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Correlation Between Access Blood Flow and Extracorporeal Blood Flow

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ClinicalTrials.gov Identifier: NCT00522704
Recruitment Status : Unknown
Verified November 2014 by FRANKLIN MORA, Instituto Nacional de Cardiologia Ignacio Chavez.
Recruitment status was:  Recruiting
First Posted : August 30, 2007
Last Update Posted : November 6, 2014
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

Brief 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.

Condition or disease Intervention/treatment
Arteriovenous Fistula Other: Dynamic Arterial line Pressure (DALP)

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.

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Access Blood Flow and Extracorporeal Blood Flow
Study Start Date : March 2008
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources


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,


Primary Outcome Measures :
  1. Acces Blood Flow [ Time Frame: Acces Blood Flow ]
    Acces Blood Flow: cuantity of Blood that Flow throw venous acces in ml/min



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 30, 2007    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 2014

Keywords provided by FRANKLIN MORA, Instituto Nacional de Cardiologia Ignacio Chavez:
Arteriovenous fistula
Access blood flow
Extracorporeal blood flow
Dynamic arterial line pressure
Hemodialysis treatment

Additional relevant MeSH terms:
Fistula
Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities