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

NCT01228279 | Completed Phase 4 DMC

• 1 other identifier: NA6951
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End-stage Renal Disease (ESRD); Kidney Disease

Keywords

Peritoneal Dialysis; Dialysis Solutions; Artificial Kidney; Renal Replacement Therapy; Renal Dialysis; Sympathetic Nervous System; Leptin; Icodextrin

Outcome Measures

Primary Outcomes (2)

• Changes in muscle sympathetic nerve activity(MSNA)

  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

  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

Secondary Outcomes (7)

• Changes in blood pressure as assessed from 24-hour ambulatory blood pressure monitor (ABPM)

  6 weeks on PD and 18 weeks on PD

• Changes in extracellular volume assessed by bioelectrical impedance (BIA)

  6 weeks on PD and 18 weeks on PD

• Changes in heart rate variability

  6 weeks on PD and 18 weeks on PD

• Changes in central intravascular volume assessed by cardiac ultrasound

  6 weeks on PD and 18 weeks on PD

• Changes in plasma catecholamines levels

  6 weeks on PD and 18 weeks on PD

Study Arms (2)

DIANEAL

ACTIVE COMPARATOR

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.

Other: DIANEAL

EXTRANEAL

ACTIVE COMPARATOR

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

Other: EXTRANEAL

Interventions

DIANEAL OTHER

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

Also known as: Dextrose-based PD solution

DIANEAL

EXTRANEAL OTHER

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

Also known as: Icodextrin-based PD solution

EXTRANEAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Kidney Diseases

Interventions

Icodextrin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Study Officials

• Marcel Ruzicka, MD, PhD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Marcel Ruzicka

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: October 26, 2010
• Study Start: July 1, 2007
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 15, 2021

Record last verified: 2021-03

Locations

CA (1)