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

Constipation Clinical Trial

— TransDiPe  

Official title:

Evaluation of the Impact of Transit Troubles in Patients Undergoing Peritoneal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04102527
• Other study ID #: CHV 2018-1
• Status: Recruiting
• Start date: December 19, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2022
• Source: Centre Hospitalier de Vichy
• Contact: Delphine ROUX
• Phone: 0033470971314
• Email: delphine.roux[@]ch-vichy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Constipation
• Peritoneal Dialysis Complication

Intervention

Other:
• Questionnaires
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

Locations

Country	Name	City	State
France	Hospital center	Vichy

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier de Vichy	University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 years
Secondary	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	4 years