Fluid Overload in Peritoneal Dialysis

Phase 4

Completed

• Conditions: End Stage Renal Disease
• Interventions: Behavioral: Aggressive fluid management

• Registration Number: NCT02557347
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

The objective of this study is to determine the effectiveness of treating peritoneal dialysis (PD) patients with fluid overload by a structured nurse-lead intervention protocol. We plan to recruit 100 PD patients with fluid overload. These patients will be assessed and managed by a renal nurse specialist in the ambulatory renal center according to a standardized protocol. The improvement in the degree of overhydration will be determined by bioimpedance spectroscopy 4 and 12 weeks after treatment.

Detailed Description

Fluid overload is a common problem in peritoneal dialysis (PD) patients and it is associated with left ventricular hypertrophy and other adverse cardiac consequences. Fluid management is therefore an important aspect in the management of dialysis patient. In Hong Kong, PD patients with common medical problems related to dialysis are assessed and managed in the renal nurse clinic by pre-approved intervention protocols. Although it is the general impression that management of PD patients with fluid overload by a nurse-lead intervention protocol is robust and could reduce the work load of medical staff, the efficacy of this approach remains undetermined. The objective of this study is to determine the effectiveness of treating PD patients with fluid overload by a structured nurse-lead intervention protocol. We plan to recruit 100 PD patients with fluid overload, which is defined as overhydration (OH) ≥ 2 litres as measured by bioimpedance spectroscopy. These patients will be assessed and managed by a renal nurse specialist in the ambulatory renal center according to a standardized protocol previously approved by the Hospital Authority. The improvement in the degree of overhydration will be determined by bioimpedance spectroscopy 4 and 12 weeks after treatment. Change in body weight, blood pressure, degree of oedema, as well as the knowledge on salt and fluid restriction will also be assessed.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-23
• Primary Completion: 2015-12
• Study Completion: 2016-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-27
• Last Update Posted: 2016-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• PD patients with overhydration (OH) ≥ 2 litres as measured by bioimpedance spectroscopy

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Exclusion Criteria

• overt pulmonary edema and required urgent medical care
• cognitive impairment or problem of communication
• unlikely to survive for more than three months
• mechanical problems of the dialysis catheter
• active peritonitis or peritoneal failure

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Aggressive fluid management	Aggressive fluid management

Primary Outcome Measures

Name	Time	Method
degree of overhydration	12 weeks	measured by bioimpedance spectroscopy

Secondary Outcome Measures

Name	Time	Method
blood pressure	12 weeks
patient knowledge	12 weeks	questionnaire assessment

Trial Locations

Locations (1)

Renal Unit, Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong