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Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis

8. december 2014 opdateret af: University of Michigan
The study is being performed to better understand dialysis techniques which keep heart functions stable during dialysis. People on dialysis have a high risk for heart disease and strokes. More information about dialysis techniques that keep hearts stable may help prevent the high risk of cardiovascular disease and death and help to reduce discomfort during dialysis. This study will look at the way that the magnesium in dialysate affects heart function during dialysis. High or low levels of magnesium may change the way hearts beat. The question asked is if lowering the amount of magnesium in dialysate will affect the amount of magnesium in blood or change the heart beat.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Heart disease is a major cause of illness and death among patients on dialysis. Changes in the heart's rhythm and sudden cardiac death are also important problems in this group. Abnormal rhythm can occur during hemodialysis.

During dialysis, the blood comes in contact with a solution called dialysate. This solution contains minerals like calcium, potassium and magnesium. Some studies have indirectly suggested that lower magnesium in dialysis patients protects them from having rhythm problems.

Factors that increase the chance for the development of abnormal rhythms can be indirectly assessed by evaluating the electrocardiogram (EKG). This is done by measuring the distance between the wave forms on the EKG. One of these is called the QT interval. QT dispersion is a value derived from the QT interval. A long QT interval is thought to make an individual more prone to having abnormal heart rhythms.

Therefore it is planned to study the effect of low levels of magnesium in the dialysate on QT interval and dispersion and the tendency for rhythm change. QT interval changes will be compared during dialysis with low magnesium with QT interval changes during dialysis with normal magnesium.

This will be a cross over trial including 24 adult male and female patients on chronic hemodialysis. Subjects will be studied during two of their regular dialysis sessions, the only difference being the amount of magnesium in the dialysate. QT interval and QT dispersion will be calculated from the EKG recordings before and after each dialysis session.

The results of this study will lead to a better understanding of cardiovascular risks in patients undergoing chronic dialysis and may offer a potentially novel strategy to reduce the risk of abnormal heart rhythms risk during dialysis.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

25

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48104
        • University of Michigan Dialysis Center
      • Livonia, Michigan, Forenede Stater, 48152
        • University of Michigan Dialysis Center

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 18 years of age and over with end-stage renal disease. (ESRD)
  • have been on maintenance hemodialysis therapy three times/week for greater than or equal to 3 months
  • All causes of renal failure are included

Exclusion Criteria:

  • less than 18 years of age
  • have been on maintenance hemodialysis therapy three times/week for less than 3 months
  • are pregnant or lactating
  • unable or unwilling to provide informed consent
  • currently participating in a clinical trial with an intervention
  • systolic (top number) blood pressure levels greater than or equal to 180 or less then 80
  • diastolic (bottom number) blood pressure levels greater than 110
  • a hemoglobin level (red blood cell measure) that is less than 8mg/dl
  • a corrected calcium level that is greater than 11mg/dl or less than 8mg/dl
  • had a change in their anti-hypertensive medications within the last three weeks
  • clinical signs and symptoms of untreated or unresolved infection
  • clinical evidence requiring admission to the hospital
  • had a cerebral vascular accident or myocardial incident within the past 3 months
  • Based on the assessment of the investigators, or study coordinator designee, patients who appear unlikely or unable to participate in the required study procedures
  • Patients with a history of arrhythmias, recent electrophysiological evaluation and or having pacemakers are excluded.
  • Patients with acute renal failure.

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: Ikke-randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The primary outcome is the difference in QT dispersion between low dialysate magnesium and normal dialysate magnesium
Tidsramme: over one dialysis session
measurement will be the duration of some changes in the EKG.
over one dialysis session

Samarbejdspartnere og efterforskere

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

Sponsor

University of Michigan

Samarbejdspartnere

Renal Research Institute

Efterforskere

  • Ledende efterforsker: Panduranga S Rao, MD, DNB, MS, University of Michigan

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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

1. november 2005

Primær færdiggørelse (Faktiske)

1. juni 2006

Studieafslutning (Faktiske)

1. november 2006

Datoer for studieregistrering

Først indsendt

17. oktober 2005

Først indsendt, der opfyldte QC-kriterier

17. oktober 2005

Først opslået (Skøn)

19. oktober 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. december 2014

Sidst verificeret

1. juli 2005

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DRDA 05-2076

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 .

Kliniske forsøg med Kronisk nyresygdom

Kliniske forsøg med Dialysate Magnesium (Concentration)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Romania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
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