Study of the Glycocalyx in Abdominal Aortic Aneurysm

Surgery Clinical Trial

— Endo_eAAA  

Official title:

Measurement of the Endothelial Function in Patients With a Abdominal Aortic Aneurism.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01834092
• Other study ID #: H-4-2012-085
• Status: Recruiting
• Phase: N/A
• First received: April 13, 2013
• Last updated: April 16, 2013
• Start date: April 2013
• Est. completion date: July 2014

Study information

• Verified date: April 2013
• Source: Rigshospitalet, Denmark
• Contact: Thomas B Jørgensen, MD
• Phone: +4535458734
• Email: thomas.bech.aaa[@]gmail.com
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators want to measure the degradation of the endothelial glycocalyx before and after clamping the aorta, in patients operated for a abdominal aortic aneurism.

Description:

50 patients is scheduled for enrollment. Blood samples will be up taken before surgery, 10 min after reperfusion, at the end of surgery and the following morning. In addition the investigators are placing a renal venous catheter where blood samples will be up taken as mentioned above for the analysis of endothelial markers together with markers for kidney damage.

The first 10 patient will act as part of a pilot study, where only measurement of the endothelial and renal failure markers will be performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• above 18 years

Exclusion Criteria:

• prior engagement in scientific study within the last 30 days.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abdominal Aortic Aneurism
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Ischemic Reperfusion Injury
• Reperfusion Injury
• Surgery

Intervention

Other:
• Plasma
2 Units of plasma transfused equvilant to 2 times 275ml

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Østerbro

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative organ failure	Development of kidney- and respiratory failure and sepsis	30 days	No
Primary	Endothelial dysfunction	Measurement of endothelial markers peri- and postoperative: thrombomodulin, E-selectin and syndecan-1	24 hours	No
Secondary	Fluid balance	Perioperative and postoperative first 24 hours	24 hours	No