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

NCT00906555 | Completed Phase 4 DMC

• 1 other identifier: 08dz1900501-a
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Replacement Therapy; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• clinical outcome including mortality and morbidity

  2 years

Secondary Outcomes (1)

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

  2 years

Study Arms (2)

1

NO INTERVENTION

hemodialysis patients with baseline Kt/V between 1.2 and 1.7 (1.2 ≤ Kt/V \< 1.7)

2

EXPERIMENTAL

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

Interventions

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.

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University school of medicine

Shanghai, 200001, China

Location

Study Officials

• Jiaqi Qian, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director, Department of Nephrology, Renji Hospital

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 21, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 13, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)