Peritoneal Dialysis ComplicationTransDiPeNCT04102527
Evaluation of the Impact of Transit Troubles in Patients Undergoing Peritoneal Dialysis
An observational study of Peritoneal Dialysis Complication and Constipation, run by Centre Hospitalier de Vichy at 1 site in France.
Trial summary
Patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis (PD) often have pathophysiological factors that promote chronic constipation. It affects the quality of life of Patients undergoing PD in a much greater way than for hemodialysis patients because it causes complications, mechanical and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis Complication, Constipation
- What is being tested?
- Questionnaires
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2019to 31 Dec 2024
- Phase
- Observational
- 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
Study population: Clinically stable patients who have been in Peritoneal Dialysis for at least three months will be pre-selected three months before the start of the study and included via the Metabolic diseases Center of the Hospital. This protocol will be offered to adult patients suffering from Terminal Chronic Kidney disease undergoing Peritoneal Dialysis. The investigator will inform the details of the protocol and answer all questions from patients. It will be given sufficient time to reflect for the signing of the information and non-opposition form. Volunteers will be included after signing this document.
Who may be able to join
- Patients with TerminalChronic Kidney disease undergoing Peritoneal Dialysis for at least three months in stable condition,
- Patients who are able to complete the study questionnaires every 2 months,
- Cooperation and understanding sufficient to comply with the requirements of the study,
- Ability to understand the French language for an informed understanding of the information and non-opposition forms,
- Affiliation with the French Social Security scheme.
Who cannot join
- Patients whose peritoneal dialysis catheter is considered non-functional at J0,
- Patients with a medical and/or surgical history considered by the investigator or his representative to be not compatible with the trial,
- Patients with unstabilized progressive pathology at the time of inclusion at J0,
- Patients who are mentally incapacitated to answer questionnaires,
- Women of childbearing age who do not use an effective contraceptive method, pregnant or lactating women.
- Patients with legal protection measures (curatorship, guardianship, etc.).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospital center
Vichy, 03200
Delphine ROUX, 0033470971314, delphine.roux@ch-vichy.fr
Didier AGUILERA
About this study
Official title: Evaluation of the Impact of Transit Troubles in Patients Undergoing Peritoneal
Patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis (PD) often have pathophysiological factors that promote chronic constipation. It affects the quality of life of Patients undergoing PD in a much greater way than for hemodialysis patients because it causes complications, mechanical and infectious associated with the transmural migration of enteral bacteria, with an impact on patient morbidity and survival of the technique. In addition, it should be noted that PD patients often take potentially constipants treatments such as phosphorus chelators, calcium inhibitors, opiates, iron preparation and antidepressants. Taking these drugs decreases gastric acidity, which is associated with an increased prevalence of peritonitis.
In this context, a significant lack of literature, specifically studying the risk factors for constipation in Terminal Chronic Kidney Disease patients treated with DP and the correlation with mechanical and infectious complications, is improvable.
Read the detailed description
Patients included in this trial will be monitored as part of the usual management of their pathology, a Terminal Chronic Kidney Disease treated by the Peritoneal Dialysis technique.
During this treatment, patients will be follow every 2 months in consultation in the Metabolic Diseases Department of the Hospital of Vichy.
These consultations include:
- Pre-selection consultation/Inclusion (visit to J0 -3 months)
- Half-yearly review (visit J0, visit at 12 months and visit at 24 months)
- Simple consultation (visits to 2, 4, 8, 10, 14, 16, 20, 22 months)
- Annual review (visits at 6 and 18 months)
In this prospective trial, there is no intervention on the patient; They will only have to complete questionnaires on their intestinal transit (Charlson Scale, Katz Scale, Neurological Functional Score, Intestinal Function Index, Severity Score for constipation, Bristol Scale, Constipation Assessment Scale, Constipation Risk Assessment Scale). No minimal risk and constraint is identified, excluding our trial from the category of interventional research. The category 3 (non-interventional trial) of the jardé classification is therefore accepted.
- Conditions
- Peritoneal Dialysis Complication, Constipation
- Being tested
- Questionnaires
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Patients have to complete the study questionnaires every 2 months :
- Digestive Functional Score of Neurological Patients
- Bowel Function Index
- Severity score for constipation
- Bristol Scale
- Constipation assessment scale
- Estimate scale of risk of constipation
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis for at least three months in stable condition Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether there is a relationship between transit disorders and the rate of digestive germ peritonitis in patients with Terminal Chronic Kidney disease on Peritoneal Dialysis
The investigators will count the number of peritonitis associated with transit disorders in patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis
Measured: 4 years
Secondary outcomes (1)
To determine whether there are variations in the relationship between transit disorders and the rate of peritonitis depending on the therapeutic management of these transit disorders.
To assess the existence of an episode of peritonitis from all causes
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start19 Dec 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis ComplicationStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Vichy
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Clermont-Ferrand
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102527
- Sponsor's protocol ID
- CHV 2018-1
- Acronym
- TransDiPe
- Status last verified
- Sep 2022
- First submitted
- 23 Sep 2019
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Source documents defined as any original document or object to prove the existence or accuracy of a data or fact recorded during the clinical study will be kept for 15 years by the Hospital Center; this is the hospital medical record, original results of the patient's biological examinations. The protocol data that will be collected in the observation book and which will be considered source data can be found in the attached observation book. Source data will be collected by the service's investigators and nurses; It will be collected in the CRF by investigators. The data will then be entered into the Excel database by the clinical research officer and a team member (investigator, intern or IDE) for a double entry. During or after the research, data collected on the appropriate individuals and transmitted to the sponsor by investigators will be anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Transit Troubles in Patients Undergoing Peritoneal
- ClinicalTrials.gov ID
- NCT04102527
- Acronym / sponsor ID
- TransDiPe / CHV 2018-1
- Conditions
- Peritoneal Dialysis Complication, Constipation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Centre Hospitalier de VichyUniversity, hospital or other
- Collaborators
- University Hospital, Clermont-Ferrand
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Sep 2019 (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.
Patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis (PD) often have pathophysiological factors that promote chronic constipation. It affects the quality of life of Patients undergoing PD in a much greater way than for hemodialysis patients because it causes complications, mechanical and infectious associated with the transmural migration of enteral bacteria, with an impact on patient morbidity and survival of the technique. In addition, it should be noted that PD patients often take potentially constipants treatments such as phosphorus chelators, calcium inhibitors, opiates, iron preparation and antidepressants. Taking these drugs decreases gastric acidity, which is associated with an increased prevalence of peritonitis.
In this context, a significant lack of literature, specifically studying the risk factors for constipation in Terminal Chronic Kidney Disease patients treated with DP and the correlation with mechanical and infectious complications, is improvable.
Detailed description
Patients included in this trial will be monitored as part of the usual management of their pathology, a Terminal Chronic Kidney Disease treated by the Peritoneal Dialysis technique.
During this treatment, patients will be follow every 2 months in consultation in the Metabolic Diseases Department of the Hospital of Vichy.
These consultations include:
- Pre-selection consultation/Inclusion (visit to J0 -3 months)
- Half-yearly review (visit J0, visit at 12 months and visit at 24 months)
- Simple consultation (visits to 2, 4, 8, 10, 14, 16, 20, 22 months)
- Annual review (visits at 6 and 18 months)
In this prospective trial, there is no intervention on the patient; They will only have to complete questionnaires on their intestinal transit (Charlson Scale, Katz Scale, Neurological Functional Score, Intestinal Function Index, Severity Score for constipation, Bristol Scale, Constipation Assessment Scale, Constipation Risk Assessment Scale). No minimal risk and constraint is identified, excluding our trial from the category of interventional research. The category 3 (non-interventional trial) of the jardé classification is therefore accepted.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: QuestionnairesPatients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis for at least three months in stable condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinically stable patients who have been in Peritoneal Dialysis for at least three months will be pre-selected three months before the start of the study and included via the Metabolic diseases Center of the Hospital. This protocol will be offered to adult patients suffering from Terminal Chronic Kidney disease undergoing Peritoneal Dialysis. The investigator will inform the details of the protocol and answer all questions from patients. It will be given sufficient time to reflect for the signing of the information and non-opposition form. Volunteers will be included after signing this document.
Key inclusion criteria (5 listed)
- Patients with TerminalChronic Kidney disease undergoing Peritoneal Dialysis for at least three months in stable condition,
- Patients who are able to complete the study questionnaires every 2 months,
- Cooperation and understanding sufficient to comply with the requirements of the study,
- Ability to understand the French language for an informed understanding of the information and non-opposition forms,
- Affiliation with the French Social Security scheme.
Key exclusion criteria (6 listed)
- Patients whose peritoneal dialysis catheter is considered non-functional at J0,
- Patients with a medical and/or surgical history considered by the investigator or his representative to be not compatible with the trial,
- Patients with unstabilized progressive pathology at the time of inclusion at J0,
- Patients who are mentally incapacitated to answer questionnaires,
- Women of childbearing age who do not use an effective contraceptive method, pregnant or lactating women.
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 |
|---|---|---|
| QuestionnairesPatients have to complete the study questionnaires every 2 months : * Digestive Functional Score of Neurological Patients * Bowel Function Index * Severity score for constipation * Bristol Scale * Constipation assessment scale * Estimate scale of risk of constipation | Other | Patients |
Primary outcome
To determine whether there is a relationship between transit disorders and the rate of digestive germ peritonitis in patients with Terminal Chronic Kidney disease on Peritoneal Dialysis
Time frame: 4 years
The investigators will count the number of peritonitis associated with transit disorders in patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis
1 secondary outcome
To determine whether there are variations in the relationship between transit disorders and the rate of peritonitis depending on the therapeutic management of these transit disorders.
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No. Source documents defined as any original document or object to prove the existence or accuracy of a data or fact recorded during the clinical study will be kept for 15 years by the Hospital Center; this is the hospital medical record, original results of the patient's biological examinations. The protocol data that will be collected in the observation book and which will be considered source data can be found in the attached observation book. Source data will be collected by the service's investigators and nurses; It will be collected in the CRF by investigators. The data will then be entered into the Excel database by the clinical research officer and a team member (investigator, intern or IDE) for a double entry. During or after the research, data collected on the appropriate individuals and transmitted to the sponsor by investigators will be anonymized.
Related trials for Peritoneal Dialysis Complication
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
Kidney Failure
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
RecruitingPhase 2
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication
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.
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 Complication and Constipation, run by Centre Hospitalier de Vichy at 1 site in France.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Sep 2022. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Delphine ROUX (0033470971314, delphine.roux@ch-vichy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether there is a relationship between transit disorders and the rate of digestive germ peritonitis in patients with Terminal Chronic Kidney disease on Peritoneal Dialysis (time frame: 4 years). 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 8 Sep 2022.