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Dry Weight Reduction Intervention Via Extra Ultrafiltration (DRIVE-UF)

3. juni 2026 opdateret af: Bryan Kestenbaum, University of Washington

Most patients who receive hemodialysis treatments have excess fluid in their body that has slowly built up over the course of kidney disease. This extra fluid is the main cause of high blood pressure in dialysis and leads to stress on the heart and lungs.that causes debilitating symptoms and frequent hospitalizations.

This trial will test whether a focused program of 4 or 8 weeks of extra ultrafiltration treatments can remove most of this extra fluid. We believe that getting rid of large amounts of extra fluid will result in sustained improvements in blood pressure and symptoms. Ultrafiltration is a gentler type of dialysis that removes fluid but does not clean the blood.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a randomized trial of patients who are receiving in-center hemodialysis treatments for end stage kidney disease and have clinical suspicion of fluid overload. Enrolled participants will be randomly assigned in 1:1:1 fashion to either a four-week ultrafiltration strategy, an eight-week ultrafiltration strategy, or continuation of their regular thrice weekly hemodialysis treatments. Each ultrafiltration strategy will add two extra four-hour ultrafiltration treatments per week plus pharmacist-guided tapering of blood pressure medications. We will test the impact of these strategies on primary outcomes of

  1. Change in 24-hour continuous ambulatory blood pressure from baseline to 24-weeks
  2. Change in symptoms of congestion from baseline to 24-weeks We will also test the impact of the treatment strategies on related symptoms, physical activity levels, hemodynamics. and measures of safety.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Ernest Ayers, MSPH
  • Telefonnummer: 206-685-1423
  • E-mail: ayerse@uw.edu

Undersøgelse Kontakt Backup

  • Navn: Luisa Rios-Avila
  • Telefonnummer: 206-258-9325
  • E-mail: lrios1@uw.edu

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98112
        • Northwest Kidney Centers
        • Kontakt:
          • Luisa Rios-Avila
          • Telefonnummer: 2062589325
          • E-mail: lrios1@uw.edu

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Receiving thrice weekly in-center hemodialysis treatments for end stage kidney disease for at least four weeks and clinical suspicion of volume excess based on either:

    1. Persistent hypertension defined by three consecutive pre-dialysis systolic blood pressures ≥140 mmHg or three consecutive pre-dialysis systolic blood pressures 130-140 mmHg plus use of at least two anti-hypertensive medications that can be tapered.

      OR

    2. Symptoms of congestion defined by a 12-item Kidney Modified Kansas City Cardiomyopathy Questionnaire (KM-KCCQ) score <75.

      Exclusion Criteria:

  • Age <18 years
  • Receiving hemodialysis treatments for acute kidney injury
  • Receiving hemodialysis treatments for less than four weeks
  • Planned switch to peritoneal or home dialysis within next three months
  • Current or planned incremental hemodialysis (less than 3 treatments per week)
  • Current or planned intensive hemodialysis (four or more treatments per week)
  • Scheduled kidney transplantation
  • Major cardiovascular or bleeding event within previous 90 days
  • Receiving chemotherapy or radiation treatment for cancer
  • History of cirrhosis with ascites
  • Inability to complete 24-hour ambulatory blood pressure measurement
  • Wheelchair dependance or other inability to complete six-minute walk test
  • Pre-dialysis systolic blood pressure <100 mmHg
  • Scheduled use of midodrine with hemodialysis treatments
  • History of non-adherence with dialysis treatments
  • Pregnancy
  • Institutionalized
  • Current or pending enrollment in hospice care
  • Inappropriate for enrollment based on investigator or nephrologist discretion

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Ultrafiltration sessions for 4 weeks
Two ultrafiltration sessions per week plus pharmacist guided tapering of blood pressure medications in addition to the regular thrice weekly hemodialysis treatments.
Procedure: Ultrafiltration
Ultrafiltration for 4 or 8 weeks compared to no ultrafiltration.
Aktiv komparator: Ultrafiltration sessions for 8 weeks
Two ultrafiltration sessions per week plus pharmacist guided tapering of blood pressure medications in addition to the regular thrice weekly hemodialysis treatments.
Procedure: Ultrafiltration
Ultrafiltration for 4 or 8 weeks compared to no ultrafiltration.
Ingen indgriben: Control arm, no ultrafiltration sessions
Participant receives only their regularly scheduled thrice weekly hemodialysis treatments.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
24-hour continuous ambulatory blood pressure
Tidsramme: Measurement performed at baseline compared to measurement performed at 24 weeks.
Blood pressure measured continously for a 24-hour period by wearing a blood pressure cuff on the upper arm.
Measurement performed at baseline compared to measurement performed at 24 weeks.
Symptoms of congestion.
Tidsramme: Questionnaire taken at Baseline compared the the questionnaire taken at 24 weeks.
Change in sypmtoms of congestion caused by fluid overload which we will access by using the Kidney-modified Kansas City Cardiomyopathy Questionnaire.
Questionnaire taken at Baseline compared the the questionnaire taken at 24 weeks.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Washington

Samarbejdspartnere

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Efterforskere

  • Ledende efterforsker: Bryan Kestenbaum, MD, MS, University of Washington

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. februar 2030

Studieafslutning (Anslået)

1. november 2030

Datoer for studieregistrering

Først indsendt

3. juni 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00025083
  • R01DK141693 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All data and samples will be stored indefinitely for possible future uses. There will be no direct or indirect identifiers stored with the resources after this study is finished.

Resources will be coded with study codes. We plan post de-identified data in public databases such as Dryad at study conclusion.

NIH data sharing policies typically require us to post coded, deidentified individual-level data on one of the preferred platforms. We will work with our NIH project officer to post data after the study is finished to an appropriate platform.

We may collaborate with colleagues and other researchers who demonstrate a legitimate research need for which data and samples from this study would be valuable.

Future uses do not have any restrictions.

IPD-delingstidsramme

We will share the study protocol, informed consent form, and statistical analysis plan at the beginning of the study and indefinitely. We will share the analytic code when it becomes available.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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