Chronic Renal Failure (CRF)Phase 3NCT07621627
Peritoneal Transport With a New Bicarbonate-based Peritoneal Dialysis Solution Compared to Conventional Solution.
A Phase 3 study testing Test of peritoneal transport with bicarbonate-lactate buffered peritoneal dialysis solution and lactate solutin in people with Chronic Renal Failure (CRF) and Dialysis Dependent Chronic Kidney Disease, run by Karolinska Institutet at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure (CRF), Dialysis Dependent Chronic Kidney Disease
- What is being tested?
- Test of peritoneal transport with bicarbonate-lactate buffered peritoneal dialysis solution and lactate solutin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSweden
- Study dates
- 9 Sep 1997to 13 Nov 1997
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient treated with peritoneal dialysis in a clinically stable condition
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- Test of peritoneal transport with bicarbonate-lactate buffered peritoneal dialysis solution and lactate solutin
- Keywords
- peritoneal dialysis, Peritoneal dialysis solution, peritoneal solute transport, acid-base balance
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test of peritoneal transport with bicarbonate-lactate buffered peritoneal dialysis solution and lactate solutinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Test of peritoneal transport with bicarbonate-lactate buffered peritoneal dialysis solution and lactate solutin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours
Secondary outcomes (3)
Changes to acid-base homeostasis
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.
Measured: 4 hours
Differences in small solute transport
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).
Measured: 4 hours
Differences in protein transport
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).
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start9 Sep 1997
- Primary completion13 Nov 1997
- Study completion13 Nov 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal Failure (CRF)Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olof Heimburger, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621627
- Sponsor's protocol ID
- Dnr 283/96
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peritoneal Transport With a New Bicarbonate-based Peritoneal Dialysis Solution Compared to Conventional Solution.
- ClinicalTrials.gov ID
- NCT07621627
- Acronym / sponsor ID
- Dnr 283/96
- Keywords
- peritoneal dialysis, Peritoneal dialysis solution, peritoneal solute transport, acid-base balance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 9 Sep 1997 (actual)
- Primary completion
- 13 Nov 1997 (actual)
- Study completion
- 13 Nov 1997 (actual)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bicarbonate lactate solution investigatd first | Experimental | Drug: Test of peritoneal transport with bicarbonate-lactate buffered peritoneal dialysis solution and lactate solutinThe patients were studied with the bicarbonate-lactate solution the first study day and with conventional lactate.based solution on a later day. |
| Lactate solution investigated first | Experimental | Drug: Test of peritoneal transport with bicarbonate-lactate buffered peritoneal dialysis solution and lactate solutinThe patients were studied with the conventional lactate.based solution the first study day and with bicarbonate-lactate solution on a later day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient treated with peritoneal dialysis in a clinically stable condition
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test of peritoneal transport with bicarbonate-lactate buffered peritoneal dialysis solution and lactate solutinAll 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. | Drug | Bicarbonate lactate solution investigatd first, Lactate solution investigated first |
Primary outcome
Difference in net ultrafiltration (ml)
Time frame: 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.
3 secondary outcomes
Changes to acid-base homeostasis
Time frame: 4 hours
Differences in small solute transport
Time frame: 4 hours
Differences in protein transport
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Test of peritoneal transport with bicarbonate-lactate buffered peritoneal dialysis solution and lactate solutin in people with Chronic Renal Failure (CRF) and Dialysis Dependent Chronic Kidney Disease, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in net ultrafiltration (ml) (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.