- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06285526
Glycocalyx Monitoring in Major Abdominal Surgery (GLYCOCHIP)
May 21, 2026 updated by: University Hospital, Rouen
Evaluation of Perioperative 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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
78
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rouen, France, 76000
- Rouen University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group HIPEC
Cytoreduction surgery with hyperthermic intraperitoneal chemotherapy (HIPEC)
|
Cytoreduction surgery with Hyperthermic Intraperitoneal Chemotherapy
Other Names:
|
|
Group CDP
Cephalic DuodenoPancreatectomy (CDP)
|
Cephalic DuodenoPancreatectomy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
between the day before the operation (Day -1) and the post-operative period (Day 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
post-operative period (Day 1)
|
|
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.
|
post-operative period (Day 1)
|
|
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.
|
post-operative period (Day 1)
|
|
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.
|
post-operative period (Day 1)
|
|
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
|
between Day -1 and Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zoé DEMAILLY, Dr, University Rouen Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 5, 2022
Primary Completion (Actual)
March 3, 2025
Study Completion (Actual)
May 13, 2026
Study Registration Dates
First Submitted
January 2, 2024
First Submitted That Met QC Criteria
February 22, 2024
First Posted (Actual)
February 29, 2024
Study Record Updates
Last Update Posted (Actual)
May 22, 2026
Last Update Submitted That Met QC Criteria
May 21, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Therapeutics
- Drug Therapy
- Nucleic Acids, Nucleotides, and Nucleosides
- Pyrimidines
- Hyperthermia, Induced
- Combined Modality Therapy
- Ribonucleotides
- Nucleotides
- Cytosine Nucleotides
- Pyrimidine Nucleotides
- Chemotherapy, Adjuvant
- Hyperthermic Intraperitoneal Chemotherapy
- Cytidine Diphosphate
Other Study ID Numbers
- 2023/0046/OB
- 2023-A00350-45 (Registry Identifier: French Minister)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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