Arteriovenous FistulaNCT00522704
Correlation Between Access Blood Flow and Extracorporeal Blood Flow
An observational study of Arteriovenous Fistula, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arteriovenous Fistula
- What is being tested?
- Dynamic Arterial line Pressure (DALP)
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2008to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Chronic Kidney Dissease K-DIGO 5d in hemodialysis.
Who may be able to join
- 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
Who cannot join
- Inflammation and pain in AVF
- Negation to participate in the study
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional De Cardiología Ignacio Chávez
Mexico City, Distrito Federeal, 14080
Luis R Mariscal, M.D., 52 55 557932911 ext. 1262, mariscalmd@yahoo.com.mx
Franklin B Mora, M.D.
About this study
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.
Read the 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.
- Conditions
- Arteriovenous Fistula
- Being tested
- Dynamic Arterial line Pressure (DALP)
- Keywords
- Arteriovenous fistula, Access blood flow, Extracorporeal blood flow, Dynamic arterial line pressure, Hemodialysis treatment
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Arterial line Pressure (DALP)Other
Also called BTM,
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acces Blood Flow
Acces Blood Flow: cuantity of Blood that Flow throw venous acces in ml/min
Measured: Acces Blood Flow
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startMar 2008
- Primary completionApr 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Collaborators
- JOSE CARRASCO ARTEAGA HOSPITAL FROM Ecuadorian Institute of Social Security
- Responsible party
- Principal investigator, FRANKLIN MORA, Instituto Nacional de Cardiologia Ignacio Chavez
- Investigators
- Franklin B Mora, M.D., Principal investigator, HOSPITAL JOSE CARRASCO ARTEAGA DEL INSTITUTO ECUATORIANO DE SEGURIDAD SOCIAL REGIONAL 3Luis R Mariscal, M.D., Study chair, Instituto Nacional de Cardiología Ignacio ChávezGuadalupe C De la Cruz, R.N., Study chair, Instituto Nacional de Cardiología Ignacio ChávezHéctor G Pérez-Grovas, M.D., Study chair, Instituto Nacional de Cardiología Ignacio ChávezFabián H Ortiz, MsC, Principal investigator, Hospital Clínica Kennedy, Guayaquil Ecuador
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522704
- Sponsor's protocol ID
- INCich-07-08-7403
- Status last verified
- Nov 2014
- First submitted
- 28 Aug 2007
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Access Blood Flow and Extracorporeal Blood Flow
- ClinicalTrials.gov ID
- NCT00522704
- Acronym / sponsor ID
- INCich-07-08-7403
- Conditions
- Arteriovenous Fistula
- Keywords
- Arteriovenous fistula, Access blood flow, Extracorporeal blood flow, Dynamic arterial line pressure, Hemodialysis treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Collaborators
- JOSE CARRASCO ARTEAGA HOSPITAL FROM Ecuadorian Institute of Social Security
- Study start
- Mar 2008
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 30 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Chronic Kidney Dissease K-DIGO 5d in hemodialysis.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Inflammation and pain in AVF
- Negation to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Arterial line Pressure (DALP)Also: BTM,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 | – |
Primary outcome
Acces Blood Flow
Time frame: Acces Blood Flow
Acces Blood Flow: cuantity of Blood that Flow throw venous acces in ml/min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franklin B Mora, M.D. principal investigator
HOSPITAL JOSE CARRASCO ARTEAGA DEL INSTITUTO ECUATORIANO DE SEGURIDAD SOCIAL REGIONAL 3
Luis R Mariscal, M.D. study chair
Instituto Nacional de Cardiología Ignacio Chávez
Guadalupe C De la Cruz, R.N. study chair
Instituto Nacional de Cardiología Ignacio Chávez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Fistula, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Franklin B Mora, M.D. (593 72 868084, franklin.mora.bravo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acces Blood Flow (time frame: Acces Blood Flow). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2014; AzTrials last refreshed its copy on 3 Nov 2026.