Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients.

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03004963
• Other study ID #: [2016]101K
• Status: Recruiting
• Phase: N/A
• First received: December 12, 2016
• Last updated: December 28, 2016
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: RenJi Hospital
• Contact: Wei Fang, Dr
• Phone: 13621722995
• Email: fangwei_sh[@]126.com
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• Body composition monitor
Both body composition monitor (BCM) is used to evaluate the volume status of patients.
• clinical indexes
The investigators evaluate the volume status of patients according to clinical indexes.

Locations

Country	Name	City	State
China	Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	volume status	change in overhydration(OH) value	96 weeks	No
Primary	The incidence of cardiovascular events	different incidence of cardiovascular diseases	96 weeks	No
Primary	patient mortality	different rates of all-cause patient mortality and cardiovascular mortality	96 weeks	No
Primary	technique failure	different incidence of technique failure during peritoneal dialysis treatment	96 weeks	No
Secondary	blood pressure	change in blood pressure	96 weeks	No
Secondary	residual renal function	decline rate of residual renal function	96 weeks	No
Secondary	peritoneal function	differences of peritoneal solute transport rate	96 weeks	No
Secondary	heart function	differences of ejection fraction (EF) in echocardiography	96 weeks	No