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Zero Sodium Peritoneal Dialysate Protocol Pilot Study

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ClinicalTrials.gov Identifier: NCT03801226
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey Testani, Yale University

Tracking Information
First Submitted Date  ICMJE December 12, 2018
First Posted Date  ICMJE January 11, 2019
Last Update Posted Date January 11, 2019
Actual Study Start Date  ICMJE December 1, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2019)
Safety and tolerability measured by protocol discontinuation due to patient discomfort or adverse event [ Time Frame: Two hours ]
Protocol discontinuation will be defined by premature draining of the 10% dextrose peritoneal solution (or 4.25% standard PD solution) prior to the planned two hour drain.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2019)
Comparison of total sodium removed compared to baseline [ Time Frame: Two hours ]
This exploratory efficacy outcome will be addressed by comparing the quantity of sodium removed during the two-hour dwell between the two solutions
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zero Sodium Peritoneal Dialysate Protocol Pilot Study
Official Title  ICMJE Zero Sodium Peritoneal Dialysate Protocol in Human Pilot Study
Brief Summary The following pilot study will be undertaken to determine the effects of use of a zero-sodium peritoneal dialysate solution (10% dextrose in sterile water) on sodium removal as compared to a standard peritoneal dialysis solution.
Detailed Description While heart failure (HF) is generally regarded as the inability of the heart to pump sufficient blood, on a population level, volume overload is the primary driver of morbidity and hospitalization. The signs and symptoms of volume overload are driven by water accumulation, which is initially driven by sodium retention. This overall goal of this study is to investigate the ability to remove sodium through use of a zero-sodium solution in peritoneal dialysis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Potential Applications for Heart Failure
  • Volume Overload
Intervention  ICMJE
  • Drug: Two-hour dwell with 10% dextrose in sterile water
    Patients will be randomized to undergo a two-hour dwell with 10% dextrose in sterile water at their first or second study visit and will receive the alternate intervention at the other study visit.
  • Drug: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose
    Patients will be randomized to undergo a two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose at their first or second study visit and will receive the alternate intervention at the other study visit.
Study Arms  ICMJE
  • Experimental: 10% dextrose in sterile water
    Patients randomized to this arm will undergo a two-hour dwell with 10% dextrose in sterile water at their first visit and Dianeal Low-Calcium with 4.25% Dextrose at their second visit.
    Interventions:
    • Drug: Two-hour dwell with 10% dextrose in sterile water
    • Drug: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose
  • Active Comparator: Dianeal Low-Calcium with 4.25% Dextrose
    Patients randomized to this arm will undergo a two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose at their first visit and 10% dextrose in sterile water at their second visit.
    Interventions:
    • Drug: Two-hour dwell with 10% dextrose in sterile water
    • Drug: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 8, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients actively undergoing peritoneal dialysis (PD) with a functioning PD catheter
  2. PD vintage < 3 years
  3. As judged by treating nephrologist to be at or above optimal volume status (i.e., not dehydrated)

Exclusion Criteria:

  1. Uncontrolled diabetes with frequent episodes of severe hyperglycemia
  2. Systolic blood pressure < 100 mmHg
  3. Serum sodium < 130 mEq/L
  4. 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
  5. Anemia with hemoglobin <8 g/dL
  6. Serum bicarbinate < 18 mEq/L
  7. Anuric renal failure
  8. Inability to give written informed consent or follow study protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Devin D Mahoney 203-737-6227 devin.mahoney@yale.edu
Contact: Jeffrey M Testani 203-737-6227 jeffrey.testani@yale.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03801226
Other Study ID Numbers  ICMJE 2000023570
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffrey Testani, Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yale University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP