Zero Sodium Peritoneal Dialysate Protocol Pilot Study

Yale University

Status and phase: Completed; Early Phase 1

Conditions: Volume Overload; Potential Applications for Heart Failure

Treatments: Drug: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose; Drug: Two-hour dwell with 10% dextrose in sterile water

Study type: Interventional

Funder types: Other

Identifiers

NCT03801226

2000023570

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

10% dextrose in sterile water

Experimental group

Description:

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.

Treatment:

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

Drug: Two-hour dwell with 10% dextrose in sterile water

Dianeal Low-Calcium with 4.25% Dextrose

Active Comparator group

Description:

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.

Treatment:

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

Drug: Two-hour dwell with 10% dextrose in sterile water