Correlation Between Access Blood Flow and Extracorporeal... | NCT00522704

Studies
Correlation Between Access Blood Flow and Extracorporeal Blood Flow

NCT00522704

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Status

Unknown status

Last Update Posted

Nov 6, 2014Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Arteriovenous Fistula

Interventions

Dynamic Arterial line Pressure (DALP)

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Apr 2015Estimated

Completion Date

Jun 2015Estimated

First Submitted Date

Aug 28, 2007

First Submission Date that Met QC Criteria

Aug 29, 2007

First Posted Date

Aug 30, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2014

Last Update Posted Date

Nov 6, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

FRANKLIN MORA, Doctor, Instituto Nacional de Cardiologia Ignacio ChavezPrincipal Investigator

Lead Sponsor

Instituto Nacional de Cardiologia Ignacio ChavezOTHER

Collaborators

Name	Class
JOSE CARRASCO ARTEAGA HOSPITAL FROM Ecuadorian Institute of Social Security	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.		BTM,

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acces Blood Flow	Acces Blood Flow: cuantity of Blood that Flow throw venous acces in ml/min	Acces Blood Flow

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Franklin B Mora, M.D.	Contact	593 72 868084		franklin.mora.bravo@gmail.com
Luis R Mariscal, M.D.	Contact	52 55 55 7932911	1262	mariscalmd@yahoo.com.mx

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Nacional De Cardiología Ignacio Chávez	Recruiting	Mexico City	Distrito Federeal	14080	Mexico

Condition Browse Module

MeSH Terms

ID	Term
D001164	Arteriovenous Fistula

Ancestor Terms

ID	Term
D001165	Arteriovenous Malformations
D054079	Vascular Malformations
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases

Browse Leaves

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Browse Branches

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