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

NCT ID: NCT02853682

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-20
• Study Completion Date: 2018-08-31

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.

Conditions

Capillary Leak Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

presence of a vascular dysfunction

plasma

plasma

Intervention Type: BIOLOGICAL

assesment of glycocalyx protein

absence of vascular dysfunction

plasma

plasma

Intervention Type: BIOLOGICAL

assesment of glycocalyx protein

Interventions

plasma

assesment of glycocalyx protein

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• cardiac surgery

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Osama ABOU ARAB, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Emmanuel LORNE, MD-PhD

Role: STUDY_DIRECTOR

CHU Amiens

Pierre-Gregoire GUINOT, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

CHU Amiens Picardie

Amiens, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 11788217 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25778676 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25231767 (View on PubMed)

Other Identifiers

PI2015_843_0027

Identifier Type: -

Identifier Source: org_study_id