NCT00522704

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 6, 2014

Status Verified

November 1, 2014

Enrollment Period

7.1 years

First QC Date

August 28, 2007

Last Update Submit

November 4, 2014

Conditions

Arteriovenous Fistula

Keywords

Arteriovenous fistulaAccess blood flowExtracorporeal blood flowDynamic arterial line pressureHemodialysis treatment

Outcome Measures

Primary Outcomes (1)

  • Acces Blood Flow

    Acces Blood Flow: cuantity of Blood that Flow throw venous acces in ml/min

    Acces Blood Flow

Interventions

Dynamic Arterial line Pressure (DALP)OTHER

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.

Also known as: BTM,

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Inflammation and pain in AVF
  • Negation to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional De Cardiología Ignacio Chávez

Mexico City, Distrito Federeal, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Franklin B Mora, M.D.

    HOSPITAL JOSE CARRASCO ARTEAGA DEL INSTITUTO ECUATORIANO DE SEGURIDAD SOCIAL REGIONAL 3

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

  • Fabián H Ortiz, MsC

    Hospital Clínica Kennedy, Guayaquil Ecuador

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Franklin B Mora, M.D.

CONTACT

593 72 868084franklin.mora.bravo@gmail.com

Luis R Mariscal, M.D.

CONTACT

52 55 55 7932911mariscalmd@yahoo.com.mx

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 28, 2007

First Posted

August 30, 2007

Study Start

March 1, 2008

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

November 6, 2014

Record last verified: 2014-11

Locations

ME(1)