Clinical trial NCT02853682: Characterization of Endothelial Dysfunction as a Function of Hyperaemia of the Brachial Artery During Cardiac Surgery
Official title: Characterization of Endothelial Dysfunction as a Function of Hyperaemia of the Brachial Artery During Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Capillary Leak Syndrome
Keywords: glycocalyx
capillary leak syndrome
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients going for cardiac surgery enrolled for 48 hours after surgery.

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.

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.

Eligibility criteria: Inclusion Criteria:

* cardiac surgery

Exclusion Criteria:

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

Primary outcomes:
measure: glycocalyx proteins 1
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
affiliation: CHU Amiens
name: Osama ABOU ARAB, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Emmanuel LORNE, MD-PhD
role: STUDY_DIRECTOR
affiliation: CHU Amiens
name: Pierre-Gregoire GUINOT, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s0735-1097(01)01746-6.
citation: 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.
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.