Fluid Overload in Peritoneal Dialysis

Status Completed

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02557347
Study type	Interventional
Source	Chinese University of Hong Kong
Contact
Status	Completed
Phase	Phase 4
Start date	June 2013
Completion date	May 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04076488` - Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases	N/A
Completed	`NCT03289650` - Extended Release Tacrolimus vs. Twice-Daily Tacrolimus	Phase 3
Completed	`NCT04042324` - A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients	Phase 1/Phase 2
Completed	`NCT01242904` - Use of a Bimodal Solution for Peritoneal Dialysis	Phase 2
Active, not recruiting	`NCT03183245` - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis	Phase 3
Completed	`NCT03257410` - Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients	N/A
Completed	`NCT03627299` - Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors	Phase 4
Recruiting	`NCT05917795` - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates	N/A
Terminated	`NCT03539861` - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients	N/A
Withdrawn	`NCT02130817` - Belatacept in Kidney Transplantation of Moderately Sensitized Patients	Phase 4
Completed	`NCT05540457` - Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)	N/A
Not yet recruiting	`NCT04900610` - The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis	N/A
Recruiting	`NCT02176434` - Pilot Feasibility Study of Combined Kidney and Hematopoietic Stem Cell Transplantation to Cure End-stage Renal Disease	N/A
Active, not recruiting	`NCT02581449` - Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis	Phase 2
Completed	`NCT02832466` - Quantifying the Deterioration of Physical Function in Renal Patients	N/A
Completed	`NCT02134314` - C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI	Phase 1/Phase 2
Completed	`NCT02832440` - Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis	N/A
Completed	`NCT02830490` - Reliability of Functional Measures in Hemodialysis Patient.	N/A
Completed	`NCT02215655` - Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence	N/A
Recruiting	`NCT01912001` - Virtual Ward for Home Dialysis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.