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Completed

NCT Number: NCT00004285

Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis

OBJECTIVES: I. Evaluate whether hemodialysis providing a 2-pool, variable volume urea kinetic modelling value of 1.05 versus 1.45 reduces mortality and morbidity in patients with end stage renal disease.

II. Compare the efficacy of high versus low flux dialyzer membranes.

Completed

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester School of Medicine

Rochester, New York, 14642, United States

About this study

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, age, and diabetes prior to dialysis initiation.

Patients are randomly assigned to 1 of 4 groups: moderate dose dialysis, low flux membrane; high dose dialysis, low flux membrane; moderate dose dialysis, high flux membrane; or high dose dialysis, high flux membrane. Moderate dose is a target eKt/V of 1.05 and high dose is 1.45. The dose and delivery of dialysis are measured monthly by the equilibrated fractional clearance of urea (eKt/V) calculated with double pool kinetics.

Patients are dialyzed 3 times a week in the shortest possible time (minimum 2.5 hours), adjusted for adequate fluid removal. General medical care, protein and calorie intake, and dialyzer reuse and other aspects of dialysis therapy are standardized. The protocol document lists approved dialyzers; no unsubstituted cellulosic membranes are permitted.

The intervention phase of this study is 5 years. Patients are followed for survival.

Who can participate

Healthy volunteers accepted: No

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

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • End stage renal disease that requires in-center hemodialysis 3 times/week On hemodialysis for at least 3 months (6 months following renal transplant)
  • No scheduled renal transplant from living donor

--Prior/Concurrent Therapy--

  • No concurrent intervention studies unless ancillary to this protocol No concurrent investigational drugs

--Patient Characteristics--

  • Hepatic: Albumin at least 2.6 g/dL by nephelometry No cirrhosis with encephalopathy or abnormal PT
  • Renal: Urea clearance (interdialytic) no greater than 1.5 mL/min per 35 liters total urea volume
  • Cardiovascular: No New York Heart Association class IV congestive heart failure despite maximal therapy No unstable angina No new onset angina No recent exacerbation of frequency, duration, or severity of angina
  • Pulmonary: No chronic pulmonary disease requiring supplemental oxygen
  • Other: Not hospitalized in acute or long term care facility at entry No active malignancy requiring chemotherapy or radiotherapy No AIDS No active systemic infection, e.g., tuberculosis or fungal infection No mental incompetence or other contraindication to protocol therapy Not pregnant Geographically available for treatment at participating institution No more than 20 missed treatments/year

Treatment and study plan

Standard dose, low flux hemodialysis

Device

Standard dose, high flux hemodialysis

Device

High dose, low flux hemodialysis

Device

High dose, high flux hemodialysis

Device

Primary outcomes

  1. Death from any cause

    Time frame: 5 years

Secondary outcomes

  1. First hospitalization for cardiac causes or death from any cause

    Time frame: 5 years

  2. First hospitalization for infection or death from any cause

    Time frame: 5 years

  3. First >15% decrease in albumin or death from any cause

    Time frame: 5 years

  4. All hospitalizations not related to vascular access

    Time frame: 5 years

  5. Death due to cardiac causes

    Time frame: 5 years

  6. First hospitalization or death due to cardiac causes

    Time frame: 5 years

  7. Death due to infection

    Time frame: 5 years

  8. First hospitalization or death due to infection

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Collaborators

  • Brigham and Women's Hospital
  • Duke University
  • Emory University
  • Icahn School of Medicine at Mount Sinai
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • Main Line Health
  • The Cleveland Clinic
  • Tufts Medical Center
  • University of Alabama at Birmingham
  • University of California, Davis
  • University of Illinois at Chicago
  • University of Rochester
  • University of Texas Southwestern Medical Center
  • University of Utah
  • Vanderbilt University
  • Wake Forest University Health Sciences
  • Washington University School of Medicine

Registry information

Official study title

Randomized Study of Standard vs High Amount of Hemodialysis Using Low vs High Flux Dialyzer Membranes for End Stage Renal Disease

Acronym: HEMO

Important dates

Study start
1995
Primary completion
2001
Study completion
2001
First posted
Oct 19, 1999
Registry last updated
Sep 14, 2017

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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