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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02853682
Other study ID # PI2015_843_0027
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 20, 2016
Est. completion date August 2018

Study information

Verified date August 2018
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 28
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- cardiac surgery

Exclusion Criteria:

- auricular fibrillation

- endocarditis

- aortic dissection

- end stage chronic renal disease

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
plasma
assesment of glycocalyx protein

Locations

Country Name City State
France CHU Amiens Picardie Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. Erratum in: J Am Coll Cardiol 2002 Mar 20;39(6):1082. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary glycocalyx proteins 1 proteoglycan in patient plasma is assayed. 48 hours
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