- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02853682
Characterization of Endothelial Dysfunction as a Function of Hyperaemia of the Brachial Artery During Cardiac Surgery (GLYNO)
August 20, 2018 updated by: Centre Hospitalier Universitaire, Amiens
The glycocalyx is a layer of proteins and complex sugars covering the endothelium of vessels.
Its role as capillary filtration control is important.
In case of alteration of the glycocalyx, experimental models and some clinical studies show an increased capillary leak responsible for interstitial edema.
The analysis of glycocalyx in routine care is important to guide volume expansion.
Indeed, the literature provides evidence about the poor prognosis of excess water and its impact on organ.
This analysis challenge is to justify filling solution of choice according to the characteristic of this capillary leakage.
Study Overview
Detailed Description
Extra corporeal circulation and aortic clamp induce ischemia-reperfusion damages.
Vascular damages are represented by first glycocalyx, a layer of endovascular vessel proteoglycans, responsible for fluid permeability and secondly by nitro oxygen liberation responsible for vascular tonus.
The investigators suppose that both functions are impaired after cardiac surgery.
Study Type
Observational
Enrollment (Actual)
28
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
-
-
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Amiens, France, 80054
- CHU Amiens Picardie
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients going for cardiac surgery enrolled for 48 hours after surgery.
Description
Inclusion Criteria:
- cardiac surgery
Exclusion Criteria:
- auricular fibrillation
- endocarditis
- aortic dissection
- end stage chronic renal disease
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
presence of a vascular dysfunction
plasma
|
assesment of glycocalyx protein
|
absence of vascular dysfunction
plasma
|
assesment of glycocalyx protein
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
glycocalyx proteins 1
Time Frame: 48 hours
|
proteoglycan in patient plasma is assayed.
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Emmanuel LORNE, MD-PhD, CHU Amiens
- Principal Investigator: Pierre-Gregoire GUINOT, MD, CHU Amiens
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R; International Brachial Artery Reactivity Task Force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the International Brachial Artery Reactivity Task Force. J Am Coll Cardiol. 2002 Jan 16;39(2):257-65. doi: 10.1016/s0735-1097(01)01746-6. Erratum In: J Am Coll Cardiol 2002 Mar 20;39(6):1082.
- Becker BF, Jacob M, Leipert S, Salmon AH, Chappell D. Degradation of the endothelial glycocalyx in clinical settings: searching for the sheddases. Br J Clin Pharmacol. 2015 Sep;80(3):389-402. doi: 10.1111/bcp.12629. Epub 2015 May 22.
- Chawla LS, Ince C, Chappell D, Gan TJ, Kellum JA, Mythen M, Shaw AD; ADQI XII Fluids Workgroup. Vascular content, tone, integrity, and haemodynamics for guiding fluid therapy: a conceptual approach. Br J Anaesth. 2014 Nov;113(5):748-55. doi: 10.1093/bja/aeu298. Epub 2014 Sep 17.
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)
January 20, 2016
Primary Completion (Anticipated)
August 1, 2018
Study Completion (Anticipated)
August 1, 2018
Study Registration Dates
First Submitted
July 7, 2016
First Submitted That Met QC Criteria
July 29, 2016
First Posted (Estimate)
August 3, 2016
Study Record Updates
Last Update Posted (Actual)
August 21, 2018
Last Update Submitted That Met QC Criteria
August 20, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2015_843_0027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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