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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00906555
First Posted: May 21, 2009
Last Update Posted: October 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aiwu Lin, Shanghai Jiao Tong University School of Medicine
May 20, 2009
May 21, 2009
October 13, 2016
June 2009
June 2012   (Final data collection date for primary outcome measure)
clinical outcome including mortality and morbidity [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT00906555 on ClinicalTrials.gov Archive Site
complications including cardiovascular disease, nutritional and inflammation status, calcium and phosphorus level, anemia and life quality [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
 
The Effect of Different Dosages of Solute Clearance on Outcome in Twice Weekly Hemodialysis Patients
The Effect of Different Dosages of Solute Clearance on Outcome in Twice Weekly Hemodialysis Patients-A Prospective, Randomized, Multi-center Intervention Study
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Renal Replacement Therapy
  • Hemodialysis
Procedure: modification of hemodialysis parameters on dialysis machine
Modification of hemodialysis parameters such as dialysis time, blood flow rate and dialysate flow rate to reach a Kt/V ≥ 1.7.
  • No Intervention: 1
    hemodialysis patients with baseline Kt/V between 1.2 and 1.7 (1.2 ≤ Kt/V < 1.7)
  • Experimental: 2
    Modification of hemodialysis parameters such as dialysis time, blood flow rate and dialysate flow rate to reach a Kt/V ≥ 1.7.
    Intervention: Procedure: modification of hemodialysis parameters on dialysis machine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
June 2012
June 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients undergoing maintenance hemodialysis for more than 12 weeks were included in the study.
  2. 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).
  3. Age from 18 to 80, male or female.
  4. Patients have long term vascular access.

Exclusion Criteria:

  1. Patients with an expected survival less than 12 months.
  2. Without informed consent.
  3. Unstable organ disease such as uncurable cancer,active inflammation disease and mental disease.
  4. Patients with an expected follow up less than 48 weeks,such as planned kidney transplant.
  5. 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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00906555
08dz1900501-a
Yes
Not Provided
Plan to Share IPD: No
Aiwu Lin, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
Not Provided
Principal Investigator: Jiaqi Qian, MD Renji Hospital, Shanghai Jiao Tong University school of medicine
Shanghai Jiao Tong University School of Medicine
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP