Clinical trial NCT06285526: Glycocalyx Monitoring in Major Abdominal Surgery
Official title: Evaluation of Perioperative Glycocalyx Monitoring in Major Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Major Abdominal Surgery
Keywords: Glycocalyx
Microcirculation
Cephalic DuodenoPancreatectomy
Hyperthermic Intraperitoneal Chemotherapy
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient undergoing major abdominal surgery by cytoreduction combined with an intraperitoneal chemotherapy bath (HIPEC) or cephalic duodeno-pancreatectomy (CDP) with epidural analgesia planned in accordance with the department's usual practice

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycocalyx thickness
timeFrame: between the day before the operation (Day -1) and the post-operative period (Day 1)
Secondary outcomes:
measure: Glycocalyx thickness and a biological marker of tissue hypoperfusion
timeFrame: post-operative period (Day 1)
measure: Glycocalyx thickness and a biological marker of tissue hypoxia
timeFrame: post-operative period (Day 1)
measure: Blood cell velocity and macrocirculatory function
timeFrame: post-operative period (Day 1)
measure: Perfused capillary density and macrocirculatory function
timeFrame: post-operative period (Day 1)
measure: Variation of glycocalyx thickness and the daily entry-exit balance (BES) Day 1
timeFrame: between Day -1 and Day 1
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Rouen Hospital
name: Zoé DEMAILLY, Dr
role: PRINCIPAL_INVESTIGATOR
References: