Glycocalyx Monitoring in Major Abdominal Surgery

Recruiting

• Conditions: Major Abdominal Surgery
• Interventions: Procedure: Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy; Procedure: Cephalic DuodenoPancreatectomy

• Registration Number: NCT06285526
• Lead Sponsor: University Hospital, Rouen

Brief Summary

The study of the microcirculation and glycocalyx could be an essential element in the monitoring of our patients undergoing major abdominal surgery. It would enable us to better target the objectives of anaesthesia and resuscitation, which until now have been based essentially on macro-circulatory parameters.

Detailed Description

This monitoring is possible in real time and real conditions by micro-camera GlycoCheck™ (Microvascular Health Solutions Inc., Salt Lake City, Utah, USA), a non-invasive monitoring allowing the study of sublingual microcirculation and glycocalyx.

Study Timeline

• Study Start: 2022-07-05
• Status Verified: 2023-12
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-29
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Primary Completion: 2025-01-05
• Study Completion: 2025-01-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

For the HIPEC group :

• Adult patients
• Age < 75 years
• Receiving HIPEC for primary or secondary peritoneal carcinosis

For the CDP group :

• Adult patient
• Age < 75 years
• Receiving CDP for pancreatic neoplasia
• Patient who has read and understood the information letter and does not object to taking part in the study
• Patient affiliated to a social security scheme

Exclusion Criteria

• Secondary distant peritoneal metastases
• Chronic heart failure
• Chronic liver failure at stage C of the Child-Pugh score
• Stage IV or V chronic renal failure
• Inflammation of the sublingual buccal mucosa or injury that may locally influence sublingual microcirculation
• Patient refusal
• Person deprived of liberty by an administrative or judicial decision or person placed under court protection or guardianship

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group HIPEC	Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy	Cytoreduction surgery with hyperthermic intraperitoneal chemotherapy (HIPEC)
Group CDP	Cephalic DuodenoPancreatectomy	Cephalic DuodenoPancreatectomy (CDP)

Primary Outcome Measures

Name	Time	Method
Glycocalyx thickness	between the day before the operation (Day -1) and the post-operative period (Day 1)	Perioperative variation in glycocalyx thickness (µm)

Secondary Outcome Measures

Name	Time	Method
Glycocalyx thickness and a biological marker of tissue hypoperfusion	post-operative period (Day 1)	To assess, in each population ((HIPEC and CDC), the association between the thickness of the glycocalyx established by analysis of the sublingual microcirculation using GlycoCheck® and a biological marker of tissue hypoperfusion.
Glycocalyx thickness and a biological marker of tissue hypoxia	post-operative period (Day 1)	Establish the link between glycocalyx thickness and a biological marker of tissue hypoxia.
Blood cell velocity and macrocirculatory function	post-operative period (Day 1)	Assess the association between velocity of the red blood cells (µm/s) and cardiac index obtained by Most-Care® monitoring on Day 1.
Perfused capillary density and macrocirculatory function	post-operative period (Day 1)	Assess the association between perfused capillary density (mm/mm2) and cardiac index obtained by Most-Care® monitoring on Day 1.
Variation of glycocalyx thickness and the daily entry-exit balance (BES) Day 1	between Day -1 and Day 1	To assess the difference between water and fluid intake (perfusion, nutrition, drug dilution solution) and output (diuresis, digestive aspiration, diarrhoea) over 24 hours

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France