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Sympathetic Activity in Patients With End-stage Renal Disease on Peritoneal Dialysis (SAPD)

11. mars 2021 oppdatert av: Dr. Marcel Ruzicka, Ottawa Hospital Research Institute

Effects of Non-Glucose-Based Peritoneal Dialysis Solution "EXTRANEAL" on Changes in Leptin Levels and Sympathetic Activity Induced by Conventional Glucose-Based Dialysate "DIANEAL" in Patients on Peritoneal Dialysis

Hypothesis:

Patients starting peritoneal dialysis with a glucose-based regimen have high sympathetic activity in response to an increase in leptin and insulin. Converting patients from a regimen of only glucose containing dialysate to a regimen with non-glucose-based solution, icodextrin, will reduce the insulin and leptin levels and will reverse dialysis-induced increases in sympathetic activity.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Cardiovascular mortality remains higher among patients treated with peritoneal dialysis as compared to patients treated with hemodialysis. Sympathetic hyperactivity is considered a significant emerging risk factor for cardiovascular mortality among patients with ESRD (End-Stage Renal Disease). Sympathetic activity, via its hemodynamic effects and trophic effects, and in interaction with RAAS (Renin Angiotensin Aldosterone System), does play a major role in cardiac and vascular remodelling, development of LVH and vascular hypertrophy, as well as progression to CHF. Glucose-based dialysate induces hyperinsulinemia and hyperleptinemia. We propose that hyperleptinemia induced by glucose-based peritoneal solution is a significant contributing factor to sympathetic hyperactivity in ESRD patients treated with PD, and could be prevented by non-glucose-based PD solution such as icodextrin-based.

Adult patients with ESRD starting PD as their first renal replacement therapy modality will be studied. Patients will be recruited 1-3 weeks prior to starting PD treatment. At baseline, specific studies for microneurography (MSNA), fasting plasma insulin, leptin, catecholamines and brain natriuretic peptide (BNP) will be performed. EKG will be recorded and digitized for further assessment of heart rate variability using power spectral analysis. Extracellular fluid volume status will be assessed by bioelectrical impedance. Central vascular volume will be assessed from inferior vena cava (IVC) by heart ultrasound. Consequently 24-h ambulatory blood pressure monitoring(ABPM)and a 24-h urine collection for urea clearance and creatinine clearance will be done.

All participants into the study will receive a PD treatment for 6 weeks with standard glucose-based PD solution Dianeal. The specific studies are repeated at 6 weeks.Then, patients will be randomized to one of the two groups (arms). One group will continue with Dianeal PD solution for another 12 weeks. The other group will receive Dianeal during the day and Extraneal, icodextrin or non-glucose based solution, during the night only, for the next 12 weeks. The specific studies are repeated at 12 weeks after randomization (18 weeks of PD treatment).

Studietype

Intervensjonell

Registrering (Faktiske)

50

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
        • Ottawa Hospital Research Institute

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Adult (age 18 years and older)
  • Patients with end-stage renal disease(ESRD)/chronic kidney disease(CKD)stage 5

Exclusion Criteria:

  • Diabetes Mellitus
  • Acute coronary syndrome in the past 6 months
  • Cardiac arrhythmias (2nd and 3rd degree heart block or premature ventricular complexes in Lown classes 4 or 5)
  • Symptoms suggestive of obstructive or central sleep apnea (with a score of > 10 on Epworth sleepiness scale)
  • Patients taking Clonidine
  • Body mass index (BMI) > 34
  • Patients unable to give consent
  • Pregnant women
  • Patients with leg injury involving nerve damage
  • Patients taking anticoagulant medication
  • Patients with significant bleeding disorder or liver disorder
  • Hemoglobin <1.05 g/dl at the time of initiation of therapy
  • patients with unilateral or bilateral nephrectomy
  • Planned kidney transplant in the next 4 months
  • Life expectancy under 6 months
  • Oliguria (urine output less than 400 ml per day)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: DIANEAL
One group of patients will start peritoneal dialysis with the glucose-based solution (DIANEAL) for 6 weeks, then will continue with the same type of solution for another 12 weeks.
Annen: DIANEAL

Weeks 1 to 6 (6 weeks):

  • CAPD (Continuous Ambulatory Peritoneal Dialysis)patients will receive three 4-6 hour dwells of DIANEAL during the day and one 8-10-hour dwell of DIANEAL during the night
  • CCPD (Continuous Cycler Peritoneal Dialysis)patients will receive one-two 4-6 hour dwells of DIANEAL during the day and three to seven 2-4-hour dwells of DIANEAL during the night

Weeks 7 to 18 (12 weeks):

*same regimen as weeks 1 to 6, for both CAPD and CCPD patients

Andre navn:
  • Dextrose-based PD solution
Aktiv komparator: EXTRANEAL
The other group of patients will start peritoneal dialysis with the glucose-based solution (DIANEAL) for 6 weeks, then will continue with DIANEAL solution during the day and the non-glucose-based solution, EXTRANEAL, during the night
Annen: EXTRANEAL

