Fluid Overload in Peritoneal Dialysis

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557347
• Other study ID #: FO_in_PD
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2015
• Last updated: July 27, 2016
• Start date: June 2013
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Behavioral:
• Aggressive fluid management
nursing education, dietary advice, extra hypertonic dialysis cycles

Locations

Country	Name	City	State
Hong Kong	Renal Unit, Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of overhydration	measured by bioimpedance spectroscopy	12 weeks	No
Secondary	blood pressure		12 weeks	No
Secondary	patient knowledge	questionnaire assessment	12 weeks	No