Glycocalyx Monitoring in Major Abdominal Surgery

Major Abdominal Surgery Clinical Trial

— GLYCOCHIP  

Official title:

Evaluation of Perioperative Glycocalyx Monitoring in Major Abdominal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06285526
• Other study ID #: 2023/0046/OB
• Secondary ID: 2023-A00350-45
• Status: Recruiting
• Start date: July 5, 2022
• Est. completion date: January 5, 2025

Study information

• Verified date: December 2023
• Source: University Hospital, Rouen
• Contact: Zoé DEMAILLY, Dr
• Phone: 02 32 88 24 40
• Email: Zoe.Demailly[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 5, 2025
• Est. primary completion date: July 5, 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Major Abdominal Surgery

Intervention

Procedure:
• Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy
Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy
• Cephalic DuodenoPancreatectomy
Cephalic DuodenoPancreatectomy

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycocalyx thickness	Perioperative variation in glycocalyx thickness (µm)	between the day before the operation (Day -1) and the post-operative period (Day 1)
Secondary	Glycocalyx thickness and a biological marker of tissue hypoperfusion	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.	post-operative period (Day 1)
Secondary	Glycocalyx thickness and a biological marker of tissue hypoxia	Establish the link between glycocalyx thickness and a biological marker of tissue hypoxia.	post-operative period (Day 1)
Secondary	Blood cell velocity and macrocirculatory function	Assess the association between velocity of the red blood cells (µm/s) and cardiac index obtained by Most-Care® monitoring on Day 1.	post-operative period (Day 1)
Secondary	Perfused capillary density and macrocirculatory function	Assess the association between perfused capillary density (mm/mm2) and cardiac index obtained by Most-Care® monitoring on Day 1.	post-operative period (Day 1)
Secondary	Variation of glycocalyx thickness and the daily entry-exit balance (BES) 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	between Day -1 and Day 1