Effect of Different Dialysis Dosage on Prognosis in Maintenance Peritoneal Dialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00912821
First received: June 1, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

Peritoneal dialysis (PD) is an important model of renal replacement therapy for end-stage renal disease (ESRD) patients. Thus far, evidence for the initiation dosage of PD treatment is lacking, most patients begin their PD with four 2 L exchanges per day. However, many patients have their residual renal function at the initiation of PD, an 8 L dialysate per day will enhance the toxicity of bioincompatible dialysate and increase the economic burden compared with that of 6 L dialysate per day. Thus, the investigators perform a prospective, randomized, controlled, multi-center clinical study. The patients initiation of PD treatment within 6 months are randomized to be assigned to two groups: 6 L of dialysate per day and 8 L of dialysate per day, follow up will be regularly performed until 96 weeks. Clinical outcomes such as mortality, complications and life quality between the two groups will be investigated.


Condition Intervention Phase
End-Stage Renal Disease
Drug: 6 L dialysate
Drug: 8 L dialysate
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: Effect of Different Dialysis Dosage on Prognosis in Maintenance Peritoneal Dialysis Patients - A Prospective, Randomized, Controlled, Multi-Center Clinical Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • clinical outcome including mortality and technical failure [ 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: 200
Study Start Date: March 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 8 L dialysate
8 L peritoneal dialysis solution
Drug: 8 L dialysate
8 L peritoneal dialysis solution
Experimental: 6 L dialysate
6 L peritoneal dialysis solution
Drug: 6 L dialysate
6 L peritoneal dialysis solution

Detailed Description:

To investigate the effect, feasibility and safety of 6L of dialysate per day after initiation of peritoneal dialysis (PD), we perform a prospective, randomized, controlled, multi-center clinical study. The patients initiation of PD treatment within 6 months are randomized to be assigned to two groups: 6L of dialysate per day and 8L of dialysate per day, follow up will be regularly performed at baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks and 96 weeks. Serum biochemical parameters, Kt/V, residual renal function (RRF), life quality and cardiovascular test will be regularly recorded. Clinical outcomes such as mortality, technique failure, 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. Age from 18 to 80, male or female.
  2. End stage renal disease patients (eGFR < 15 ml/min/1.73 m2).
  3. Maintenance peritoneal dialysis within 6 months after initiation of PD.
  4. With informed consent.

Exclusion Criteria:

  1. Acute renal injury.
  2. Patients with an expected follow up less than 6 months sch as renal transplantation.
  3. Transferred from hemodialysis or renal transplantation.
  4. Residual renal function eGFR less than 1 ml/min.
  5. HIV positive.
  6. Cancer patients.
  7. Unstable organ disease such as active tuberculosis and severe hepatitis. Patients with an expected follow up less than 48 weeks, such as planned kidney transplant.
  8. Other conditions regarded as unsuitability by investigator, such as pregnancy, severe malnutrition and recent peritonitis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912821

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

Locations
China
Renji Hospital, Shanghai Jiao Tong University school of medicine Recruiting
Shanghai, China, 200001
Contact: Jiaqi Qian, MD    86-21-53882163    jiaqiqian@126.com   
Principal Investigator: Jiaqi Qian, MD         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided

Responsible Party: Jiaqi Qian/professor, Renji Hospital, Shanghai Jiao Tong University school of medicine
ClinicalTrials.gov Identifier: NCT00912821     History of Changes
Other Study ID Numbers: 08dz1900501-b
Study First Received: June 1, 2009
Last Updated: June 1, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Renal Replacement Therapy
Peritoneal dialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on April 23, 2014