surgery with cardiopulmonary bypass

* Patient of legal age (age ≥ 18 years) * Patient undergoing scheduled cardiac surgery with cardiopulmoary bypass (CPB) (expected duration of CPB \> 60 min) * Person informed with collection of non-opposition at the latest, the day before the operation - Person affiliated to a social security system

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, France

RECRUITING

Central Study Contacts

Demailly Zoé, MD

CONTACT

0232882440zoe.demailly@chu-rouen.fr

DRCI Rouen

CONTACT

0232888265

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2023

First Posted

November 18, 2023

Study Start

June 1, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

July 18, 2024

Record last verified: 2024-07

Locations

FR(1)