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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00906555
First received: May 20, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Renal Replacement Therapy
Hemodialysis
 Procedure: modification of hemodialysis parameters on dialysis machine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Different Dosages of Solute Clearance on Outcome in Twice Weekly Hemodialysis Patients-A Prospective, Randomized, Multi-Center Intervention Study

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • clinical outcome including mortality and morbidity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • complications including cardiovascular disease, nutritional and inflammation status, calcium and phosphorus level, anemia and life quality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: June 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906555

Contacts
Contact: Jiaqi Qian, MD 86-21-53882163 jiaqiqian@126.com

Locations
China
Renji Hospital, Shanghai Jiao Tong University school of medicine Not yet recruiting
Shanghai, China, 200001
Contact: Jiaqi Qian, MD     86-21-53882163     jiaqiqian@126.com    
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Jiaqi Qian, MD Renji Hospital, Shanghai Jiao Tong University school of medicine
  More Information

No publications provided

Responsible Party: Jiaqi Qian/professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT00906555     History of Changes
Other Study ID Numbers: 08dz1900501-a
Study First Received: May 20, 2009
Last Updated: May 20, 2009
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on May 22, 2013