Glycocalyx Monitoring in Major Abdominal Surgery

University Hospital, Rouen100 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Major Abdominal Surgery

Interventions

Cytoreduction surgery with Hyperthermic Intraperitoneal ChemotherapyPROCEDURE

Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy

Cephalic DuodenoPancreatectomyPROCEDURE

Cephalic DuodenoPancreatectomy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Rouen University Hospital

Rouen, France

RECRUITING

Outcomes

Primary Outcomes

Glycocalyx thickness

Perioperative variation in glycocalyx thickness (µm)

Time frame: between the day before the operation (Day -1) and the post-operative period (Day 1)

Secondary Outcomes

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.

Time frame: post-operative period (Day 1)

Glycocalyx thickness and a biological marker of tissue hypoxia

Establish the link between glycocalyx thickness and a biological marker of tissue hypoxia.

Time frame: post-operative period (Day 1)

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.

Time frame: post-operative period (Day 1)

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.

Time frame: post-operative period (Day 1)

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

Time frame: between Day -1 and Day 1

Central Contacts

Zoé DEMAILLY, Dr

CONTACT

02 32 88 24 40 Zoe.Demailly@chu-rouen.fr

Emmanuel BESNIER, Pr

CONTACT

02 32 88 82 92 Emmanuel.Besnier@chu-rouen.fr

Data from ClinicalTrials.gov

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