Correlation Between Access Blood Flow and Extracorporeal Blood Flow

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Instituto Nacional de Cardiologia Ignacio Chavez.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier:
NCT00522704
First received: August 28, 2007
Last updated: March 17, 2009
Last verified: March 2009
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Access Blood Flow and Extracorporeal Blood Flow

Resource links provided by NLM:


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

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:
    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.
    Other Name: BTM,
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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: Correlation between access blood flow and effective extracorporeal blood flow, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT00522704     History of Changes
Other Study ID Numbers: INCich-07-08-7403
Study First Received: August 28, 2007
Last Updated: March 17, 2009
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:
Arteriovenous Fistula
Fistula
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 20, 2014