Safety and Effectiveness Evaluation of Two Kinds of Peritoneal Dialysate

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the effectiveness and safety of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate, investigate the proper dialysis dose for Chinese CAPD patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese PLA General Hospital
• Treatments: Dialysis Solutions

Criteria

Inclusion Criteria:

• Age ≥18, male or female

• Patients with end stage renal diseases

• Dialysis mode: CAPD

• Dialysis duration:≥30 days and ≤6 months

• Be capable of implementing home dialysis

• Diabetic nephropathy, 3ml/min≤ residual renal GFR ≤15ml/min; other renal diseases, 3ml/min≤ residual renal GFR ≤10ml/min

• Sign the written informed consent

Exclusion Criteria:

• Acute renal failure

• Planing to receive kidney transplantation in 2 years

• Hemodialysis

• Exit site infection or tunnel infection

• Presenting 2/3 of the following: a. abdominal pain, turbid ascites, with or without fever; b. drainage fluid WBC>100×106/L, neutrophil ratio>50%; c.culture positive/ Gram stain positive in drainage fluid;

• Anti-HIV positive

• Allergic to components of dialysate

• Active, residual malignant tumor, or systemic infection, liver cirrhosis, severe congestive heart failure, anemia（Hb<80g/L）,malnutrition（Serum Alb<28g/L）,refractory hypertension

• Identified peritoneal high transportation by peritoneal equilibration test (PET)

• Extreme body shape (height> 185cm or height <145cm), obesity (BMI ≥ 33kg/m2)

• Poor compliance

• Pregnant or lactating, women of childbearing age do not agree to use effective contraceptive measures during the trial

• Has a history of alcoholism and drug abuse (defined as illegal drugs)

• Any circumstances when patients are believed unsuitable for this trial