Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01228279
Other study ID # NA6951
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 2007
Est. completion date December 2018

Study information

Verified date March 2021
Source Ottawa Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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).


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Other:
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
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

Locations

Country Name City State
Canada Ottawa Hospital Research Institute Ottawa Ontario

Sponsors (2)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Changes in blood pressure as assessed from 24-hour ambulatory blood pressure monitor (ABPM) 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
Secondary Changes in extracellular volume assessed by bioelectrical impedance (BIA) 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
Secondary Changes in heart rate variability 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
Secondary Changes in central intravascular volume assessed by cardiac ultrasound 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
Secondary Changes in plasma catecholamines levels *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
Secondary Changes in BNP (Brain Natriuretic Peptide)levels *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
Secondary Changes in plasma insulin levels *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
See also
  Status Clinical Trial Phase
Completed NCT02369354 - Transplant Social Worker Support for Live Kidney Donation in African Americans N/A
Not yet recruiting NCT02225782 - Trial to Compare 1.0 Versus 2.0 mg Alteplase (tPA) Dosing in Restoring Hemodialysis Catheter Function Phase 4
Completed NCT00499187 - Fanconi Syndrome Due to ARVs in HIV-Infected Persons Phase 4
Withdrawn NCT00585429 - Evaluation of Kidney Disease in Liver Transplant Recipients N/A
Completed NCT00379899 - ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis Phase 4
Completed NCT00183248 - Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients Phase 1/Phase 2
Completed NCT00001835 - Oxaliplatin in Cancer Patients With Impaired Kidney Function Phase 1
Completed NCT01331941 - A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function Phase 1
Terminated NCT00436748 - Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease Phase 3
Completed NCT01467466 - Prevention of Serious Adverse Events Following Angiography Phase 3
Completed NCT01235936 - Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia Phase 2
Completed NCT01974999 - A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study
Completed NCT01947829 - Interdialytic Kt/V Variability Measurement With Adimea (IVP STUDY) N/A
Recruiting NCT01240564 - The Nephrotic Syndrome Study Network (NEPTUNE) N/A
Active, not recruiting NCT01228903 - Uric Acid and the Endothelium is CKD N/A
Completed NCT00734357 - Comparative Investigation of Intravenously Administered Omnipaque and Isovue: Effects on Serum Creatinine Concentration in Outpatients N/A
Completed NCT00781417 - Prevention of Secondary Hyperparathyroidism With Vitamin D in Stage II/III Chronic Kidney Disease N/A
Completed NCT00185159 - Olmesartan Medoxomil in Diabetes Mellitus Phase 3
Completed NCT00094484 - Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis Phase 3
Completed NCT00096915 - Study Evaluating Darbepoetin Alfa in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis Phase 3