Correlation Between Access Blood Flow and Extracorporeal Blood Flow

This study is currently recruiting participants.

Verified by Instituto Nacional de Cardiologia Ignacio Chavez, March 2009

First Received: August 28, 2007 Last Updated: March 17, 2009 History of Changes

Sponsor:	Instituto Nacional de Cardiologia Ignacio Chavez
Information provided by:	Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier:	NCT00522704

Purpose

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.

Condition	Intervention
Arteriovenous Fistula	Other: Dynamic Arterial line Pressure (DALP)

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Correlation Between Access Blood Flow and Extracorporeal Blood Flow

Resource links provided by NLM:

MedlinePlus related topics: Fistulas

U.S. FDA Resources

Further study details as provided by Instituto Nacional de Cardiologia Ignacio Chavez:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	March 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with Chronic Kidney Dissease K-DIGO 5d in hemodialysis.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522704

Contacts

Contact: Franklin B Mora, M.D.	593 72 868084	franklin.mora.bravo@gmail.com
Contact: Luis R Mariscal, M.D.	52 55 55 7932911 ext 1262	mariscalmd@yahoo.com.mx

Locations

Mexico, Distrito Federeal
Instituto Nacional De Cardiología Ignacio Chávez	Recruiting
Mexico City, Distrito Federeal, Mexico, 14080
Contact: Luis R Mariscal, M.D. 52 55 557932911 ext 1262 mariscalmd@yahoo.com.mx
Principal Investigator: Franklin B Mora, M.D.
Sub-Investigator: Luis R Mariscal, M.D.

Sponsors and Collaborators

Instituto Nacional de Cardiologia Ignacio Chavez

Investigators

Principal Investigator:	Franklin B Mora, M.D.	Instituto Nacional de Cardiología Ignacio Chávez
Study Chair:	Luis R Mariscal, M.D.	Instituto Nacional de Cardiología Ignacio Chávez
Study Chair:	Guadalupe C De la Cruz, R.N.	Instituto Nacional de Cardiología Ignacio Chávez
Study Director:	Martha G Franco, M.D., PH.D.	Instituto Nacional de Cardiología Ignacio Chávez
Study Chair:	Héctor G Pérez-Grovas, M.D.	Instituto Nacional de Cardiología Ignacio Chávez
Study Chair:	Norma Venegas, M.D.	Centro de Hemodiálisis "Mansilla"-Buenos Aires.
Study Chair:	Carlos Z Najún, M.D.	Centro de Hemodiálisis-"Mansilla"-Buenos Aires

More Information

No publications provided

Responsible Party:	Instituto Nacional de Cardiologia Ignacio Chavez ( Correlation between access blood flow and effective extracorporeal blood flow )
Study ID Numbers:	INCich-07-08-7403
Study First Received:	August 28, 2007
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00522704 History of Changes
Health Authority:	Mexico: Ethics Committee

Keywords provided by Instituto Nacional de Cardiologia Ignacio Chavez:

Arteriovenous fistula
Access blood flow
Extracorporeal blood flow
Dynamic arterial line pressure
Hemodialysis treatment

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Cardiovascular Abnormalities
Arteriovenous Fistula
Vascular Fistula
Vascular Malformations

Vascular Diseases
Cardiovascular Diseases
Arteriovenous Malformations
Congenital Abnormalities
Fistula

ClinicalTrials.gov processed this record on November 27, 2009