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

NCT02853682 | Unknown DMC

• 1 other identifier: PI2015_843_0027
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Capillary Leak Syndrome

Keywords

glycocalyx; capillary leak syndrome

Outcome Measures

Primary Outcomes (1)

• glycocalyx proteins 1

  proteoglycan in patient plasma is assayed.

  48 hours

Study Arms (2)

presence of a vascular dysfunction

plasma

Biological: plasma

absence of vascular dysfunction

plasma

Biological: plasma

Interventions

plasma BIOLOGICAL

assesment of glycocalyx protein

absence of vascular dysfunction; presence of a vascular dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients going for cardiac surgery enrolled for 48 hours after surgery.

You may qualify if:

• cardiac surgery

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, 80054, France

Location

Related Publications (3)

• 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.

  PMID: 11788217 BACKGROUND

• 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.

  PMID: 25778676 BACKGROUND

• 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.

  PMID: 25231767 BACKGROUND

MeSH Terms

Conditions

Capillary Leak Syndrome

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Osama ABOU ARAB, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Emmanuel LORNE, MD-PhD

  CHU Amiens

  STUDY DIRECTOR

• Pierre-Gregoire GUINOT, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: August 3, 2016
• Study Start: January 20, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)