Peritoneal DialysisNCT06841224
The Factors Affecting IPP in Peritoneal Dialysis Patients with Polycystic Kidney Disease
An observational study of Peritoneal Dialysis and Polycystic Kidney Diseases, run by Peking University First Hospital at 1 site in China.
Trial summary
Background: Polycystic kidney disease (PKD) is the most common hereditary kidney disease. Peritoneal dialysis (PD) in such patients is restricted because the significantly enlarged kidneys and liver may lead to the increase of intraperitoneal pressure (IPP). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peritoneal Dialysis, Polycystic Kidney Diseases
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 30 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 polycystic kidney disease patients undergoing peritoneal dialysis at 5-10 peritoneal dialysis centers nationwide from January 2024 to June 2024.
Who may be able to join
- Aged 18-80 years;
- A confirmed diagnosis of polycystic kidney disease, with a history of peritoneal dialysis catheter placement and regular peritoneal dialysis;
- Able to tolerate the infusion of more than 1500 mL of dialysis fluid.
Who cannot join
- Acute complications such as peritonitis or cardiovascular and cerebrovascular events within the past month;
- History of abdominal surgery or trauma within the past month;
- History of kidney cyst rupture, infection, or bleeding within the past month;
- History of abdominal or pelvic organ tumors;
- History of abdominal pressure-related complications, such as hernias, leaks, or chest-abdominal fistulas;
- Unable to attend follow-up visits during the study period;
- Refusal to participate in the study. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking university First hospital
Beijing, Beijing Municipality, 100000
About this study
Background: Polycystic kidney disease (PKD) is the most common hereditary kidney disease. Peritoneal dialysis (PD) in such patients is restricted because the significantly enlarged kidneys and liver may lead to the increase of intraperitoneal pressure (IPP). Increased IPP points to higher risk of abdominal wall complications and limited infusion volume that cause insufficient dialysis adequacy. Therefore, monitoring IPP is especially important in patients with polycystic kidney disease. However, the standard measurement of IPP is limited due to its cumbersome procedures, the application value of equation for estimating IPP among general peritoneal dialysis patients is not clear in the PKD population and the variables influence the IPP is yet to be explored..
Objective: The main purpose of our study was to validate the existing IPP equations in the PKD patients. Further, more relevant variables were included to optimize the IPP equation. Monitoring IPP can guide the formulation of peritoneal dialysis prescription for ADPKD patients, reduce the occurrence of abdominal wall complications, and the clinical utility and efficiency of PD was expanded.
Methods: A multi-center cross-sectional study. The IPPs were measured using the Durand method, with whole-body and abdominal anthropometry indices, the volume of abdominal cavity, the total kidney volume and liver volume were collected. New equation for estimate IPP in PKD patients were generated by stepwise linear regression modeling. The eIPP were calculated using two developed equations previously. Then The bias, accuracy and precision of eIPP derived from new equation were compared with actual IPP by Durand method respectively.
- Conditions
- Peritoneal Dialysis, Polycystic Kidney Diseases
- Medical subject headings
- Polycystic Kidney Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
intraperitoneal pressure
Actual IPP (aIPP) was measured as previously described by Durand et al.17. The peritoneal cavity was completely emptied before the test. The patient was placed briefly in a supine position on a horizontal plane and the height of the horizontal plane was standardized for all study subjects. A graduated column (cm) was bounded to the abdominal cavity through the PD catheter, with zero level placed on the midaxillary line. Two-liter dialysate solution was infused into the peritoneal cavity. We then read the height between the column of dialysate inside the PD catheter and the midaxillary line in centimetres of water (cmH2O) at non-deep expiration (IPP exp) and non-deep inspiration (IPP insp) respectively, calculating the mean of IPP exp and IPP insp. After outflowing 500 ml of the dialysate solution, we measured the aIPP again utilizing the same procedure. As a result, aIPP was measured two times for each participant. All the measurements were performed by two skillful nurses, which had
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Apr 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841224
- Sponsor's protocol ID
- IPP in ADPKD
- Status last verified
- Jan 2025
- First submitted
- 18 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data described in the manuscript, code book, and analytic code will not be made available because the Management of China's Human Genetic Resources.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Factors Affecting IPP in Peritoneal Dialysis Patients with Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT06841224
- Acronym / sponsor ID
- IPP in ADPKD
- Conditions
- Peritoneal Dialysis, Polycystic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 24 Feb 2025 (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.
