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Clinical Trials/NCT02557347
NCT02557347
Completed
Phase 4

The Efficacy of Managing Fluid Overload in Peritoneal Dialysis Patient by a Structured Nurse-lead Intervention Protocol

Chinese University of Hong Kong1 site in 1 country102 target enrollmentJune 2013

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
End Stage Renal Disease
Sponsor
Chinese University of Hong Kong
Enrollment
102
Locations
1
Primary Endpoint
degree of overhydration
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cheuk-Chun SZETO

Professor

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

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

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

Outcomes

Primary Outcomes

degree of overhydration

Time Frame: 12 weeks

measured by bioimpedance spectroscopy

Secondary Outcomes

  • blood pressure(12 weeks)
  • patient knowledge(12 weeks)

Study Sites (1)

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