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Completed

NCT Number: NCT03004963

Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients.

Peritoneal dialysis (PD) is one of established treatments in the end stage renal disease patients. Volume overload is a predictor of mortality in PD patients. In this Randomized controlled trial, the investigators use the Body Composition Monitor (BCM), a multifrequency bioimpedance device, to measure the level of overhydration in PD patients and explore its value in fluid management in peritoneal dialysis patients as well as their prognosis.

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Key information

Conditions

End Stage Renal Disease 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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

About this study

Optimal fluid management is one of the primary objectives of dialysis treatment, and there is significant concern that peritoneal dialysis (PD) patients can become progressively fluid-loaded with time on treatment, especially as residual kidney function declines. Body Composition Monitor (BCM) has the potential to enable better management of fluid balance. The investigators undertake a prospective, randomized, open-label, controlled trial to determine whether availability of longitudinal BCM measures help clinicians maintain stable fluid status over 24 months in 300 peritoneal dialysis patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients 18 years or older but no older than 80 years.
  • who had been on chronic peritoneal dialysis for more than 3 months.
  • All of them have signed the informed consent.

Exclusion criteria

  • were expected to stop PD treatment in 6 months;
  • were amputees;
  • had a cardiac pacemaker or metallic implants;
  • had peritonitis one month before recruitment;
  • treated together with hemodialysis;
  • were during pregnancy or lactation;
  • were positive with HIV;
  • had serious diseases, including cancer, infection and liver cirrhosis, which were not suitable for the study.

Treatment and study plan

Body composition monitor

Device

Both body composition monitor (BCM) is used to evaluate the volume status of patients.

clinical indexes

Device

The investigators evaluate the volume status of patients according to clinical indexes.

Primary outcomes

  1. volume status

    Time frame: 96 weeks

    change in overhydration(OH) value

  2. The incidence of cardiovascular events

    Time frame: 96 weeks

    different incidence of cardiovascular diseases

  3. patient mortality

    Time frame: 96 weeks

    different rates of all-cause patient mortality and cardiovascular mortality

  4. technique failure

    Time frame: 96 weeks

    different incidence of technique failure during peritoneal dialysis treatment

Secondary outcomes

  1. blood pressure

    Time frame: 96 weeks

    change in blood pressure

  2. residual renal function

    Time frame: 96 weeks

    decline rate of residual renal function

  3. peritoneal function

    Time frame: 96 weeks

    differences of peritoneal solute transport rate

  4. heart function

    Time frame: 96 weeks

    differences of ejection fraction (EF) in echocardiography

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients: A Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 29, 2016
Registry last updated
Nov 22, 2024

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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