Peritoneal Transport With a New Bicarbonate-based Peritoneal Dialysis Solution Compared to Conventional Solution.

NCT07621627 | Completed Phase 3

• 1 other identifier: Dnr 283/96
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Cross-over study. Patients treated with peritoneal dialysis are investigated twice with a single 4h dwell study: once with Bicarbonate-Lactate solution as buffer (Physioneal TM) and once with conventional lactate PD solution (Dianeal TM). Radioidinated human serum albumin is used as a volume marker to assess ultrafiltration and frequent dialysis and blood sampling to assess peritneal transport of solutes and pH changes.

Conditions

Chronic Renal Failure (CRF); Dialysis Dependent Chronic Kidney Disease

Keywords

peritoneal dialysis; Peritoneal dialysis solution; peritoneal solute transport; acid-base balance

Outcome Measures

Primary Outcomes (1)

• Difference in net ultrafiltration (ml)

  Assessment of fluid transport during a PD dwell. Intraperitoenal volume changes during the 4 hour dwells will be assesed from dilution of the added volume marker with correction for absorption of the marker. Amount of marker remaining in the drained fluid after four hours will be subratcted from the initial added amount to calculate amount of marker absorbed during the dwell. Residual volumes before and after the dwell can also be calculated from dilution of the marker. This makes it possible to calculate the intraperitoneal volume of time curve during the dwell and net ultrafiltration (=net fluid removal). To simplify, the intraperitoneal volume (ml) at 240 minutes of the dwell minus the intraperitoneal volume after infusion of the dialysis fluid.

  4 hours

Secondary Outcomes (3)

• Changes to acid-base homeostasis

  4 hours

• Differences in small solute transport

  4 hours

• Differences in protein transport

  4 hours

Study Arms (2)

Bicarbonate lactate solution investigatd first

EXPERIMENTAL

The patients were studied with the bicarbonate-lactate solution the first study day and with conventional lactate.based solution on a later day.

Drug: Test of peritoneal transport with bicarbonate-lactate buffered peritoneal dialysis solution and lactate solutin

Lactate solution investigated first

EXPERIMENTAL

The patients were studied with the conventional lactate.based solution the first study day and with bicarbonate-lactate solution on a later day.

Drug: Test of peritoneal transport with bicarbonate-lactate buffered peritoneal dialysis solution and lactate solutin

Interventions

Test of peritoneal transport with bicarbonate-lactate buffered peritoneal dialysis solution and lactate solutin DRUG

All patients were studied twice with a 4-h dwell study (one peritoneal dialysis dwell) about 7 days apart. The two arms represent different order of the used periteonal dialysis fluid for the two dwell studies.

Bicarbonate lactate solution investigatd first; Lactate solution investigated first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient treated with peritoneal dialysis in a clinically stable condition

You may not qualify if:

• none

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Research unit, renal medicine

Stockholm, S-141 86, Sweden

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, MD, PhD

Model Details: Patients are studied twice for four hours on different days, once with conventional PD solution at the time of the study, once with bicarbonate-lactate solution.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 2, 2026
• Study Start: September 9, 1997
• Primary Completion: November 13, 1997
• Study Completion: November 13, 1997
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

SE (1)