The Role of Peritoneal Dialysis in Patients With Refractory Heart Failure and Chronic Kidney Disease

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT01758627

Collaborator

(none)

Enrollment

Location

Arms

22.2

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In patients with advanced heart failure (HF), systemic congestion is the main indication for hospitalization. Recent evidence has highlighted the role of fluid retention in the pathogenesis of renal dysfunction and subsequent diuretic resistance. Previous kidney disease, diuretic resistance, and progression of renal dysfunction often coexist in patients with HF and persistent volume overload. This clinical presentation represents the most extreme feature of the cardio-renal syndrome. However, available therapeutic options for this ominous condition are scarce and limited. Indeed, there are no data from randomized control trials using pharmacological interventions that support the beneficial effect on survival. Interestingly, intermittent ultrafiltration has recently emerged as an alternative therapeutic option for reducing volume overload in patients with refractory HF. Current literature suggests that it has potential advantages over standard medical treatment particularly in acute stages of HF. Among ultrafiltration methods, peritoneal dialysis (PD) has been preferred as an additional resource for the treatment of advanced congestive heart failure (CHF) compared with hemodialysis because it can provide a more physiological and continuous ultrafiltration. In fact, several studies showed that use of PD improved clinical functional class and hemodynamic parameters and reduced hospitalization rates in patients with CHF. Nevertheless, most studies were limited by retrospective analyses of small sample size, prospective observational design with no control group, or inclusion of patients with end-stage renal failure. Therefore, well-designed prospective randomized controlled studies are mandatory to confirm the effects of PD in these patients.

Condition or Disease	Intervention/Treatment	Phase
Refractory Heart Failure Chronic Kidney Disease	Drug: Peritoneal dialysis (PD)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Oct 8, 2015

Actual Study Completion Date :

Oct 8, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Peritoneal dialysis group
Experimental: Conventional treatment group medical treatment such as diuretics	Drug: Peritoneal dialysis (PD) PD exchanges will be customized depending on patient fluid status. At least one daily exchange of icodextrin PD solution will be provided to PD group. Other Names: PD exchanges will be customized depending on patient fluid status. At least one daily exchange of icodextrin PD solution will be provided to PD group.

Arm

Intervention/Treatment

No Intervention: Peritoneal dialysis group

Experimental: Conventional treatment group

medical treatment such as diuretics

Drug: Peritoneal dialysis (PD)

PD exchanges will be customized depending on patient fluid status. At least one daily exchange of icodextrin PD solution will be provided to PD group.

Other Names:

PD exchanges will be customized depending on patient fluid status. At least one daily exchange of icodextrin PD solution will be provided to PD group.

Outcome Measures

Primary Outcome Measures

Changes of New York Heart Association (NYHA) functional class [at 0 (±1 week), 12 (±1 week), and 24 (±1 week) weeks)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

At least two non-planned admissions for acute heart failure (AHF), the last episode being in the past 6 months
New York Heart Association (NYHA) functional class III/IV and left ventricular ejection fraction (LVEF) less than 40%
Persistent congestion despite optimal loop diuretic therapy
Presence of renal dysfunction [estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2] documented at least once in the last 6 months

Exclusion Criteria:

< 20 years of age
Pregnancy
Unsuitable for PD (patients with major abdominal wall defects)
Allergic to starch or other contraindication to icodextrin (5) End-stage renal disease (eGFR < 10 ml/min/1.73 m2) requring dialysis treatment