Monitoring of Glycocalyx for Prediction of Complications... | NCT06136637

Studies
Monitoring of Glycocalyx for Prediction of Complications After Cardiac Surgery

NCT06136637

Sponsor

University Hospital, Rouen

Status

Recruiting

Last Update Posted

Jul 18, 2024Actual

Enrollment

77Estimated

Phase

Not provided

Conditions

Cardiac Surgery

Interventions

Not provided

Countries

France

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

ID	Type	Description	Link
2020/416/OB	Other Identifier	DRCI CHU Rouen

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Jul 1, 2026Estimated

Completion Date

Jul 1, 2026Estimated

First Submitted Date

Mar 29, 2023

First Submission Date that Met QC Criteria

Nov 14, 2023

First Posted Date

Nov 18, 2023Actual

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 17, 2024

Last Update Posted Date

Jul 18, 2024Actual

Name	Class
University of Rouen Normandie	OTHER

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

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.

Detailed Description

Not provided

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

77Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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

Adult patient undergoing cardiac surgery with cardiopulmonary bypass

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Demailly Zoé, MD	Contact	0232882440		zoe.demailly@chu-rouen.fr
DRCI Rouen	Contact	0232888265

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rouen University Hospital	Recruiting	Rouen			France