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:
Instituto Nacional de Cardiologia Ignacio Chavez
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
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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:
Genetics Home Reference related topics:
capillary malformation-arteriovenous malformation syndrome
Parkes Weber syndrome
MedlinePlus related topics:
Fistulas
U.S. FDA Resources
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:
Detailed Description:
-
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,
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
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 Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities |
Fistula Pathological Conditions, Anatomical Vascular Diseases Vascular Fistula Vascular Malformations |
ClinicalTrials.gov processed this record on February 27, 2015