SASH: Sodium Accumulation Study In Haemodialysis (SASH)
16. november 2021 oppdatert av: Nicholas Selby, University Hospitals of Derby and Burton NHS Foundation Trust
Sodium Accumulation Study In Haemodialysis
Haemodialysis (HD) sustains life in patients with end-stage kidney disease (ESKD) but is associated with a marked increase in incidence of cardiovascular disease (CVD) and high annual mortality rates.
The pathogenesis of CVD in patients on HD is multifactorial and complex but hypertension is thought to be a major contributing factor.
Sodium balance is normally regulated by the kidneys in health but has to be achieved by sodium removal during HD for those with ESKD.
Recent evidence suggests that accumulation of sodium in the skin and / or muscle may be a critical factor impacting the development of hypertension and CVD in patients with ESKD and non-invasive methods are therefore required to study tissue sodium accumulation in this context.
This study aims to determine the change in skin and muscle sodium content in patients undergoing haemodialysis.
Participants will have a single haemodialysis session, and undergo two MRI scans (one prior to and one following dialysis).
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
It has been proposed that tissue sodium accumulation in skin and/or muscle is a key factor in hypertension. 23Na MRI allows the assessment of skin and muscle sodium storage and will therefore be a valuable tool in elucidating the role of tissue sodium accumulation in the pathogenesis of salt-sensitive hypertension and cardiovascular morbidity and mortality. Moreover, if haemodialysis in patients with end-stage kidney disease (ESKD) results in changes in tissue sodium, the development of 23Na skin and muscle measures would allow for a method to correlate skin tissue sodium content with detailed cardiovascular and functional assessments.
Participants will have a single haemodialysis session, and undergo two MRI scans (one prior to and one following dialysis), in conjunction with clinical data collection (eg. blood samples, bioimpedance analysis, skin autoflorescence).
Studietype
Observasjonsmessig
Registrering (Forventet)
5
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Rebecca Noble, Dr
- Telefonnummer: 01332340131
- E-post: mszran@exmail.nottingham.ac.uk
Studiesteder
-
-
-
Derby, Storbritannia, DE22 3NE
- University Hospitals of Derby and Burton NHS Foundation Trust
-
Ta kontakt med:
- Nicholas Selby, Professor
- E-post: nicholas.selby@nottingham.ac.uk
-
Ta kontakt med:
- Rebecca Noble, Dr
- E-post: Rebecca.Noble1@nottingham.ac.uk
-
Hovedetterforsker:
- Nicholas Selby, Professor
-
Underetterforsker:
- Maarten Taal, Professor
-
Underetterforsker:
- Sue Francis, Professor
-
Underetterforsker:
- Ben Prestwich, Mr
-
Underetterforsker:
- Rebecca Noble, Dr
-
Underetterforsker:
- Kelly White, Miss
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
5 participants will be recruited from the renal unit
Beskrivelse
Inclusion Criteria:
- Age 50-75 years inclusive
- Male patients with CKD stage 5 receiving chronic haemodialysis
- Patient has been dialysis dependent for at least 3 months
- Must be able to follow simple instruction in English (on safety ground for MRI scans) and be able to understand the nature and requirements of the study
Exclusion Criteria:
- Active infection or malignancy
- Amputee
- Pregnancy
- Contraindication to MRI scanning including claustrophobia, pacemaker, metallic implants etc
- Unable or unwilling to provide informed consent
- Medical conditions or overall physical frailty precludes scan session in opinion of investigator
- Any condition which could interfere with the patient's ability to comply with the study
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Patients on haemodialysis
5 patients on haemodialysis will be recruited.
The study involves a single dialysis session and two MRI scans (one prior and one following dialysis) and collection of clinical data.
|
No intervention will be given in this study
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Ascertainment of MRI measures of skin and muscle sodium content in 100% of patients studied
Tidsramme: 6 months
|
Sodium imaging of the skin and muscle of the upper calf will be performed using a range of sequences to quantify sodium in the skin and muscle using both fast-field-echo (FFE) and ultrashort TE (UTE) imaging techniques.
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
To study skin and muscle sodium in haemodialysis patients and compare with previously reported healthy normal values
Tidsramme: 6 months
|
Sodium imaging of the skin and muscle of the upper calf will be performed using a range of sequences to quantify sodium in the skin and muscle using both fast-field-echo (FFE) and ultrashort TE (UTE) imaging techniques
|
6 months
|
|
To measure degree of change in skin and muscle sodium content in relation to a single haemodialysis treatment
Tidsramme: 6 months
|
Quantification of sodium in skin and muscle and compare finding before and after dialysis
|
6 months
|
|
To determine associations between skin and muscle sodium content and blood pressure, and change in skin and muscle sodium content with ultrafiltration volume and plasma-dialysate sodium gradient
Tidsramme: 6 months
|
By clinical data collection before, during and after dialysis
|
6 months
|
|
To determine associations between skin and muscle sodium content and cardiac function as determined by left ventricular mass (LVM) pressure
Tidsramme: 6 months
|
MRI abdominal coil will be used to collect cardiac MRI scans
|
6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Nicholas Selby, Professor, University Hospitals of Derby and Burton NHS Foundation Trust
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
15. januar 2022
Primær fullføring (Forventet)
15. mai 2022
Studiet fullført (Forventet)
15. juni 2022
Datoer for studieregistrering
Først innsendt
5. november 2021
Først innsendt som oppfylte QC-kriteriene
16. november 2021
Først lagt ut (Faktiske)
19. november 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. november 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. november 2021
Sist bekreftet
1. november 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UHDB/2021/020
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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. .