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NCT Number: NCT00912821

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 18 to 80, male or female.
  • End stage renal disease patients (eGFR < 15 ml/min/1.73 m2).
  • Maintenance peritoneal dialysis within 6 months after initiation of PD.
  • With informed consent.

Exclusion criteria

  • Acute renal injury.
  • Patients with an expected follow up less than 6 months sch as renal transplantation.
  • Transferred from hemodialysis or renal transplantation.
  • Residual renal function eGFR less than 1 ml/min.
  • HIV positive.
  • Cancer patients.
  • 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.
  • Other conditions regarded as unsuitability by investigator, such as pregnancy, severe malnutrition and recent peritonitis.

Treatment and study plan

6 L dialysate

Drug

6 L peritoneal dialysis solution

8 L dialysate

Drug

8 L peritoneal dialysis solution

Primary outcomes

  1. clinical outcome including mortality and technical failure

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Effect of Different Dialysis Dosage on Prognosis in Maintenance Peritoneal Dialysis Patients - A Prospective, Randomized, Controlled, Multi-center Clinical Study

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jun 3, 2009
Registry last updated
Oct 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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