- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01468506
Ultrasound to Predict Steal-Syndrome After Arteriovenous-Fistula Creation (UPSAC - Trial) (UPSAC)
Studieoversikt
Status
Forhold
Detaljert beskrivelse
This is a prospective study where the research team will acquire data from the patients after they have signed the informed consent form. Data will be collected before, during and after the Arterio-Venous Fistula(AVF)placement, and during follow-up at predefined time intervals:Pre-Operative, Intra-operative, Post-operative, 5-10 days, 4-6 Weeks, 6 Months, and 1 year. These parameters include Digital Brachial Index (DBI) (assessed by Doppler derived brachial artery blood pressure/ photoplethysmographically derived finger blood pressure), flow and pulsatility measurements (derived by duplex ultrasound and pulse volume recording). Assessment of flow and pulsatility will be performed in the artery proximal and distal to the AVF, as well as in the venous outflow. In addition, Demographic parameters and patient comorbidities will be acquired and procedure specific parameters (e.g. location of the fistula) will be documented. During each follow up, clinical evaluation for Steal-Syndrome will be conducted. Steal-Syndrome was defined according to the guidelines of the Society of Vascular Surgery (SVS): Asymptomatic (pulse deficits, doppler signal attenuation, and distal flow reversal) Mild Ischemia: slight coldness and numbness that occurs only during dialysis, may be self-limited, and may resosolve without treatment, and Severe Ischemia: Can be permanent and may be associated with constant pain, severe numbness, digital cyanosis or gangrene, finger contracture, or amputation of a digit hand or forearm. The necessity for and type of re-intervention at the AVF will be documented. Acquisition of data will in no way change the standard of care used in these patients / operations.
Data analysis will be performed after enrolment of 100, 250 and 500 patients.
Studietype
Kontakter og plasseringer
Studiesteder
-
-
Florida
-
Miami, Florida, Forente stater, 33176
- Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients 18 years of age
- Autogenous, brachio-cephalic, brachio-basilic or brachio-brachial Arterio- Venous Fistula creation for hemodialysis
- General preoperative requirements for this surgery passed
- Patients willing to adhere to the follow-up
- Patients able to understand and provide informed consent
Exclusion Criteria:
- Less than 18 years of age
- Patient is unable or unwilling to provide consent
- Prosthetic graft creation
- Creation of a radio-cephalic AV-Fistula other than described in the inclusion criteria
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
---|
Fistula patients
Consecutive patients with autogenous, brachio-cephalic, brachio-basilic or brachio-brachial arterio-venous fistula creation for hemodialysis
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Steal-Syndrome
Tidsramme: 1 year
|
Steal Syndrome as defined according to the guidelines of the Society of Vascular Surgery (SVS): Asymptomatic (pulse deficits, doppler signal attenuation, and distal flow reversal) Mild Ischemia: slight coldness and numbness that occurs only during dialysis, may be self-limited, and may resosolve without treatment, and Severe Ischemia: Can be permanent and may be associated with constant pain, severe numbness, digital cyanosis or gangrene, finger contracture, or amputation of a digit hand or forearm.
Standard assessment for steal syndrom at 5-10 days, 4-6 weeks, 6 months, and 1 year.
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Time to fistula maturation
Tidsramme: 1 year
|
Time between fistula creation and time to clinical fistula maturation, standard assessment of fistula maturation at 5-10 days, 4-6 weeks, 6 months, and 1 year
|
1 year
|
Fistula patency
Tidsramme: 1 year
|
Time between fistula creation and time to first intervention to restore fistula function (operation, endovascular procedure)
|
1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Athanassios Tsoukas, MD, Baptist Hospital Miami, BCVI
- Hovedetterforsker: Heiko Uthoff, MD, Baptist Hospital Miami, BCVI
- Hovedetterforsker: Philipp Geisbuesch, MD, Baptist Hospital Miami, BCVI
- Studieleder: Raul Herrera, MD, Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute
- Hovedetterforsker: Barry Katzen, MD, Medical Director Baptist Cardiac and Vascular Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UPSAC version 17 Jul 2011
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