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

2 juin 2026 mis à jour par: Olof Heimburger, Karolinska Institutet
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.

Aperçu de l'étude

Description détaillée

Patients treated with peritoneal dialysis (PD)are investigated twice of different days with a single 4h dwell study: once with solution with a solution with bicarbonate 15 mmol/L abd Lactate 15 mmol/L as buffer (Physioneal TM) and once with conventional lactate-buffered (40 mmol/L) PD solution (Dianeal TM). Aproximately 2 liter of PD solution was infused each time. Intraperitoneal fluid was sampled during the dwell at t = 0, 3, 6, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 minutes from the end of the dialysis fluid infusion and the start of the peritoneal dwell. Venous blood samples were drawn from the patient before the start of the dwell and at t = 15, 60, 120, 240 minutes.

New and spent dialysate bags were weighed before and after each dwell to assess infused and drain volumes, respectively; the volumes were adjusted for the weight of the empty bags. Radio-iodinated serum albumin (RISA) added to the solutions before infusion was used as volume marker to estimate intraperitoneal volume. The residual volume (after the previous dwell) was calculated from the dilution of the marker upon infusion of fresh dialysate; after the dwell the peritoneal cavity was rinsed with 1 liter of solution (glucose 1.36%) in order to estimate post-drain residual volume.

Ultrafiltration volume was calculated from the changes in intraperitoneal volume (using 3 minutes after infusion as reference) and corrected for volumes of taken samples. The rate of peritoneal absorption was estimated from the disappearance of the marker from the peritoneal cavity].

The composition of the pre-dialysis (residual) fluid was assessed based on the sample taken from the spent dialysate from the previous dwell.

Concentrations of urea, creatinine, glucose, phosphate, chloride, and lactate, in plasma and dialysate, were measured by Monarch 1000 (Instrumentation Laboratory, MA), while flame photometry was used for sodium and potassium. Dialysate pH was measured with a pH meter. The concentrations of calcium, CO2, bicarbonate, and plasma pH were measured by AVL OMNI Combi Blood Gas Analyzer (AVL, Graz, Austria). The plasma concentrations of glucose, sodium, urea, creatinine, potassium, chloride, and phosphate were corrected for plasma water fraction. Creatinine measurements in dialysate were corrected for glucose concentration. Albumin and beta-2 microglobulin (B2M) concentration were measured with immunological methods.

Advanced mathematical modelling is used to analyze the results and tgo asses transport parameters.

Type d'étude

Interventionnel

Inscription (Réel)

7

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Stockholm, Suède, S-141 86
        • Research unit, renal medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • patient treated with peritoneal dialysis in a clinically stable condition

Exclusion Criteria:

  • none

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Bicarbonate lactate solution investigatd first
The patients were studied with the bicarbonate-lactate solution the first study day and with conventional lactate.based solution on a later day.
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.
Expérimental: Lactate solution investigated first
The patients were studied with the conventional lactate.based solution the first study day and with bicarbonate-lactate solution on a later day.
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Difference in net ultrafiltration (ml)
Délai: 4 hours
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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changes to acid-base homeostasis
Délai: 4 hours
Assessment of pH, concentrationa of bicarbonate and lactate i dialysate and plasma. Frequent dialysate sampling will be used and plasma levels will be assessed mutiple times. For each solute, the mass removed/absorbed will be calculated as the difference between the dialysate mass the end of the dwell (dialysate concentration times dialysate volume, corrected for total volume of samples) and mass immediately after infusion of fresh dialysate. The latter is calculated adding up the mass in residual and infused fluids. As the conventional lactate-buffered solution is acidic (pH 5.3) and the bicarbonate-lactate buffered solution is neutral (pH 7.4) the difference in pH between the solutions over time of the dwell may be described.
4 hours
Differences in small solute transport
Délai: 4 hours
Frequent dialysate sampling will be used and plasma levels will be assessed mutiple times for several small solutes. For each solute, the mass removed/absorbed will be calculated as the difference between the dialysate mass the end of the dwell (dialysate concentration times dialysate volume, corrected for total volume of samples) and mass immediately after infusion of fresh dialysate. The latter is calculated adding up the mass in residual and infused fluids. As the conventional lactate-buffered solution is acidic (pH 5.3) and the bicarbonate-lactate buffered solution is neutral (pH 7.4) it makes it possible to assess if pH affects transport characteristics of other solutes, in particular small solutes (Na, K, Ca, bicarbonate, lactate, creatinine, urea).
4 hours
Differences in protein transport
Délai: 4 hours
Frequent dialysate sampling will be used and plasma levels will be assessed mutiple times for several small solutes. For each solute, the mass removed/absorbed will be calculated as the difference between the dialysate mass the end of the dwell (dialysate concentration times dialysate volume, corrected for total volume of samples) and mass immediately after infusion of fresh dialysate. The latter is calculated adding up the mass in residual and infused fluids. As the conventional lactate-buffered solution is acidic (pH 5.3) and the bicarbonate-lactate buffered solution is neutral (pH 7.4) it makes it possible to assess if pH affects transport characteristics of proteins (albumin and beta-2-microglobuline).
4 hours

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

9 septembre 1997

Achèvement primaire (Réel)

13 novembre 1997

Achèvement de l'étude (Réel)

13 novembre 1997

Dates d'inscription aux études

Première soumission

12 mai 2026

Première soumission répondant aux critères de contrôle qualité

29 mai 2026

Première publication (Réel)

2 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Description du régime IPD

This study was performed almost 30 years ago. A reasonalbe request for data sharing will be considered as stated in the publications from the study

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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