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Zero Sodium Peritoneal Dialysate Protocol Pilot Study

NCT ID: NCT03801226

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-05-31

Brief Summary

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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

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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.

Conditions

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Potential Applications for Heart Failure Volume Overload

Keywords

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Peritoneal dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Two-hour dwell with 10% dextrose in sterile water

Intervention Type DRUG

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.

Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

Two-hour dwell with 10% dextrose in sterile water

Intervention Type DRUG

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.

Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey Testani

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Rao VS, Turner JM, Griffin M, Mahoney D, Asher J, Jeon S, Yoo PS, Boutagy N, Feher A, Sinusas A, Wilson FP, Finkelstein F, Testani JM. First-in-Human Experience With Peritoneal Direct Sodium Removal Using a Zero-Sodium Solution: A New Candidate Therapy for Volume Overload. Circulation. 2020 Mar 31;141(13):1043-1053. doi: 10.1161/CIRCULATIONAHA.119.043062. Epub 2020 Jan 8.

Reference Type DERIVED
PMID: 31910658 (View on PubMed)

Other Identifiers

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2000023570

Identifier Type: -

Identifier Source: org_study_id