Background: Polycystic kidney disease (PKD) is the most common hereditary kidney disease. Peritoneal dialysis (PD) in such patients is restricted because the significantly enlarged kidneys and liver may lead to the increase of intraperitoneal pressure (IPP). Increased IPP points to higher risk of abdominal wall complications and limited infusion volume that cause insufficient dialysis adequacy. Therefore, monitoring IPP is especially important in patients with polycystic kidney disease. However, the standard measurement of IPP is limited due to its cumbersome procedures, the application value of equation for estimating IPP among general peritoneal dialysis patients is not clear in the PKD population and the variables influence the IPP is yet to be explored..
Objective: The main purpose of our study was to validate the existing IPP equations in the PKD patients. Further, more relevant variables were included to optimize the IPP equation. Monitoring IPP can guide the formulation of peritoneal dialysis prescription for ADPKD patients, reduce the occurrence of abdominal wall complications, and the clinical utility and efficiency of PD was expanded.
Methods: A multi-center cross-sectional study. The IPPs were measured using the Durand method, with whole-body and abdominal anthropometry indices, the volume of abdominal cavity, the total kidney volume and liver volume were collected. New equation for estimate IPP in PKD patients were generated by stepwise linear regression modeling. The eIPP were calculated using two developed equations previously. Then The bias, accuracy and precision of eIPP derived from new equation were compared with actual IPP by Durand method respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 polycystic kidney disease patients undergoing peritoneal dialysis at 5-10 peritoneal dialysis centers nationwide from January 2024 to June 2024.
Key inclusion criteria (3 listed)
- Aged 18-80 years;
- A confirmed diagnosis of polycystic kidney disease, with a history of peritoneal dialysis catheter placement and regular peritoneal dialysis;
- Able to tolerate the infusion of more than 1500 mL of dialysis fluid.
Key exclusion criteria (7 listed)
- Acute complications such as peritonitis or cardiovascular and cerebrovascular events within the past month;
- History of abdominal surgery or trauma within the past month;
- History of kidney cyst rupture, infection, or bleeding within the past month;
- History of abdominal or pelvic organ tumors;
- History of abdominal pressure-related complications, such as hernias, leaks, or chest-abdominal fistulas;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
intraperitoneal pressure
Time frame: 20 minutes
Actual IPP (aIPP) was measured as previously described by Durand et al.17. The peritoneal cavity was completely emptied before the test. The patient was placed briefly in a supine position on a horizontal plane and the height of the horizontal plane was standardized for all study subjects. A graduated column (cm) was bounded to the abdominal cavity through the PD catheter, with zero level placed on the midaxillary line. Two-liter dialysate solution was infused into the peritoneal cavity. We then read the height between the column of dialysate inside the PD catheter and the midaxillary line in centimetres of water (cmH2O) at non-deep expiration (IPP exp) and non-deep inspiration (IPP insp) respectively, calculating the mean of IPP exp and IPP insp. After outflowing 500 ml of the dialysate solution, we measured the aIPP again utilizing the same procedure. As a result, aIPP was measured two times for each participant. All the measurements were performed by two skillful nurses, which had
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No. Data described in the manuscript, code book, and analytic code will not be made available because the Management of China's Human Genetic Resources.
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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.
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?
An observational study of Peritoneal Dialysis and Polycystic Kidney Diseases, run by Peking University First Hospital at 1 site in China.
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 3 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 24 Feb 2025. 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 China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
intraperitoneal pressure (time frame: 20 minutes). 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 24 Feb 2025.