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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Yonsei University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01758627
First Posted: January 1, 2013
Last Update Posted: February 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose
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 Intervention
Refractory Heart Failure Chronic Kidney Disease Drug: Peritoneal dialysis (PD)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Changes of New York Heart Association (NYHA) functional class [ Time Frame: at 0 (±1 week), 12 (±1 week), and 24 (±1 week) weeks) ]

Estimated Enrollment: 44
Study Start Date: December 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least two non-planned admissions for acute heart failure (AHF), the last episode being in the past 6 months
  2. New York Heart Association (NYHA) functional class III/IV and left ventricular ejection fraction (LVEF) less than 40%
  3. Persistent congestion despite optimal loop diuretic therapy
  4. 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:

  1. < 20 years of age
  2. Pregnancy
  3. Unsuitable for PD (patients with major abdominal wall defects)
  4. Allergic to starch or other contraindication to icodextrin (5) End-stage renal disease (eGFR < 10 ml/min/1.73 m2) requring dialysis treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758627


Contacts
Contact: TaeHyun Yoo, MD 82-2-2228-1975 YOOSY0316@yuhs.ac

Locations
Korea, Republic of
Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: TaeHyun Yoo, M.D., Ph,D    82-2-2228-1975    YOOSY0316@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01758627     History of Changes
Other Study ID Numbers: 4-2012-0750
First Submitted: December 24, 2012
First Posted: January 1, 2013
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by Yonsei University:
Peritoneal dialysis,
chronic kidney disease,
refractory heart failure

Additional relevant MeSH terms:
Heart Failure
Kidney Diseases
Renal Insufficiency, Chronic
Heart Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Icodextrin
Dialysis Solutions
Pharmaceutical Solutions


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