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Evaluation of the Impact of Transit Troubles in Patients Undergoing Peritoneal Dialysis

Evaluation of the Impact of Transit Troubles in Patients Undergoing Peritoneal

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04102527
Acronym
TransDiPe
Enrollment
180
Registered
2019-09-25
Start date
2019-12-19
Completion date
2024-12-31
Last updated
2022-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation, Peritoneal Dialysis Complication

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.

Interventions

OTHERQuestionnaires

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

Sponsors

University Hospital, Clermont-Ferrand
CollaboratorOTHER
Centre Hospitalier de Vichy
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.).

Design outcomes

Primary

MeasureTime frameDescription
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 Dialysis4 yearsThe investigators will count the number of peritonitis associated with transit disorders in patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis

Secondary

MeasureTime frameDescription
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.4 yearsTo assess the existence of an episode of peritonitis from all causes

Countries

France

Contacts

Primary ContactDelphine ROUX
delphine.roux@ch-vichy.fr0033470971314

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026