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Characterization of Endothelial Dysfunction as a Function of Hyperaemia of the Brachial Artery During Cardiac Surgery (GLYNO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02853682
Recruitment Status : Active, not recruiting
First Posted : August 3, 2016
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:
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.

Condition or disease Intervention/treatment
Capillary Leak Syndrome Biological: plasma

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.

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Endothelial Dysfunction as a Function of Hyperaemia of the Brachial Artery During Cardiac Surgery
Actual Study Start Date : January 20, 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
presence of a vascular dysfunction
plasma
Biological: plasma
assesment of glycocalyx protein

absence of vascular dysfunction
plasma
Biological: plasma
assesment of glycocalyx protein




Primary Outcome Measures :
  1. glycocalyx proteins 1 [ Time Frame: 48 hours ]
    proteoglycan in patient plasma is assayed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients going for cardiac surgery enrolled for 48 hours after surgery.
Criteria

Inclusion Criteria:

  • cardiac surgery

Exclusion Criteria:

  • auricular fibrillation
  • endocarditis
  • aortic dissection
  • end stage chronic renal disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853682


Locations
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France
CHU Amiens Picardie
Amiens, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Osama ABOU ARAB, MD CHU Amiens
Study Director: Emmanuel LORNE, MD-PhD CHU Amiens
Principal Investigator: Pierre-Gregoire GUINOT, MD CHU Amiens
Publications:
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02853682    
Other Study ID Numbers: PI2015_843_0027
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
glycocalyx
capillary leak syndrome
Additional relevant MeSH terms:
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Hyperemia
Capillary Leak Syndrome
Vascular Diseases
Cardiovascular Diseases