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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

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.

Condition or disease Intervention/treatment Phase
Potential Applications for Heart Failure Volume Overload Drug: Two-hour dwell with 10% dextrose in sterile water Drug: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Zero Sodium Peritoneal Dialysate Protocol in Human Pilot Study
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03801226


Contacts
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Contact: Devin D Mahoney 203-737-6227 devin.mahoney@yale.edu
Contact: Jeffrey M Testani 203-737-6227 jeffrey.testani@yale.edu

Locations
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United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
Contact: Jeffrey Testani, MD       jeffrey.testani@yale.edu   
Sponsors and Collaborators
Yale University

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Responsible Party: Jeffrey Testani, Associate Professor of Medicine, Yale University
ClinicalTrials.gov Identifier: NCT03801226     History of Changes
Other Study ID Numbers: 2000023570
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jeffrey Testani, Yale University:
Peritoneal dialysis

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Calcium
Calcium, Dietary
Dialysis Solutions
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmaceutical Solutions