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Completed

NCT Number: NCT06285526

Glycocalyx Monitoring in Major Abdominal Surgery

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.

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Key information

Conditions

Major Abdominal Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rouen University Hospital

Rouen, 76000, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy

Procedure

Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy

Other names: HIPEC

Cephalic DuodenoPancreatectomy

Procedure

Cephalic DuodenoPancreatectomy

Other names: CDP

Primary outcomes

  1. Glycocalyx thickness

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

    Perioperative variation in glycocalyx thickness (µm)

Secondary outcomes

  1. Glycocalyx thickness and a biological marker of tissue hypoperfusion

    Time frame: 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.

  2. Glycocalyx thickness and a biological marker of tissue hypoxia

    Time frame: post-operative period (Day 1)

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

  3. Blood cell velocity and macrocirculatory function

    Time frame: 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.

  4. Perfused capillary density and macrocirculatory function

    Time frame: 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.

  5. Variation of glycocalyx thickness and the daily entry-exit balance (BES) Day 1

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Evaluation of Perioperative Glycocalyx Monitoring in Major Abdominal Surgery

Acronym: GLYCOCHIP

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 29, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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