In-Centre Nocturnal Hemodialysis (INHD): A Long-Term Follow-Up Study

NCT02684773 | Completed

• 1 other identifier: G-14-0005856
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 2

Brief Summary

Background: In 2010, approximately 39000 Canadians had end-stage renal disease (ESRD), and the prevalence rate of dialysis has increased by 189% over the past 2 decades. The annual mortality rate remains high at \~15%, and cardiovascular events are the leading cause of death. Intensification of conventional dialysis schedules has been the major focus in recent years. Currently, most Canadian dialysis patients receive conventional in-center hemodialysis (CHD), which is administered as a 3-4 hour session 3/week. Recent research has focused on home nocturnal hemodialysis (8 hours of hemodialysis at home for 5-6 nights/week), which may have substantial cardiovascular benefits, including regression of left ventricular (LV) hypertrophy, improved LV ejection fraction and enhanced blood pressure control. Nevertheless, this dialysis modality is only feasible in a highly selected minority of ESRD patients who can self-manage their dialysis treatment at home. In-center nocturnal hemodialysis (INHD), administered as 7-8 hours of hemodialysis in hospital for 3nights/week, represents a promising and practical alternative for many dialysis patients. In a Canadian Institutes for Health Research (CIHR) supported cohort study, the investigators have recruited 67 patients and have completed 1-year follow-up. There is a compelling need for longer-term follow-up, since all the published randomized controlled trials are of short duration (6-12 months), while renal replacement therapy is a life-long treatment. Furthermore, the observed large variability of cardiac remodeling in individual ESRD patients remains poorly understood. Therefore, the current study is an extended follow-up phase (5 years from enrollment) on the completed 1-year follow-up period and the purpose of this study is to objectively evaluate the long-term effects of more intensified hemodialysis treatment which the INHD modality offers. Need for Long-term and Generalizable Data: In contrast to the seminal Alberta trial which showed a significant LV mass reduction with home nocturnal hemodialysis, the recently reported Frequent Hemodialysis Network Nocturnal Trial demonstrated only a trend toward reduction in LV mass. It is likely that the highly selected participants, inadequate trial power and duration (12 months) account for the observed results. Currently, it is unknown whether INHD, which is less intensive but more feasible for most ESRD patients, is associated with similar cardiovascular benefits in the long term. Objective:

1. 1.To determine the long-term effects of INHD on (i) LV mass; (ii) global and regional LV systolic and diastolic function; (iii) myocardial tissue characteristics; (iv) left atrial structure and function; (v) selected cardiovascular biomarkers in ESRD patients.
2. 2.To examine the determinants and mechanisms of cardiac remodeling in ESRD

Conditions

End-stage Renal Disease; Left Ventricular Hypertrophy

Keywords

Hemodialysis; Left Ventricular Mass; Cardiac Magnetic resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular mass index by cardiac MRI assessment

  5 years from Baseline procedure

Secondary Outcomes (8)

• Changes in left ventricular end diastolic and systolic volume by cardiac MRI assessment

  5 years from baseline procedure

• Changes in regional left ventricular systolic and diastolic function by cardiac MRI assessment

  5 years from baseline procedure

• Changes in myocardial tissue characteristics by cardiac MRI assessment

  5 years from baseline procedure

• Changes in blood pressure

  5 years from baseline procedure

• Changes in quality of life

  5 years from baseline procedure

Study Arms (2)

Incentre Nocturnal Hemodialysis

These are patients who converted to incentre nocturnal hemodialysis (8 hours/session, 3 sessions/week) from conventional hemodialysis (4 hours/session, 3 sessions/week) at the inception of this study and are eligible for the long-term follow-up phase of the study.

Procedure: In-centre Nocturnal Hemodialysis

Conventional Hemodialysis

These are patients treated with conventional hemodialysis (4 hours/session, 3 session/week) who elected to remain on this dialysis schedule at the inception of this study and are eligible for the long term follow-up phase of the study.

Procedure: Conventional Hemodialysis

Interventions

Conventional Hemodialysis PROCEDURE

The intervention involves 3 hemodialysis sessions/week that consists of 4 hours/session

Conventional Hemodialysis

In-centre Nocturnal Hemodialysis PROCEDURE

The intervention involves 3 hemodialysis sessions/week administered overnight (8 hours/session) in-hospital

Incentre Nocturnal Hemodialysis

Eligibility Criteria

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

Study Population

The patients who converted to in-centre nocturnal hemodialysis and their matched controls will be drawn from a population of prevalent chronic hemodialysis patients.

You may qualify if:

• all patients who were enrolled in the original one-year follow-up phase of the study and are eligible for the long-term follow-up phase

You may not qualify if:

• inability to provide informed consent for long-term follow-up

Sponsors & Collaborators

• Unity Health Toronto: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (2)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and Plasma sample collection

MeSH Terms

Conditions

Kidney Failure, Chronic; Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; 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; Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical

Study Officials

• Ron Wald, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Andrew T Yan, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: February 18, 2016
• Study Start: July 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)