- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00522704
Correlation Between Access Blood Flow and Extracorporeal Blood Flow
November 4, 2014 updated by: FRANKLIN MORA, Instituto Nacional de Cardiologia Ignacio Chavez
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Distrito Federeal
-
Mexico City, Distrito Federeal, Mexico, 14080
- Recruiting
- Instituto Nacional de Cardiologia Ignacio Chavez
-
Contact:
- Luis R Mariscal, M.D.
- Phone Number: 1262 52 55 557932911
- Email: mariscalmd@yahoo.com.mx
-
Principal Investigator:
- Franklin B Mora, M.D.
-
Sub-Investigator:
- Luis R Mariscal, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Chronic Kidney Dissease K-DIGO 5d in hemodialysis.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acces Blood Flow
Time Frame: Acces Blood Flow
|
Acces Blood Flow: cuantity of Blood that Flow throw venous acces in ml/min
|
Acces Blood Flow
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 Cardiologia Ignacio Chavez
- Study Chair: Guadalupe C De la Cruz, R.N., Instituto Nacional de Cardiologia Ignacio Chavez
- Study Chair: Héctor G Pérez-Grovas, M.D., Instituto Nacional de Cardiologia Ignacio Chavez
- Principal Investigator: Fabián H Ortiz, MsC, Hospital Clínica Kennedy, Guayaquil Ecuador
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Anticipated)
April 1, 2015
Study Completion (Anticipated)
June 1, 2015
Study Registration Dates
First Submitted
August 28, 2007
First Submitted That Met QC Criteria
August 29, 2007
First Posted (Estimate)
August 30, 2007
Study Record Updates
Last Update Posted (Estimate)
November 6, 2014
Last Update Submitted That Met QC Criteria
November 4, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INCich-07-08-7403
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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