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NCT Number: NCT02525497

Safety, Effectiveness and Manipulability Evaluation of a Domestic PD Machine

This study is a randomized, multi-center，crossover study of a domestic FM peritoneal dialysis machine and Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a domestic peritoneal dialysis machine.

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Key information

Conditions

Kidney Failure,Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

About this study

Our study is a randomized, multi-center，crossover study. It compares a domestic FM peritoneal dialysis machine with Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a domestic peritoneal dialysis machine.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age ≥18, male or female Dialysis duration:≥30 days Sign the written informed consent

Exclusion criteria

Hemodialysis Exit site infection or tunnel infection Peritonitis ≤30 days before screening Catheter mechanical failure Anti-HIV positive Allergic to components of dialysate Comorbidity:Active, residual malignant tumor, or systemic infection, liver cirrhosis, severe congestive heart failure,hypertension 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

Treatment and study plan

FM peritoneal dialysis machine

Device

FM peritoneal dialysis machine APD 10L/10h

HOMECHOICE peritoneal dialysis machine

Device

HOMECHOICE peritoneal dialysis machine APD 10L/10h

Primary outcomes

  1. Daily peritoneal Kt/V

    Time frame: 1 day

Secondary outcomes

  1. The accuracy of filling

    Time frame: 1 day

Other outcomes

  1. The accuracy of filling temperature

    Time frame: 1 day

  2. Serum sodium before and after dialysis

    Time frame: 1 day

  3. Serum potassium before and after dialysis

    Time frame: 1 day

  4. Serum calcium before and after dialysis

    Time frame: 1 day

  5. Serum phosphorus before and after dialysis

    Time frame: 1 day

  6. Serum carbon dioxide binding force before and after dialysis

    Time frame: 1 day

  7. Serum creatinine before and after dialysis

    Time frame: 1 day

  8. Serum urea nitrogen before and after dialysis

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

A Randomized, Multicenter, Crossover Study Comparing the Domestic FM Peritoneal Dialysis Machine With Baxter HOMECHOICE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 17, 2015
Registry last updated
Dec 11, 2019

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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