- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05264402
Comparison of Early Phase Infections Risk Between Midline and Piccline Caheters: MIDLINE AND PICCLINE CATHETERS (PICCORMID)
A long-term venous access is frequently required in patient management. Currently, it is ensured by using the long peripheral intravenous catheters (Midline) or peripheral inserted central catheters (PICC line). Either is inserted into a peripheral vein of the upper arm and extends to the distal axillary vein.
If the indications for the two catheters can sometimes be debated, the Midline catheter seems to be more and more used. The complications related to the use of PICC lines have been well described in literature, whereas the comparison of the two catheter-related complications has been less analysed.
The aim of this study is to compare the incidences of catheter-related bloodstream infections linked to PICCs and Midlines.
Studieoversikt
Status
Detaljert beskrivelse
This single-center observational study will record and compare Midline and PICC line catheter-related bloodstream infections in the first 30 days after placement, catheter-related bloodstream infections being defined as clinical signs associated with a positive catheter culture (bacterial culture finding more than 103 CFU/mL) without any other infectious entry points.
Catheter indications, insertion conditions, incidence of haemorrhagic and thrombotic complications during the first 30 days will be analyzed.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: AnaÏS CAILLARD
- Telefonnummer: 02 98 34 72 88
- E-post: anais.caillard@chu-brest.fr
Studer Kontakt Backup
- Navn: Brigitte HUIBAN
- E-post: brigitte.huiban@chu-brest.fr
Studiesteder
-
-
-
Brest, Frankrike, 29609
- Rekruttering
- CHRU de Brest
-
Ta kontakt med:
- Anais CAILLARD
- E-post: anais.caillard@chu-brest.fr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Major ≥ 18 years old
- opposition formulated
Exclusion Criteria:
- Refusal of participation
- Patients under legal protection (guardianship, curatorship, etc.)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
PICCline group
Patients needing a vascular approach using PICCline catheters
|
|
Midline group
Patients needing a vascular approach using Midline catheters
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Compared rate of catheter-related bloodstream infections in the first 30 days in Midline and PICCline group. Catheter-related bloodstream infections are defined as clinical signs with a positive catheter culture without any other infectious entry points.
Tidsramme: first 30 days after placement
|
catheter-related bloodstream infections being defined as clinical signs (fever, swelling, pain) associated with a positive catheter culture (bacterial culture finding more than 103 CFU/mL) without any other infectious entry points. the number of infections recorded will be compared between the group of patients having a Midline and the group of patients having a PICCline |
first 30 days after placement
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
catheter placement time will be evaluated in days
Tidsramme: first 30 days after placement
|
catheter placement time will be evaluted by measuring the time between catheter placement and removal in days
|
first 30 days after placement
|
|
rate of no infection complications like obstruction, accidental removal, thrombosis, hemorrhagic complications
Tidsramme: first 30 days
|
The number of mechanical compliaction (obstruction, accidental removal, etc.), haemorrhagic and thrombotic complications recorded will be compared between the group of patients having a Midline and the group of patients having a PICCline
|
first 30 days
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PICCORMID (29BRC21.0288)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .