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NCT Number: NCT00906555

The Effect of Different Dosages of Solute Clearance on Outcome in Twice Weekly Hemodialysis Patients

Adequacy of solute clearance makes a profound impact on clinical outcome in maintenance hemodialysis patients. Thus far, guidelines on the target of solute clearance (Kt/V or URR) are based on patients with three dialysis sessions per week. However, quite a few patients have their dialysis sessions twice per week in China. The dialysis target of solute clearance in this population remains to be elucidated. The aim of this study was to explore the optimum target solute clearance (Kt/V or URR) in maintenance hemodialysis patients with two dialysis sessions per week. Two groups of hemodialysis patients with different Kt/V (1.2 ≤ Kt/V < 1.7 versus Kt/V ≥ 1.7) will be followed until 96 weeks in this prospective, randomized, multi-center, interventional study.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Renji Hospital, Shanghai Jiao Tong University school of medicine

Shanghai, 200001, China

About this study

This is a prospective, randomized, multi-center intervention study. 400 maintenance hemodialysis patients with twice dialysis sessions per week will be enrolled into the study. All the patients have their baseline Kt/V between 1.2 and 1.7 (1.2 ≤ Kt/V < 1.7). After treatment intervention, the patients will be randomized to two groups according to their different Kt/V (1.2 ≤ Kt/V < 1.7 vs. Kt/V ≥ 1.7), then the patients will be regularly followed up at baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks and 96 weeks. Clinical outcomes such as mortality, complications and life quality between the two groups will be investigated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing maintenance hemodialysis for more than 12 weeks were included in the study.
  • The patients have their dialysis sessions twice weekly and have baseline Kt/V between 1.2 and 1.7 (1.2 ≤ Kt/V < 1.7).
  • Age from 18 to 80, male or female.
  • Patients have long term vascular access.

Exclusion criteria

  • Patients with an expected survival less than 12 months.
  • Without informed consent.
  • Unstable organ disease such as uncurable cancer,active inflammation disease and mental disease.
  • Patients with an expected follow up less than 48 weeks,such as planned kidney transplant.
  • Other conditions regarded as unsuitability by investigator, such as pregnancy, alcohol or drug indulgence. A dry weight more than 90 kg is also excluded in the study.

Treatment and study plan

modification of hemodialysis parameters on dialysis machine

Procedure

Modification of hemodialysis parameters such as dialysis time, blood flow rate and dialysate flow rate to reach a Kt/V ≥ 1.7.

Primary outcomes

  1. clinical outcome including mortality and morbidity

    Time frame: 2 years

Secondary outcomes

  1. complications including cardiovascular disease, nutritional and inflammation status, calcium and phosphorus level, anemia and life quality

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

The Effect of Different Dosages of Solute Clearance on Outcome in Twice Weekly Hemodialysis Patients-A Prospective, Randomized, Multi-center Intervention Study

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 21, 2009
Registry last updated
Oct 13, 2016

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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