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

11 marzo 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

50

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Altro: 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

Altri nomi:
  • Dextrose-based PD solution
Comparatore attivo: 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
Altro: 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
Altri nomi:
  • Icodextrin-based PD solution

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in muscle sympathetic nerve activity(MSNA)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in blood pressure as assessed from 24-hour ambulatory blood pressure monitor (ABPM)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ottawa Hospital Research Institute

Collaboratori

Heart and Stroke Foundation of Ontario

Investigatori

  • Investigatore principale: Marcel Ruzicka, MD, PHD, Ottawa Hospital Research Institute

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 luglio 2007

Completamento primario (Effettivo)

1 dicembre 2018

Completamento dello studio (Effettivo)

1 dicembre 2018

Date di iscrizione allo studio

Primo inviato

13 ottobre 2010

Primo inviato che soddisfa i criteri di controllo qualità

22 ottobre 2010

Primo Inserito (Stima)

26 ottobre 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 marzo 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 marzo 2021

Ultimo verificato

1 marzo 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NA6951

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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