A Clinical Trial of IntensiVE Dialysis

Study Overview
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Brief Summary
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This study will assess clinical outcomes of extended weekly hours of haemodialysis (>= 24 hours per week) compared with standard hours of haemodialysis (<=18 hours/week) in people with ESKD.

Detailed Description
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A rapidly increasing volume of observational data suggests substantial benefits may be associated with an increased duration of dialysis. As well as improved quality of life, improved functioning and beneficial changes in a variety of laboratory parameters, it has been suggested that extended dialysis sessions might reduce mortality and major morbidity. Uncontrolled data from centres that have been providing extended dialysis shows dramatically lower mortality rates compared to those observed in centres providing standard duration dialysis. Recent analyses of extended dialysis conclude that the savings achieved in drug and hospitalization costs may lead to an overall reduction in costs compared with traditional forms of dialysis. In this trial, we propose to examine the effects of extended dialysis (24 hours weekly or more) compared to standard dialysis (18 hours or less weekly) in patients with ESKD. The proposed study is a multi-centre, open label, randomised, controlled trial. The study began with a pilot phase which was converted to the current main study on the receipt of peer-reviewed funding for the full study.

Official Title
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ACTIVE Dialysis - A Multicentre, Unblinded, Randomised, Controlled Trial to Assess Quality of Life, Clinical Outcomes and Cost Utility for Extended vs Standard Duration of Dialysis in Patients With End Stage Kidney Disease.

Conditions
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Renal Replacement Therapy, Renal Dialysis, End Stage Kidney Disease, End Stage Renal Disease, Uremia

Intervention / Treatment
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* Procedure: haemodialysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Incident or prevalent patients requiring maintenance haemodialysis therapy for ESKD Aged 18 years or older Undergoing dialysis for 18 hours per week or less Suitable for either extended or standard dialysis in the view of the treating physician Agreeable to randomisation Exclusion Criteria: Life expectancy of less than 6 months Definite plans to undergo renal transplantation within 12 months of entry to the study Inability to complete quality of life questionnaire Concomitant major illness that would limit assessments and followup High chance that the patient will not adhere to study treatment and follow up in the view of the treating physician.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: extended hours<br>24 or more hours per week of hemodialysis | Procedure: haemodialysis<br>* Comparison of different weekly duration of haemodialysis treatment<br>* Other names: Renal replacement therapy;|
| Active Comparator: standard hours<br>18 or less hours per week of hemodialysis | Procedure: haemodialysis<br>* Comparison of different weekly duration of haemodialysis treatment<br>* Other names: Renal replacement therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end-point for this study is the difference in the change in quality of life between the two groups from randomisation to the 12 month follow-up as measured by the EQ-5D instrument. |  | 12 months from randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival and cardiovascular analyses |  | 12 months | 
| Quality of life and patient acceptability |  | 12 months | 
| Safety outcomes |  | 12 months | 
| Costs associated with each intervention |  | 12 months | 
| Changes in biochemical and haematological parameters |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trial, Clinical Trial, Controlled Clinical Trial, Clinical Trial, Phase IV, Multicenter Study, End Stage Kidney Disease, Hemodialysis, Renal Dialysis, Renal Replacement Therapy, Nocturnal Dialysis, Extended dialysis, Quality of Life, Quality Adjusted Life Year, Hypertrophy, Left Ventricular, Blood Pressure, Hypertension, Anemia, Hematinics, Erythropoiesis Stimulating Agents, Cost-utility Analysis, Economic Evaluation, Health Care Utilisation, Health Care Costs, Health Expenditures, Hospitalization, Cost Analysis, Cardiovascular Diseases, Acute Coronary Syndrome, Myocardial Infarction, Stroke, Cerebrovascular Disorders, Mortality, Arteriovenous Fistula, Arteriovenous Shunt, Surgical, Thrombosis, Infection