Weeks 1 to 6 (6 weeks):

  • CAPD (Continuous Ambulatory Peritoneal Dialysis)patients will receive three 4-6 hour dwells of DIANEAL during the day and one 8-10-hour dwell of DIANEAL during the night
  • CCPD (Continuous Cycler Peritoneal Dialysis)patients will receive one-two 8-12-hour dwells of DIANEAL during the day and three to seven 2-4-hour dwells of DIANEAL during the night

Weeks 7 to 18 (12 weeks):

  • CAPD (Continuous Ambulatory Peritoneal Dialysis)patients will receive three 4-6 hour dwells of DIANEAL during the day and one 8-10-hour dwell of EXTRANEAL during the night
  • CCPD (Continuous Cycler Peritoneal Dialysis)patients will receive one-two 8-12-hour dwells of DIANEAL during the day and one 8-12-hour dwell of EXTRANEAL during the night
Andre navn:
  • Icodextrin-based PD solution

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in muscle sympathetic nerve activity(MSNA)
Tidsramme: 6 weeks on PD and 18 weeks on PD

Muscle sympathetic nerve activity(MSNA) is measured by microneurography at

  • baseline (before starting peritoneal dialysis)
  • 6 weeks of PD
  • 18 weeks of PD(12 weeks after randomization)

MSNA increases on a glucose-based dialysis regimen and may decrease by adding non-glucose-based solution
6 weeks on PD and 18 weeks on PD
Changes in leptin levels
Tidsramme: 6 weeks on PD and 18 weeks on PD
Plasma leptin increases on a glucose-based peritoneal dialysis regimen and may decrease by adding non-glucose-based solution to the dialysis regimen
6 weeks on PD and 18 weeks on PD

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in blood pressure as assessed from 24-hour ambulatory blood pressure monitor (ABPM)
Tidsramme: 6 weeks on PD and 18 weeks on PD
Blood pressure will be assessed with 24-hour ABPM at baseline, 6 weeks on PD and 18 weeks after starting peritoneal dilaysis. Summary measures of each day and night period include average systolic and diastolic BP as well as % nocturnal dipping. These summary measures can predict cardiovascular events more accurately than casual BP measures
6 weeks on PD and 18 weeks on PD
Changes in extracellular volume assessed by bioelectrical impedance (BIA)
Tidsramme: 6 weeks on PD and 18 weeks on PD
Bioelectrical impedance directly measures extracellular fluid volume and total body water. The test is based on the ability to detect differences in the conductive properties of a cell by measuring its resistance (impedance) to electrical current. The technique is reliable for tracking sequential changes in extracellular fluid volume.
6 weeks on PD and 18 weeks on PD
Changes in heart rate variability
Tidsramme: 6 weeks on PD and 18 weeks on PD
During the microneurography testing, EKG is recorded. Heart rate and heart rate variability(HRV) will be analyzed from EKG data at baseline, 6 weeks and 18 weeks after starting dialysis.
6 weeks on PD and 18 weeks on PD
Changes in central intravascular volume assessed by cardiac ultrasound
Tidsramme: 6 weeks on PD and 18 weeks on PD
Central intravascular volume will be assessed by measuring inferior vena cava (IVC) diameter during cardiac ultrasound at baseline, 6 weeks and 18 weeks on dialysis treatment
6 weeks on PD and 18 weeks on PD
Changes in plasma catecholamines levels
Tidsramme: 6 weeks on PD and 18 weeks on PD
*Plasma catecholamines (epinephrine and norepinephrine) increase on a glucose-based peritoneal dialysis regimen and may decrease by adding non-glucose-based solution to the dialysis regimen
6 weeks on PD and 18 weeks on PD
Changes in BNP (Brain Natriuretic Peptide)levels
Tidsramme: 6 weeks on PD and 18 weeks on PD
*Brain Natriuretic Peptide (BNP)increases on a glucose-based peritoneal dialysis regimen and may decrease by adding non-glucose-based solution to the dialysis regimen
6 weeks on PD and 18 weeks on PD
Changes in plasma insulin levels
Tidsramme: 6 weeks on PD and 18 weeks on PD
*Plasma insulin increases on a glucose-based peritoneal dialysis regimen and may decrease by adding non-glucose-based solution to the dialysis regimen
6 weeks on PD and 18 weeks on PD

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ottawa Hospital Research Institute

Samarbeidspartnere

Heart and Stroke Foundation of Ontario

Etterforskere

  • Hovedetterforsker: Marcel Ruzicka, MD, PHD, Ottawa Hospital Research Institute

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 (Faktiske)

1. juli 2007

Primær fullføring (Faktiske)

1. desember 2018

Studiet fullført (Faktiske)

1. desember 2018

Datoer for studieregistrering

Først innsendt

13. oktober 2010

Først innsendt som oppfylte QC-kriteriene

22. oktober 2010

Først lagt ut (Anslag)

26. oktober 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NA6951

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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