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Completed

NCT Number: NCT00649298

A Clinical Trial of IntensiVE Dialysis

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.

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Key information

Conditions

Renal Replacement Therapy Acute Coronary Syndrome Anemia Arteriovenous Fistula Arteriovenous Malformations Brain Diseases Cardiomegaly Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Embolism and Thrombosis End Stage Kidney Disease End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypertension Hypertrophy Hypertrophy, Left Ventricular Infarction Infections Ischemia Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Dialysis Renal Insufficiency Renal Insufficiency, Chronic Stroke Thrombosis Uremia Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Canberra Hospital, Canberra, Australian Capital Territory, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Haemodialysis

Procedure

Comparison of different weekly duration of haemodialysis treatment

Other names: Dialysis, Renal replacement therapy

Primary outcomes

  1. 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.

    Time frame: 12 months from randomisation

Secondary outcomes

  1. Survival and cardiovascular analyses

    Time frame: 12 months

  2. Quality of life and patient acceptability

    Time frame: 12 months

  3. Safety outcomes

    Time frame: 12 months

  4. Costs associated with each intervention

    Time frame: 12 months

  5. Changes in biochemical and haematological parameters

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

The George Institute

Other

Collaborators

  • Baxter Healthcare Corporation
  • National Health and Medical Research Council, Australia

Registry information

Official study title

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.

Acronym: ACTIVE

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Apr 1, 2008
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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