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

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Unknown status
CT.gov ID
NCT02853682
Collaborator
(none)
28
1
30.4
0.9

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Jan 20, 2016
Anticipated Primary Completion Date :
Aug 1, 2018
Anticipated Study Completion Date :
Aug 1, 2018

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. glycocalyx proteins 1 [48 hours]

    proteoglycan in patient plasma is assayed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • cardiac surgery
Exclusion Criteria:
  • auricular fibrillation

  • endocarditis

  • aortic dissection

  • end stage chronic renal disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Picardie Amiens France 80054

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Osama ABOU ARAB, MD, CHU Amiens
  • Study Director: Emmanuel LORNE, MD-PhD, CHU Amiens
  • Principal Investigator: Pierre-Gregoire GUINOT, MD, CHU Amiens

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT02853682
Other Study ID Numbers:
  • PI2015_843_0027
First Posted:
Aug 3, 2016
Last Update Posted:
Aug 21, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2018