NCT02557347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

2.5 years

First QC Date

September 21, 2015

Last Update Submit

July 27, 2016

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

  • degree of overhydration

    measured by bioimpedance spectroscopy

    12 weeks

Secondary Outcomes (2)

  • blood pressure

    12 weeks

  • patient knowledge

    12 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Aggressive fluid management

Behavioral: Aggressive fluid management

Interventions

Aggressive fluid managementBEHAVIORAL

nursing education, dietary advice, extra hypertonic dialysis cycles

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renal Unit, Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cheuk Chun Szeto, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 23, 2015

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

July 28, 2016

Record last verified: 2016-07

Locations

HK(1)