Clinical trial NCT00906555: The Effect of Different Dosages of Solute Clearance on Outcome in Twice Weekly Hemodialysis Patients
Official title: The Effect of Different Dosages of Solute Clearance on Outcome in Twice Weekly Hemodialysis Patients-A Prospective, Randomized, Multi-center Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Replacement Therapy
Hemodialysis
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: clinical outcome including mortality and morbidity
timeFrame: 2 years
Secondary outcomes:
measure: complications including cardiovascular disease, nutritional and inflammation status, calcium and phosphorus level, anemia and life quality
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University school of medicine
Study officials:
affiliation: RenJi Hospital
name: Jiaqi Qian, MD
role: PRINCIPAL_INVESTIGATOR
References: