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Correlation Between Access Blood Flow and Extracorporeal Blood Flow

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor:
Collaborator:
JOSE CARRASCO ARTEAGA HOSPITAL FROM Ecuadorian Institute of Social Security
Information provided by (Responsible Party):
FRANKLIN MORA, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier:
NCT00522704
First received: August 28, 2007
Last updated: November 4, 2014
Last verified: November 2014
  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:

Primary Outcome Measures:
  • Acces Blood Flow [ Time Frame: Acces Blood Flow ] [ Designated as safety issue: Yes ]
    Acces Blood Flow: cuantity of Blood that Flow throw venous acces in ml/min


Estimated Enrollment: 30
Study Start Date: March 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (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
JOSE CARRASCO ARTEAGA HOSPITAL FROM Ecuadorian Institute of Social Security
Investigators
Principal Investigator: Franklin B Mora, M.D. HOSPITAL JOSE CARRASCO ARTEAGA DEL INSTITUTO ECUATORIANO DE SEGURIDAD SOCIAL REGIONAL 3
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 Chair: Héctor G Pérez-Grovas, M.D. Instituto Nacional de Cardiología Ignacio Chávez
Principal Investigator: Fabián H Ortiz, MsC Hospital Clínica Kennedy, Guayaquil Ecuador
  More Information

No publications provided

Responsible Party: FRANKLIN MORA, Doctor, 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: November 4, 2014
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
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical
Vascular Diseases
Vascular Fistula
Vascular Malformations

ClinicalTrials.gov processed this record on November 24, 2014