Control Of Fluid Balance Guided by Body Composition Monitoring in Patients on PeritoneAl dialySiS (COMPASS)

Seoul National University

Status: Completed

Conditions: Peritoneal Dialysis, Continuous Ambulatory

Treatments: Procedure: Fluid management based on the clinical information alone; Device: BCM-guided fluid management

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01887262

COMPASS (Other Identifier)

Details and patient eligibility

About

Bioimpedance-guided fluid management in peritoneal dialysis patients may provide better protection of residual renal function over 1 year period, compared with management guided by clinical information alone - such as blood pressure, body weight, and physician's physical examination.

Enrollment: 108 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age bwten 20 and 75
• peritoneal dialysis > 4 weeks duration
• written consent
• daily urine output > 500 ml

Exclusion criteria

• subjects who are contraindicated to the bioimpedance measurement (pacemaker insertion state, defibrillator state, amputee, prosthesis, metal implants)
• pregnant women
• subjects who are expected to discontinue peritoneal dialysis with one year
• mixed dialysis modality (peritoneal + hemodialysis)
• hypoalbuminemic subjects (serum albumin < 3.3 g/dL)
• high blood pressure (> 160/100 mmHg despite antihypertensive medications)
• severe heart failure (NYHA FC III, or IV)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

108 participants in 2 patient groups

Intervention

Experimental group

Description:

Incident peritoneal dialysis (PD) patients who are randomly allocated to BCM-guided fluid management will receive BCM measurement every two months over 1-year period. The BCM results will be notified to the physicians and the participating subjects. Based on the BCM results along with the clinical information such as blood pressure, edema and weight, the physicians will prescribe PD fluid and diuretics, targeting within 1L of overhydration status. They will prescribe dietary education to the patient, if necessary.

Treatment:

Device: BCM-guided fluid management

Control

Active Comparator group

Description:

BCM will be measured at the beginning and end of the study, respectively. However, the BCM results will be blinded to the physicians and the control group. The physician will prescribe drugs, PD fluids, and dietary education to the patients based on the clinical information alone - such as blood pressure, edema and body weight.

Treatment:

Procedure: Fluid management based on the clinical information alone