Correlation Between Access Blood Flow and Extracorporeal Blood Flow

Arteriovenous Fistula Clinical Trial

Official title:

Correlation Between Access Blood Flow and Extracorporeal Blood Flow

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00522704
• Other study ID #: INCich-07-08-7403
• Status: Recruiting
• Phase: N/A
• First received: August 28, 2007
• Last updated: November 4, 2014
• Start date: March 2008
• Est. completion date: June 2015

Study information

• Verified date: November 2014
• Source: Instituto Nacional de Cardiologia Ignacio Chavez
• Contact: Franklin B Mora, M.D.
• Phone: 593 72 868084
• Email: franklin.mora.bravo[@]gmail.com
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine if Effective Extracorporeal Blood Flow(eEBF) has correlation with Access Blood Flow (Qa), when eEBF adjusts with Dynamic Arterial Line Pressure (DALP) in patients with Arteriovenous fistulae in hemodialysis treatment.

Description:

Accesses that show a large (>15%) decrement over time in vascular access blood flow are associated with a high risk of thrombosis. Serial measurements of vascular access blood flow predict access thrombosis. At the moment, the measurement of access flow is time consuming, operator dependent, so that it cannot be done with every treatment. We hypothesized that extracorporeal blood flow at pressure of -200 to -260 mmHg in arterial line has correlation with access blood flow and this can be used to estimate access blood flow.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with Chronic Kidney Disease K-DIGO 5d in hemodialysis treatment)

• Permanent vascular accesses with native arteriovenous fistulas (AVF)

• AVF that were at least 12 weeks old

Exclusion Criteria:

• Inflammation and pain in AVF

• Negation to participate in the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arteriovenous Fistula

Intervention

Other:
• Dynamic Arterial line Pressure (DALP)
eEBF will be record with dynamic arterial line pressure of -60 mmHg (eEBF-60 mmHg), -100 mmHg (eEBF-100 mmHg), -160 mmHg (eEBF-160 mmHg), -200 mmHg (eEBF-200 mmHg) and -260 mmHg (eEBF-260 mmHg) during the first one half hour of the dialysis session. Access Blood flow will be performed with blood thermal monitor.

Locations

Country	Name	City	State
Mexico	Instituto Nacional De Cardiología Ignacio Chávez	Mexico City	Distrito Federeal

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Cardiologia Ignacio Chavez	JOSE CARRASCO ARTEAGA HOSPITAL FROM Ecuadorian Institute of Social Security

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acces Blood Flow	Acces Blood Flow: cuantity of Blood that Flow throw venous acces in ml/min	Acces Blood Flow	Yes