Clinical trial NCT04102527: Evaluation of the Impact of Transit Troubles in Patients Undergoing Peritoneal Dialysis
Official title: Evaluation of the Impact of Transit Troubles in Patients Undergoing Peritoneal
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peritoneal Dialysis Complication
Constipation
Lead sponsor: Centre Hospitalier de Vichy
Sponsor class: OTHER
Collaborators: name: University Hospital, Clermont-Ferrand
First posted: 2019-09-25
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.).

Primary outcomes:
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
timeFrame: 4 years
Secondary outcomes:
measure: 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.
timeFrame: 4 years
Other outcomes:
Locations:
city: Vichy
country: France
facility: Hospital center
Study officials:
References: