Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-28 @ 5:57 PM
Study NCT ID:
NCT00522704
Status:
UNKNOWN
Last Update Posted:
2014-11-06
First Post:
2007-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Access Blood Flow and Extracorporeal Blood Flow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-04', 'studyFirstSubmitDate': '2007-08-28', 'studyFirstSubmitQcDate': '2007-08-29', 'lastUpdatePostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acces Blood Flow', 'timeFrame': 'Acces Blood Flow', 'description': 'Acces Blood Flow: cuantity of Blood that Flow throw venous acces in ml/min'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Arteriovenous fistula', 'Access blood flow', 'Extracorporeal blood flow', 'Dynamic arterial line pressure', 'Hemodialysis treatment'], 'conditions': ['Arteriovenous Fistula']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Chronic Kidney Dissease K-DIGO 5d in hemodialysis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Chronic Kidney Disease K-DIGO 5d in hemodialysis treatment)\n* Permanent vascular accesses with native arteriovenous fistulas (AVF)\n* AVF that were at least 12 weeks old\n\nExclusion Criteria:\n\n* Inflammation and pain in AVF\n* Negation to participate in the study'}, 'identificationModule': {'nctId': 'NCT00522704', 'briefTitle': 'Correlation Between Access Blood Flow and Extracorporeal Blood Flow', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Cardiologia Ignacio Chavez'}, 'officialTitle': 'Correlation Between Access Blood Flow and Extracorporeal Blood Flow', 'orgStudyIdInfo': {'id': 'INCich-07-08-7403'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dynamic Arterial line Pressure (DALP)', 'type': 'OTHER', 'otherNames': ['BTM,'], 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14080', 'city': 'Mexico City', 'state': 'Distrito Federeal', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Luis R Mariscal, M.D.', 'role': 'CONTACT', 'email': 'mariscalmd@yahoo.com.mx', 'phone': '52 55 557932911', 'phoneExt': '1262'}, {'name': 'Franklin B Mora, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Luis R Mariscal, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Instituto Nacional De Cardiología Ignacio Chávez', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Franklin B Mora, M.D.', 'role': 'CONTACT', 'email': 'franklin.mora.bravo@gmail.com', 'phone': '593 72 868084'}, {'name': 'Luis R Mariscal, M.D.', 'role': 'CONTACT', 'email': 'mariscalmd@yahoo.com.mx', 'phone': '52 55 55 7932911', 'phoneExt': '1262'}], 'overallOfficials': [{'name': 'Franklin B Mora, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HOSPITAL JOSE CARRASCO ARTEAGA DEL INSTITUTO ECUATORIANO DE SEGURIDAD SOCIAL REGIONAL 3'}, {'name': 'Luis R Mariscal, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto Nacional de Cardiología Ignacio Chávez'}, {'name': 'Guadalupe C De la Cruz, R.N.', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto Nacional de Cardiología Ignacio Chávez'}, {'name': 'Héctor G Pérez-Grovas, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto Nacional de Cardiología Ignacio Chávez'}, {'name': 'Fabián H Ortiz, MsC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clínica Kennedy, Guayaquil Ecuador'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Cardiologia Ignacio Chavez', 'class': 'OTHER'}, 'collaborators': [{'name': 'JOSE CARRASCO ARTEAGA HOSPITAL FROM Ecuadorian Institute of Social Security', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'FRANKLIN MORA', 'investigatorAffiliation': 'Instituto Nacional de Cardiologia Ignacio Chavez'}}}}